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DISEASE & TREATMENT SETTING

Non-Small Cell Lung Cancer

Source-derived catalogue. This is not a treatment recommendation or a personalised trial match.

Exact scope

Non-Small Cell Lung Cancer

Source population
Not part of this definition
Disease extent
Not part of this definition
Treatment line
Not part of this definition
Stage
Not part of this definition
Resectability
Not part of this definition
Biomarkers, prior therapy and derivation
molecular
    prior therapy
      derivation status
      source-attested
      derivation note
      Derived from NCI topic(s): Non-Small Cell Lung Cancer. Strongest NCIt resolution: exact. Entity-level scope; stage, biomarker and treatment line are not yet part of this definition.
      source wording
      Source null
      107 more-specific settings
      Datroway: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration after prior therapy →Emrelis: metastatic Non-small cell lung cancer with MET stated without a specific alteration after prior therapy →Hernexeos: unresectable metastatic Non-small cell lung cancer with HER2 stated without a specific alteration, ERBB2 stated without a specific alteration after prior therapy →Hernexeos: unresectable metastatic Non-small cell lung cancer with HER2 stated without a specific alteration, ERBB2 stated without a specific alteration →Hyrnuo: metastatic Non-small cell lung cancer with HER2 stated without a specific alteration, ERBB2 stated without a specific alteration →Hyrnuo: metastatic Non-small cell lung cancer with HER2 stated without a specific alteration, ERBB2 stated without a specific alteration after prior therapy →Krazati: metastatic Non-small cell lung cancer with KRAS stated without a specific alteration after prior therapy →Lumakras: metastatic Non-small cell lung cancer with KRAS stated without a specific alteration after prior therapy →Zegfrovy: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration →Gavreto: metastatic Non-small cell lung cancer with RET fusion →Retevmo: metastatic Non-small cell lung cancer with RET fusion →Tepmetko: metastatic Non-small cell lung cancer with MET stated without a specific alteration →Exkivity: metastatic Non-small cell lung cancer with EGFR exon 20 insertion after prior therapy →LAZCLUZE: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration (first-line) →Docetaxel: unresectable metastatic Non-small cell lung cancer →ALECENSA: Non-small cell lung cancer with ALK Positive, ALK stated without a specific alteration (adjuvant) after prior therapy →IRESSA: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration (first-line) →BEIZRAY: unresectable metastatic Non-small cell lung cancer (adjuvant) after prior therapy →MEKTOVI: metastatic Non-small cell lung cancer with BRAF V600E →AXTLE: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration (first-line) after prior therapy →BRAFTOVI: metastatic Non-small cell lung cancer with BRAF V600E →IMFINZI: resectable Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration (neoadjuvant) after prior therapy →Docetaxel: unresectable metastatic Non-small cell lung cancer (adjuvant) after prior therapy →PEMETREXED DIPOTASSIUM: metastatic Non-small cell lung cancer (first-line) after prior therapy →Gemcitabine: metastatic Non-small cell lung cancer (first-line) →Pemfexy: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration (first-line) after prior therapy →Tecentriq Hybreza: metastatic Non-small cell lung cancer with PD-L1 stated without a specific alteration, EGFR stated without a specific alteration, ALK stated without a specific a →TABRECTA: metastatic Non-small cell lung cancer with MET stated without a specific alteration →Avastin: unresectable metastatic Non-small cell lung cancer (first-line) →PEMETREXED: metastatic Non-small cell lung cancer →ENSACOVE: metastatic Non-small cell lung cancer with ALK stated without a specific alteration →ZYKADIA: metastatic Non-small cell lung cancer with ALK stated without a specific alteration →TECENTRIQ: Non-small cell lung cancer with PD-L1 stated without a specific alteration (adjuvant) after prior therapy →Lorbrena: metastatic Non-small cell lung cancer with ALK stated without a specific alteration →KEYTRUDA: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration (first-line) →BIZENGRI: unresectable metastatic Non-small cell lung cancer after prior therapy →OPDIVO QVANTIG: resectable Non-small cell lung cancer (neoadjuvant) →Tafinlar: metastatic Non-small cell lung cancer with BRAF V600E →Pemetrexed: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration →Alunbrig: metastatic Non-small cell lung cancer with ALK stated without a specific alteration →Enhertu: unresectable metastatic Non-small cell lung cancer with HER2 Mutant, HER2 stated without a specific alteration, ERBB2 stated without a specific alteration after prior ther →Gilotrif: metastatic Non-small cell lung cancer with EGFR Mutation, EGFR stated without a specific alteration (first-line) →ABRAXANE: metastatic Non-small cell lung cancer (first-line) →BEIZRAY: metastatic Non-small cell lung cancer after prior therapy →Pemetrexed: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration (first-line) after prior therapy →RETEVMO: metastatic Non-small