SWOG clinical trial number
S0342
Phase II Selection Design Trial of Concurrent Chemotherapy + Cetuximab vs. Chemotherapy Followed by Cetuximab in Advanced Non-Small Cell Lung Cancer (NSCLC)
100% Accrual
Accrual
100%
Closed
100% Accrual
Accrual
100%
Published
Abbreviated Title
Carbo/Pac + Cetuximab vs. Carbo/Pac followed by Cetuximab/selected IIIB & IV NSCLC
Treatment
Paclitaxel
Carboplatin
Cetuximab
Pts must have histologic or cytologically-confirmed NSCLC, Stage IIIB w/pleural effusion or IV, advanced or recurrent after previous surgery and/or RT; Pts must have measurable disease, evidence of disease on PE, XR, CT or MRI (effusions, ascites or lab parameters alone are not acceptable); Previous surgery is allowed provided at least 2 weeks have elapsed from previous surgery and pt has recovered from all toxicities; ANC >/= 1,500, PLTS >/= 100,000, Hgb >/= 9.0, total bili and SGOT or SGPT and Alk Phos </= 2 X IULN, serum creatinine </= IULN AND calculated or measured creatinine CrCl </= 50 cc/min per formula; Previous RT is allowed provided at least 3 weeks have elapsed since completion and pt has recovered from all toxicities; Pts must not have plans to receive concurrent RT; Measurable or non-measurable disease must be outside previous port; Zubrod PS 0-1; Pts must not have prior malignancy except: treated basal cell or squamous cell skin ca, in situ cervical, Stage I or II ca in complete remission and disease-free from any ca for 5 yrs; Pts must not have received prior chemo or biologic therapy for NSCLC, prior cetuximab, ZD1839 or other investigational agents that target the EGFR pathway; Pts must not have received prior chimerized or murine monoclonal antibody therapy or have documented presence of human anti-mouse antibodies (HAMA); Pts must not have brain mets; Pts must not have significant hx of cardiac disease, uncontrolled HTN, unstable angina or CHF, documented evidence of acute hepatitis or active uncontrolled infection; Pts must be willing to provide prior smoking hx; Pts must not have > Grade 1 symptomatic neuropathy-sensory; Pts must not be pregnant or nursing or of reproductive potential and not agreed to use of effective contraceptive method; Institutions must have IRB approval of S9925 and patients must be offered participation in S9925; Register pts separately to receive institutional credit for specimen submission.
2010
Patient selection for cetuximab in NSCLC: A systematic review of candidate predictive biomarkers
J Harbison;D Horak;S Maier;TJ Lynch;D Gandara;KJ O'Byrne;R Pirker;M Weber;S Khambata-Ford Journal of Clinical Oncology 28:15s (suppl; abstr 7548); ASCO annual meeting; poster
2009
Expression of EGFR protein and markers of epithelial-mesenchymal transformation (DMT) in cetuximab/chemotherapy-treated non-small cell lung cancer (NSCLC)
WA Franklin;DR Gandara;ES Kim;RS Herbst;J Moon;M Redman;C Olsen;FR Hirsch;P Mack;K Kelly Journal of Clinical Oncology 27:15s, abst. #11076
KRAS mutation analysis in cetuximab-treated advanced stage non-small cell lung cancer (NSCLC): SWOG experience with S0342 and S0536
PC Mack;WS Holland;M Redman;P Lara;LJ Snyder;FR Hirsch;WA Franklin;ES Kim;RS Herbst;DR Gandara Journal of Clinical Oncology 27:15s, abst. #8022
Cooperative group research efforts in thoracic malignancies 2009: a review from the 10th Annual International Lung Cancer Congress [PMID19900856]
H Wakelee;BW Loo;KH Kernstine;JB Putnam;MJ Edelman;EE Vokes;HJ Schiller;P Baas;N Saijo;A Adjei;G Goss;H Choy;DR Gandara Clinical Lung Cancer 10(6):395-404
PMC number: n/a (review)
2008
Increased EGFR gene copy number detected by FISH predicts outcome in non-small cell lung cancer patients treated with cetuximab and chemotherapy [PMID18612151;PMC3368372]
FR Hirsch;RS Herbst;C Olsen;K Chansky;JJ Crowley;K Kelly;WA Franklin;PA Bunn Jr;M Varella-Garcia;GR Gandara Journal of Clinical Oncology 26(20)3351-3357
Cooperative group research efforts in lung cancer 2008: focus on advanced-stage non-small-cell lung cancer
H Wakelee;K Kernstine;E Vokes;J Schiller;P Baas;N Saijo;A Adjei;G Gross;L Gaspar;D Gandara;H Choy;JB Putnam Clinical Lung Cancer 9(6):345-351
PMid: PMID19073517 | PMC number: (Reviews are not within the scope of the Public Access)
Summary report 7th annual targeted therapies of the treatment of lung cancer [PMID18449013;PMC3374724]
L Einhorn;P Bonomi;P Bunn;ER Camidge;DP Carbone;H Choy;S Dubinett;D Gandara;L Gaspar;R Govindan;DH Johnson;J Minna;G Scagliotti;H West;R Herbst Journal of Thoracic Oncology 3:545-555
2007
A phase II randomized selection trial evaluating concurrent chemotherapy plus cetuximab or chemotherapy followed by cetuximab in patients with advanced non-small cell lung cancer (NSCLC): final report of SWOG 0342
RS Herbst;K Chansky;K Kelly;JN Atkins;AM Davies;SR Dakhil;KS Albain;ES Kim;JJ Crowley;DR Gandara Proc of the American Society of Clinical Oncology, Journal of Clinical Oncology 25(18S):#7545
2006
Concurrent chemotherapy plus cetuximab or chemotherapy followed by cetuximab in advanced non-small cell lung cancer (NSCLC): a randomized phase II selectional trial SWOG 0342
K Kelly;RS Herbst;JJ Crowley;J McCoy;JN Atkins;PN Lara;SR Dakhil;KS Albain;ES Kim;DR Gandara Proc of the ASCO, Journal of Clinical Oncology 24(18S):#7015
