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DISEASE & TREATMENT SETTING

Gilotrif: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration, EGFR mutations (first-line) after prior therapy

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

Exact scope

1 INDICATIONS AND USAGE GILOTRIF is a kinase inhibitor indicated for: First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test ( 1.1 ) Limitations of Use : Safety and efficacy of GILOTRIF were not established in patients whose tumors have resistant EGFR mutations ( 1.1 ) Treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy ( 1.2 )

Broader topic: Non-Small Cell Lung Cancer

Source population
Not part of this definition
Disease extent
metastatic
Treatment line
first-line
Stage
Not part of this definition
Resectability
Not part of this definition
Biomarkers, prior therapy and derivation
molecular
  1. gene
    EGFR
    alteration
    stated without a specific alteration
    status
    present
  2. gene
    EGFR
    alteration
    mutations
    status
    present
prior therapy
  1. class
    after platinum-based chemotherapy ( 1
    status
    required
derivation status
source-attested
derivation note
Scoped from the FDA approved indication for Gilotrif (product label). Only dimensions stated in that wording are part of this definition.
source wording
1 INDICATIONS AND USAGE GILOTRIF is a kinase inhibitor indicated for: First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test ( 1.1 ) Limitations of Use : Safety and efficacy of GILOTRIF were not established in patients whose tumors have resistant EGFR mutations ( 1.1 ) Treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy ( 1.2 )

Study evidence for this setting

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

NCT00446225 · Source cited / selected · Scope: unclear

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

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NCT00525148 · Source cited / selected · Scope: unclear

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

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NCT00949650 · Source cited / selected · Scope: unclear

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

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NCT01121393 · Source cited / selected · Scope: unclear

BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC)

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

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NCT01451632 · Registry condition search · Scope: unclear

A Safety Study of MM-121 With Cetuximab and Irinotecan in Patients With Advanced Cancers

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

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NCT01647711 · Registry condition search · Scope: unclear

A Study of Intermittent, High-dose Afatinib to Determine the Maximal Tolerated Dose and Assess Activity of This Dose Against Non-small Cell Lung Cancer With T790M Mutations

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

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NCT01774721 · Source cited / selected · Scope: unclear

ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC.

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

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NCT02094261 · Source cited / selected · Scope: unclear

Phase II AZD9291 Open Label Study in NSCLC After Previous EGFR TKI Therapy in EGFR and T790M Mutation Positive Tumours

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

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NCT02411448 · Source cited / selected · Scope: unclear

A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)

6 outcome links · 3 safety-group records · 4 quality-of-life measures

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NCT02414139 · Source cited / selected · Scope: unclear

Study of Oral cMET Inhibitor INC280 in Patients With EGFR Wild-type (wt), Advanced Non-small Cell Lung Cancer (NSCLC) (Geometry Mono-1)

6 outcome links · 26 safety-group records · 0 quality-of-life measures

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NCT02489903 · Registry condition search · Scope: unclear

RRx-001 in Lung Cancer, Ovarian Cancer and Neuroendocrine Tumors Prior to Re-administration of Platinum Based Doublet Regimens (QUADRUPLE THREAT)

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

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NCT02770014 · Registry condition search · Scope: unclear

Rapid Plasma Genotyping For Early Initiation Of Erlotinib In EGFR Mutant Lung Cancer

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

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NCT03974022 · Source cited / selected · Scope: unclear

Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)

6 outcome links · 15 safety-group records · 0 quality-of-life measures

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NCT04035486 · Source cited / selected · Scope: unclear

A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)

6 outcome links · 4 safety-group records · 8 quality-of-life measures

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NCT04487080 · Source cited / selected · Scope: unclear

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

6 outcome links · 3 safety-group records · 1 quality-of-life measures

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NCT04538664 · Source cited / selected · Scope: unclear

A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer

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

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NCT04988295 · Source cited / selected · Scope: unclear

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (E

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

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NCT05388669 · Source cited / selected · Scope: unclear

A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastati

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

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Source relationships and population-mapping limitations
bindings
    mappings

      Download this complete draft source relationship record →

      Preserved source evidence · Not medical advice