cell lung cancer with RET stated without a specific alteration →BEIZRAY: unresectable metastatic Non-small cell lung cancer →Rybrevant: metastatic Non-small cell lung cancer with MET stated without a specific alteration, EGFR stated without a specific alteration (first-line) →Docetaxel: metastatic Non-small cell lung cancer after prior therapy →AXTLE: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration →RETEVMO: metastatic Non-small cell lung cancer with RET Fusion, RET stated without a specific alteration →Vizimpro: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration (first-line) →Paclitaxel: metastatic Non-small cell lung cancer (first-line) →DOCIVYX: unresectable metastatic Non-small cell lung cancer →YERVOY: metastatic Non-small cell lung cancer with PD-L1 stated without a specific alteration, EGFR stated without a specific alteration, ALK stated without a specific alteration ( →ALYMSYS: unresectable metastatic Non-small cell lung cancer (first-line) →OPDIVO QVANTIG: resectable Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration (neoadjuvant) after prior therapy →IBTROZI: metastatic Non-small cell lung cancer with ROS1 stated without a specific alteration →CYRAMZA: metastatic Non-small cell lung cancer after prior therapy →PEMRYDI RTU: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration →Mekinist: metastatic Non-small cell lung cancer with BRAF V600E →IMJUDO: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration →TECENTRIQ: Non-small cell lung cancer with PD-L1 stated without a specific alteration (adjuvant) after prior therapy →Pemfexy: metastatic Non-small cell lung cancer →Gavreto: metastatic Non-small cell lung cancer with RET Fusion, RET fusion →KEYTRUDA QLEX: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration (first-line) →Alimta: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration (first-line) after prior therapy →JIDEYTRO: metastatic Non-small cell lung cancer with ROS1 stated without a specific alteration →Rozlytrek: metastatic Non-small cell lung cancer with ROS1 stated without a specific alteration →Zirabev: unresectable metastatic Non-small cell lung cancer (first-line) →Tecentriq Hybreza: Non-small cell lung cancer with PD-L1 stated without a specific alteration (adjuvant) after prior therapy →TECENTRIQ: metastatic Non-small cell lung cancer with PD-L1 stated without a specific alteration, EGFR stated without a specific alteration, ALK stated without a specific alteratio →BIZENGRI: unresectable metastatic Non-small cell lung cancer with HER2 stated without a specific alteration after prior therapy →Rybrevant: metastatic Non-small cell lung cancer with EGFR Exon 19 Deletion, EGFR stated without a specific alteration (first-line) →AVGEMSI: metastatic Non-small cell lung cancer (first-line) →ALECENSA: Non-small cell lung cancer with ALK stated without a specific alteration (adjuvant) after prior therapy →OPDIVO: resectable Non-small cell lung cancer with EGFR mutations, ALK rearrangements (neoadjuvant) after prior therapy →DOCIVYX: unresectable metastatic Non-small cell lung cancer (adjuvant) after prior therapy →OPDIVO: resectable Non-small cell lung cancer (neoadjuvant) →TAGRISSO: Non-small cell lung cancer with EGFR stated without a specific alteration (adjuvant) after prior therapy →OPDIVO QVANTIG: metastatic Non-small cell lung cancer after prior therapy →OPDIVO: resectable Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration (neoadjuvant) after prior therapy →JOBEVNE: unresectable metastatic Non-small cell lung cancer (first-line) →CYRAMZA: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration (first-line) →Gavreto: metastatic Non-small cell lung cancer with RET stated without a specific alteration →MVASI: unresectable metastatic Non-small cell lung cancer (first-line) →Gilotrif: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration, EGFR mutations (first-line) after prior therapy →PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND: metastatic Non-small cell lung cancer (first-line) →Alimta: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration →TAGRISSO: Non-small cell lung cancer with EGFR Mutation, EGFR stated without a specific alteration (adjuvant) after prior therapy →Vegzelma: unresectable metastatic Non-small cell lung cancer (first-line) →PEMRYDI RTU: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration (first-line) after prior therapy →DOCIVYX: metastatic Non-small cell lung cancer after prior therapy →Augtyro: metastatic Non-small cell lung cancer with ROS1 stated without a specific alteration →Xalkori: metastatic Non-small cell lung cancer with ALK stated without a specific alteration, ROS1 Positive, ROS1 positive →Rybrevant Faspro: metastatic Non-small cell lung cancer with EGFR Exon 19 Deletion, EGFR stated without a specific alteration (first-line) →Stage 0 Non-Small Cell Lung Cancer →Stage IB Non-Small Cell Lung Cancer →Stage IIIA Non-Small Cell Lung Cancer →Stage IIIA Non-Small Cell Lung Cancer →Stage IIIA Non-Small Cell Lung Cancer →locally advanced Non-Small Cell Lung Cancer →Stage IV recurrent Non-Small Cell Lung Cancer →Stage IV recurrent Non-Small Cell Lung Cancer →Stage I Non-Small Cell Lung Cancer →Stage II Non-Small Cell Lung Cancer →Stage IIIB Non-Small Cell Lung Cancer →

