SWOG clinical trial number
S1403
A Randomized Phase II Trial of Afatinib Plus Cetuximab Versus Afatinib Alone In Treatment-Naïve Patients With Advanced, EGFR Mutation Positive Non-Small Lung Cancer (NSCLC)
Closed
Phase
Accrual
29%
Abbreviated Title
Lung Ph II/III Stage IV NSCLC Afatinib+Cetuximab vs Afatinib
Status Notes
This study permanently closed to accrual effective April 23, 2018.
Activated
03/25/2015
Closed
04/23/2018
Participants
ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
Research committees
Lung Cancer
Treatment
Cetuximab
Afatinib
Eligibility Criteria Expand/Collapse
Pts must have Stage IV or recurrent NSCLC with EGFR exon 19 deletion or exon 21 (L858R) substitution mutation. EGFR testing must have been performed using FDA-approved test or in CLIA-certified lab. Pts must have tissue available and agree to have tissue & blood submitted per Sect 15. Tissue must be confirmed by local pathologist to have > 100 viable tumor cells present. Pts enrolled at Repeat Biopsy Study sites must agree to tissue submission from repeat bx at time of progression. No prior systemic anticancer therapy for adv or met dx or adj EGFR-directed therapy. Local therapy allowed if > 7 days since last dose and pt recovered from assoc tox. Disease doc by CT/MRI within 42 days prior to reg. No symptomatic CNS disease and CT/MRI obtained within 42 days prior to reg. No known clinically active interstitial lung disease. ANC >/= 1500, PLT >/= 75,000, HGB >/= 9, bili </= 1.5 x IULN, AST & ALT </= 2.5 x IULN (or 5 w/known liver mets), creatinine </= 1.5 x IULN or calculated >/= 60 obtained within 28 days prior to reg. No significant GI disorders. Able to swallow meds. No hx of clinically relevant cardiovascular abnormalities. If clinically indicated, echo or MUGA performed and cardiac ejection fraction >/=50%. No major surgery within 28 days prior to reg nor during projected course of protocol treatment. No known hx of active Hep B or C nor known HIV.
Publication Information Expand/Collapse
2022
PMid: PMID35713632 | PMC number: PMC9444942
2020
2018
2017
Overview of thoracic oncology trials in cooperative groups around the globe
PMid: PMID27473736 | PMC number: PMC5361177
2015
PMid: PMID26215942 | PMC number: editorial not within scope of Public Access Policy
2014
PMid: PMID24176733 | PMC number: PMC4586161
Other Clinical Trials
SWOG Clinical Trial Number
S2302
PRAGMATICA - LUNG: A PROSPECTIVE RANDOMIZED STUDY OF RAMUCIRUMAB (LY3009806; NSC 749128) PLUS PEMBROLIZUMAB (MK-3475; NSC 776864) VERSUS STANDARD OF CARE FOR PARTICIPANTS PREVIOUSLY TREATED WITH IMMUNOTHERAPY FOR STAGE IV OR RECURRENT NON-SMALL CELL LUNG CANCER
Research Committee(s)
Lung Cancer
Activated
03/06/2023
Accrual
62%
Open
Phase
SWOG Clinical Trial Number
A082002
A Randomized Phase II/III Trial of Modern Immunotherapy Based Systemic Therapy with or Without SBRT for PD-L1-Negative, Advanced Non-Small Cell Lung Cancer
Research Committee(s)
Lung Cancer
Activated
12/21/2021
Open
Phase
SWOG Clinical Trial Number
CTSU/NRG-LU007
RAndomized Phase II/III Trial Of Consolidation Radiation + Immunotherapy for ES-SCLC: RAPTOR Trial
Research Committee(s)
Lung Cancer
Activated
08/17/2020
Open