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DISEASE & TREATMENT SETTING

OPDIVO: resectable Non-small cell lung cancer with EGFR mutations, ALK rearrangements (neoadjuvant) after prior therapy

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

Exact scope

• adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent OPDIVO as adjuvant treatment after surgery.

Broader topic: Non-Small Cell Lung Cancer

Source population
Not part of this definition
Disease extent
Not part of this definition
Treatment line
neoadjuvant
Stage
Not part of this definition
Resectability
resectable
Biomarkers, prior therapy and derivation
molecular
  1. gene
    EGFR
    alteration
    mutations
    status
    present
  2. gene
    ALK
    alteration
    rearrangements
    status
    present
prior therapy
  1. class
    after surgery
    status
    required
derivation status
source-attested
derivation note
Scoped from the FDA approved indication for OPDIVO (product label). Only dimensions stated in that wording are part of this definition.
source wording
• adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent OPDIVO as adjuvant treatment after surgery.

Study evidence for this setting

29 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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NCT00585195 · Source cited / selected · Scope: unclear

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

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NCT00932893 · Source cited / selected · Scope: unclear

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

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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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NCT01625234 · Source cited / selected · Scope: unclear

Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer

6 outcome links · 7 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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NCT01801111 · Source cited / selected · Scope: unclear

A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment

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

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NCT01828099 · Source cited / selected · Scope: unclear

LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer

6 outcome links · 6 safety-group records · 7 quality-of-life measures

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NCT01871805 · Source cited / selected · Scope: unclear

A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)

6 outcome links · 6 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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NCT02094573 · Source cited / selected · Scope: unclear

A Study to Evaluate the Efficacy of Brigatinib (AP26113) in Participants With Anaplastic Lymphoma Kinase (ALK)-Positive, Non-small Cell Lung Cancer (NSCLC) Previously Treated With

6 outcome links · 2 safety-group records · 1 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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NCT02737501 · Source cited / selected · Scope: unclear

ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants

6 outcome links · 3 safety-group records · 1 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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Source relationships and population-mapping limitations
bindings
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      Download this complete draft source relationship record →

      Preserved source evidence · Not medical advice