      Study evidence for this setting

      163 linked studies · Applicability is a draft source assessment, not a determination of your eligibility.

      NCT00101413 · Source cited / selected · Scope: narrower

      BAY43-9006 - Phase II Study in Non-Small Cell Lung Carcinoma (NSCLC)

      5 outcome links · 1 safety-group records · 1 quality-of-life measures

      →

      NCT00102804 · Source cited / selected · Scope: narrower

      Pemetrexed and Best Supportive Care Versus Placebo and Best Supportive Care in Non-Small Cell Lung Cancer (NSCLC)

      6 outcome links · 2 safety-group records · 2 quality-of-life measures

      →

      NCT00316225 · Registry condition search · Scope: narrower

      Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen

      6 outcome links · 1 safety-group records · 0 quality-of-life measures

      →

      NCT00423150 · Registry condition search · Scope: narrower

      Phase 2 Study of Temozolomide in Pre-Selected Advanced Aerodigestive Tract Cancers (Study P04273AM2)(TERMINATED)

      1 outcome links · 1 safety-group records · 0 quality-of-life measures

      →

      NCT00441337 · Registry condition search · Scope: narrower

      A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies

      6 outcome links · 4 safety-group records · 0 quality-of-life measures

      →

      NCT00446225 · Source cited / selected · Scope: narrower

      Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR

      4 outcome links · 2 safety-group records · 0 quality-of-life measures

      →

      NCT00525148 · Source cited / selected · Scope: narrower

      LUX Lung 2 Phase II Single Arm BIBW 2992 "Afatinib" in NSCLC With EGFR Activating Mutations

      6 outcome links · 2 safety-group records · 0 quality-of-life measures

      →

      NCT00531284 · Source cited / selected · Scope: narrower

      Phase 1b/2 Study of Carfilzomib in Relapsed Solid Tumors, Multiple Myeloma, or Lymphoma

      6 outcome links · 17 safety-group records · 0 quality-of-life measures

      →

      NCT00556322 · Source cited / selected · Scope: narrower

      A Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)

      6 outcome links · 2 safety-group records · 10 quality-of-life measures

      →

      NCT00585195 · Source cited / selected · Scope: narrower

      A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer

      6 outcome links · 21 safety-group records · 0 quality-of-life measures

      →

      NCT00686959 · Source cited / selected · Scope: narrower

      Chemotherapy and Radiation in Treating Participants With Stage 3 Non-Small Cell Lung Cancer

      6 outcome links · 2 safety-group records · 0 quality-of-life measures

      →

      NCT00753415 · Registry condition search · Scope: narrower

      A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors (V934-002)

      3 outcome links · 10 safety-group records · 0 quality-of-life measures

      →

      NCT00789373 · Source cited / selected · Scope: narrower

      A Study of Induction and Maintenance Treatment of Advanced Non-squamous Non-Small Cell Lung Cancer

      6 outcome links · 3 safety-group records · 2 quality-of-life measures

      →

      NCT00819169 · Registry condition search · Scope: narrower

      QUILT-3.026: AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors

      6 outcome links · 9 safety-group records · 0 quality-of-life measures

      →

      NCT00896454 · Source cited / selected · Scope: narrower

      Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium

      6 outcome links · 1 safety-group records · 0 quality-of-life measures

      →

      NCT00923481 · Registry condition search · Scope: narrower

      A Broad Multi-histology Phase II Study of the Multi-Kinase Inhibitor R935788 (Fostamatinib Disodium) in Advanced Colorectal, Non-small Cell Lung, Head and Neck Hepatocellular and R

      2 outcome links · 1 safety-group records · 0 quality-of-life measures

      →

      NCT00932893 · Source cited / selected · Scope: narrower

      An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anapla

      6 outcome links · 2 safety-group records · 5 quality-of-life measures

      →

      NCT00949650 · Source cited / selected · Scope: narrower

      BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation

      6 outcome links · 2 safety-group records · 3 quality-of-life measures

      →

      NCT00981058 · Source cited / selected · Scope: narrower

      First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin

      6 outcome links · 2 safety-group records · 3 quality-of-life measures

      →

      NCT00982111 · Source cited / selected · Scope: narrower

      First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin

      6 outcome links · 2 safety-group records · 3 quality-of-life measures

      →

      Indication-specific source history

      Dated source events, not confirmation of current approval for every use of a drug.

      2020-05-08 · Retevmo (selpercatinib) · accelerated approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-non-small-cell-lung-cancer
      event id
      fda-dd76ce3b980a0820
      event date
      2020-05-08
      event kind
      accelerated-approval
      drug or regimen
      Retevmo (selpercatinib)
      source indication text
      Adult patients with metastatic RET fusion-positive Non-Small Cell Lung Cancer (NSCLC)
      match phrase
      non-small cell lung cancer
      match status
      candidate
      status category
      verified_clinical_benefit
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-e3591ea14459aba9db9d
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2020-09-04 · Gavreto (pralsetinib) · accelerated approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-non-small-cell-lung-cancer
      event id
      fda-09ce96ddfc864901
      event date
      2020-09-04
      event kind
      accelerated-approval
      drug or regimen
      Gavreto (pralsetinib)
      source indication text
      Treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test
      match phrase
      non-small cell lung cancer
      match status
      candidate
      status category
      verified_clinical_benefit
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-f1bd2f76ea52efe6c081
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2021-02-03 · Tepmetko (tepotinib) · accelerated approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-non-small-cell-lung-cancer
      event id
      fda-c38fb46e1d42f141
      event date
      2021-02-03
      event kind
      accelerated-approval
      drug or regimen
      Tepmetko (tepotinib)
      source indication text
      Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
      match phrase
      non-small cell lung cancer
      match status
      candidate
      status category
      verified_clinical_benefit
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-c23b04eb67672e5e0497
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2021-05-28 · Lumakras (sotorasib) · accelerated approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-non-small-cell-lung-cancer
      event id
      fda-9ed32ca2bb5fe831
      event date
      2021-05-28
      event kind
      accelerated-approval
      drug or regimen
      Lumakras (sotorasib)
      source indication text
      Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.
      match phrase
      non-small cell lung cancer
      match status
      candidate
      status category
      ongoing
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-1560c86153e4a495fb2c
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2021-09-15 · Exkivity (mobocertinib) · accelerated approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-non-small-cell-lung-cancer
      event id
      fda-bf7a5aebbe84a1c9
      event date
      2021-09-15
      event kind
      accelerated-approval
      drug or regimen
      Exkivity (mobocertinib)
      source indication text
      Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy
      match phrase
      non-small cell lung cancer
      match status
      candidate
      status category
      withdrawn
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-21fd32ccc7ace4c77d83
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/withdrawn-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2022-09-21 · Retevmo (selpercatinib) · traditional approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-non-small-cell-lung-cancer
      event id
      fda-df35cefb104e0515
      event date
      2022-09-21
      event kind
      traditional-approval
      drug or regimen
      Retevmo (selpercatinib)
      source indication text
      Adult patients with metastatic RET fusion-positive Non-Small Cell Lung Cancer (NSCLC)
      match phrase
      non-small cell lung cancer
      match status
      candidate
      status category
      verified_clinical_benefit
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-e3591ea14459aba9db9d
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2022-12-12 · Krazati (adagrasib) · accelerated approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-non-small-cell-lung-cancer
      event id
      fda-3d8647b6e644dd83
      event date
      2022-12-12
      event kind
      accelerated-approval
      drug or regimen
      Krazati (adagrasib)
      source indication text
      Adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.
      match phrase
      non-small cell lung cancer
      match status
      candidate
      status category
      ongoing
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-07225e854ead88e41b45
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2023-08-09 · Gavreto (pralsetinib) · traditional approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-non-small-cell-lung-cancer
      event id
      fda-c909ea00792cf068
      event date
      2023-08-09
      event kind
      traditional-approval
      drug or regimen
      Gavreto (pralsetinib)
      source indication text
      Treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test
      match phrase
      non-small cell lung cancer
      match status
      candidate
      status category
      verified_clinical_benefit
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-f1bd2f76ea52efe6c081
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2024-02-15 · Tepmetko (tepotinib) · traditional approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-non-small-cell-lung-cancer
      event id
      fda-9385f3cdc63d9f85
      event date
      2024-02-15
      event kind
      traditional-approval
      drug or regimen
      Tepmetko (tepotinib)
      source indication text
      Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
      match phrase
      non-small cell lung cancer
      match status
      candidate
      status category
      verified_clinical_benefit
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-c23b04eb67672e5e0497
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2024-07-15 · Exkivity (mobocertinib) · withdrawal
      release id
      clinical-indications-draft-1
      disease state id
      ds-non-small-cell-lung-cancer
      event id
      fda-c6244566cc233929
      event date
      2024-07-15
      event kind
      withdrawal
      drug or regimen
      Exkivity (mobocertinib)
      source indication text
      Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy
      match phrase
      non-small cell lung cancer
      match status
      candidate
      status category
      withdrawn
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-21fd32ccc7ace4c77d83
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/withdrawn-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2025-05-14 · Emrelis (telisotuzumab vedotin-tllv) · accelerated approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-non-small-cell-lung-cancer
      event id
      fda-bc852a4da8a2bac4
      event date
      2025-05-14
      event kind
      accelerated-approval
      drug or regimen
      Emrelis (telisotuzumab vedotin-tllv)
      source indication text
      Treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy.
      match phrase
      non-small cell lung cancer
      match status
      candidate
      status category
      ongoing
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-1bdc47f45493f905a5e7
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2025-05-14 · telisotuzumab vedotin-tllv · approval notification
      release id
      clinical-indications-draft-1
      disease state id
      ds-non-small-cell-lung-cancer
      event id
      notice-1b123c30be3a05c2
      event date
      2025-05-14
      event kind
      approval-notification
      drug or regimen
      telisotuzumab vedotin-tllv
      source indication text
      FDA approved telisotuzumab vedotin-tllv, a c-Met-directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer with high c-Met protein overexpression [≥50% of tumor cells with strong staining], as determined by an FDA-approved test, who have received a prior systemic therapy.
      match phrase
      non-small cell lung cancer
      match status
      candidate
      status category
      accelerated
      has date discrepancy
      0
      source collection
      fda-approval-notice
      source key
      fda-2f7de233a4d4da06
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-telisotuzumab-vedotin-tllv-nsclc-high-c-met-protein-overexpression
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2025-06-11 · taletrectinib · approval notification
      release id
      clinical-indications-draft-1
      disease state id
      ds-non-small-cell-lung-cancer
      event id
      notice-73e400125327b95e
      event date
      2025-06-11
      event kind
      approval-notification
      drug or regimen
      taletrectinib
      source indication text
      FDA approved taletrectinib, a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer .
      match phrase
      non-small cell lung cancer
      match status
      candidate
      status category
      Source null
      has date discrepancy
      0
      source collection
      fda-approval-notice
      source key
      fda-0f7fd15d941ce1a4
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-taletrectinib-ros1-positive-non-small-cell-lung-cancer
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2025-06-23 · Datroway (datopotamab deruxtecan-dlnk) · accelerated approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-non-small-cell-lung-cancer
      event id
      fda-db0545bbaf1a88f9
      event date
      2025-06-23
      event kind
      accelerated-approval
      drug or regimen
      Datroway (datopotamab deruxtecan-dlnk)
      source indication text
      Treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
      match phrase
      non-small cell lung cancer
      match status
      candidate
      status category
      ongoing
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-b29e6e916d89560e828a
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2025-06-23 · datopotamab deruxtecan-dlnk · approval notification
      release id
      clinical-indications-draft-1
      disease state id
      ds-non-small-cell-lung-cancer
      event id
      notice-dd180377b26bf720
      event date
      2025-06-23
      event kind
      approval-notification
      drug or regimen
      datopotamab deruxtecan-dlnk
      source indication text
      FDA approved datopotamab deruxtecan-dlnk for adults with locally advanced or metastatic epidermal growth factor receptor -mutated non-small cell lung cancer who have received prior EGFR-directed therapy and platinum-based chemotherapy.
      match phrase
      non-small cell lung cancer
      match status
      candidate
      status category
      accelerated
      has date discrepancy
      0
      source collection
      fda-approval-notice
      source key
      fda-29743855ffd67cd9
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2025-07-02 · Zegfrovy (sunvozertinib) · accelerated approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-non-small-cell-lung-cancer
      event id
      fda-1b628574904396b6
      event date
      2025-07-02
      event kind
      accelerated-approval
      drug or regimen
      Zegfrovy (sunvozertinib)
      source indication text
      Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test
      match phrase
      non-small cell lung cancer
      match status
      candidate
      status category
      ongoing
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-079ab36594871b1f41b2
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2025-07-02 · sunvozertinib · approval notification
      release id
      clinical-indications-draft-1
      disease state id
      ds-non-small-cell-lung-cancer
      event id
      notice-c8cbb85cbd2d4981
      event date
      2025-07-02
      event kind
      approval-notification
      drug or regimen
      sunvozertinib
      source indication text
      FDA approved sunvozertinib for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
      match phrase
      non-small cell lung cancer
      match status
      candidate
      status category
      accelerated
      has date discrepancy
      0
      source collection
      fda-approval-notice
      source key
      fda-29a56844a8ee9ae3
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2025-08-08 · Hernexeos (zongertinib) · accelerated approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-non-small-cell-lung-cancer
      event id
      fda-1270b9a947c2ad5f
      event date
      2025-08-08
      event kind
      accelerated-approval
      drug or regimen
      Hernexeos (zongertinib)
      source indication text
      Treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA approved test, and who have received prior systemic therapy
      match phrase
      non-small cell lung cancer
      match status
      candidate
      status category
      ongoing
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-54553a738243b9da33e1
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2025-08-08 · zongertinib · approval notification
      release id
      clinical-indications-draft-1
      disease state id
      ds-non-small-cell-lung-cancer
      event id
      notice-f2609f5cb5cb39a1
      event date
      2025-08-08
      event kind
      approval-notification
      drug or regimen
      zongertinib
      source indication text
      FDA approved zongertinib, a kinase inhibitor, for adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.
      match phrase
      non-small cell lung cancer
      match status
      candidate
      status category
      accelerated
      has date discrepancy
      0
      source collection
      fda-approval-notice
      source key
      fda-7d091a8440ce03e5
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-non-squamous-nsclc-her2-tkd-activating-mutations
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2025-11-19 · Hyrnuo (sevabertinib) · accelerated approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-non-small-cell-lung-cancer
      event id
      fda-2bbdc85ad026f270
      event date
      2025-11-19
      event kind
      accelerated-approval
      drug or regimen
      Hyrnuo (sevabertinib)
      source indication text
      Treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy
      match phrase
      non-small cell lung cancer
      match status
      candidate
      status category
      ongoing
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-daaf01f51985f0cf8178
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2025-11-19 · sevabertinib · approval notification
      release id
      clinical-indications-draft-1
      disease state id
      ds-non-small-cell-lung-cancer
      event id
      notice-56aa7fde42009a56
      event date
      2025-11-19
      event kind
      approval-notification
      drug or regimen
      sevabertinib
      source indication text
      FDA approved sevabertinib, a kinase inhibitor, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.
      match phrase
      non-small cell lung cancer
      match status
      candidate
      status category
      accelerated
      has date discrepancy
      0
      source collection
      fda-approval-notice
      source key
      fda-26f47f4afac6d968
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-non-squamous-non-small-cell-lung-cancer
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2026-02-26 · Hernexeos (zongertinib) · accelerated approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-non-small-cell-lung-cancer
      event id
      fda-e6c39cb199f7bd4f
      event date
      2026-02-26
      event kind
      accelerated-approval
      drug or regimen
      Hernexeos (zongertinib)
      source indication text
      Treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test
      match phrase
      non-small cell lung cancer
      match status
      candidate
      status category
      ongoing
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-acf999b5dcbb789c416e
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2026-02-26 · zongertinib · approval notification
      release id
      clinical-indications-draft-1
      disease state id
      ds-non-small-cell-lung-cancer
      event id
      notice-25bc57241bb0ca37
      event date
      2026-02-26
      event kind
      approval-notification
      drug or regimen
      zongertinib
      source indication text
      FDA approved zongertinib, a kinase inhibitor, for an expanded indication for adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.
      match phrase
      non-small cell lung cancer
      match status
      candidate
      status category
      accelerated
      has date discrepancy
      0
      source collection
      fda-approval-notice
      source key
      fda-3a7f03155778019c
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-unresectable-or-metastatic-non-squamous-non-small-cell
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2026-07-22 · zidesamtinib · approval notification
      release id
      clinical-indications-draft-1
      disease state id
      ds-non-small-cell-lung-cancer
      event id
      notice-210d96cd68e9f2ad
      event date
      2026-07-22
      event kind
      approval-notification
      drug or regimen
      zidesamtinib
      source indication text
      FDA approved zidesamtinib for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer who received at least one prior ROS1 tyrosine kinase inhibitor .
      match phrase
      non-small cell lung cancer
      match status
      candidate
      status category
      Source null
      has date discrepancy
      0
      source collection
      fda-approval-notice
      source key
      fda-e0f74c6ff06b5fd4
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zidesamtinib-ros1-positive-non-small-cell-lung-cancer
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2026-09-09 · Hyrnuo (sevabertinib) · accelerated approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-non-small-cell-lung-cancer
      event id
      fda-1008e60858d8505e
      event date
      2026-09-09
      event kind
      accelerated-approval
      drug or regimen
      Hyrnuo (sevabertinib)
      source indication text
      Treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test
      match phrase
      non-small cell lung cancer
      match status
      candidate
      status category
      ongoing
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-1fbc5cf6f5df6b5af351
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2026-09-09 · sevabertinib · approval notification
      release id
      clinical-indications-draft-1
      disease state id
      ds-non-small-cell-lung-cancer
      event id
      notice-01b9eada22c2ee5e
      event date
      2026-09-09
      event kind
      approval-notification
      drug or regimen
      sevabertinib
      source indication text
      FDA approved sevabertinib, a kinase inhibitor, for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.
      match phrase
      non-small cell lung cancer
      match status
      candidate
      status category
      accelerated
      has date discrepancy
      0
      source collection
      fda-approval-notice
      source key
      fda-31fccf3ff6d99d7d
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-locally-advanced-or-metastatic-non-squamous-non-small
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      Source relationships and population-mapping limitations
      bindings
      1. release id
        clinical-indications-draft-1
        disease state id
        ds-non-small-cell-lung-cancer
        binding id
        ncit-C2926
        source collection
        ncit-concept
        source key
        C2926
        source excerpt
        Source null
        match status
        exact
        match note
        Source null
        recorded at
        2026-09-10T00:00:00Z
      mappings

        Download this complete draft source relationship record →

        Preserved source evidence · Not medical advice