SWOG clinical trial number
S0819

A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)

Closed
Phase
Accrual
78%
Published
Abbreviated Title
Phase III Carbo/Taxol/Bevacizumab +/- Cetuximab in Advanced NSCLC
Status Notes
Status Notes: NOTE: The url for ordering specimen kits for this study has changed. Please use the following link: https://ricapps.nationwidechildrens.org/KitManagement
Activated
07/15/2009
Closed
05/01/2015
Participants
NCORP, Members, CTSU Institutions in the United States, Affiliates

Research committees

Lung Cancer

Treatment

Paclitaxel Carboplatin Bevacizumab Cetuximab

Eligibility Criteria Expand/Collapse

Histologically or cytologically proven primary NSCLC (adenocarcinoma, large cell carcinoma, squamous cell carcinoma or unspecified). Disease must be Stage IV. Disease may be either newly diagnosed or recurrent after previous surgery and/or irradiation. Must have measurable or non-measurable disease (see Section 10.1) documented by CT or MRI. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Measurable disease must be assessed within 28 days prior to registration. Non-measurable disease must be assessed within 42 days prior to registration. Must not have brain mets unless: (1) mets have been treated and have remained controlled for at least two weeks following treatment, and (2) patient has no residual neurological dysfuntion off corticosteroids for at least 1 day. Must have a CT or MRI scan of the brain within 42 days prior to registration. Zubrod Performance Status of 0-1. May have received prior radiation therapy provided that patient has recovered from all associated toxicities at the time of registration. May have received prior surgery. Timeframe of surgery depends on whether it is planned for the patient to receive bevacizumab (see Section 5.1g). Must be no anticipation of need for major surgical procedures during protocol treatment. Must not have received prior chemotherapy for any stage non-small cell lung cancer, prior platinum-based chemotherapy for any purpose, cetuximab, gefitinib, erlotinib or other investigational agents that target the EGFR pathway; any prior VEGF-related agents or have received prior chimerized or murine monoclonal antibody (or have documented presence of HAMA). Must have an ANC >/= 1,500/mcl, platelet count of >/= 100,000/mcl and hemoblobin >/=9 g/dL obtained within 14 days prior to registration. Must have within 14 days prior to registration: serum bilirubin </= 2 x IULN, either SGOT or SGPT </= 2 x IULN, serum creatinine </= IULN AND a measured or calculated creatinine clearance >/= 50 mL/min. If patient is planned to receive bevacizumab, UPC ratio obtained within 14 days prior to registration - if UPC ratio > 0.5, 24 hour urine protein must be < 1000 mg. Must be offered participation in the additional integral translational medicine studies as outlined in Section 5.1d. Must not have >/= Grade 2 neuropathy-sensory. Must not have documented evidence of acute hepatitis or an active uncontrolled infection. Must not have history (within past 6 months) of CVA, unstable angina, myocardial infarction; or at the time of registration uncontrolled hypertension, NYHA Class 2 or greater CHF; serious cardiac arrhythmia requiring medication, or clinically significant peripheral vascular disease. Must have no know hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies. Must be willing to provide prior smoking history. No prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years. Must not be pregnant or nursing because of the increased risk of fetal harm including fetal death from the chemotherapeutic agents.

Publication Information Expand/Collapse

2018

A randomized, phase III study of carboplatin/paclitaxel or carboplatin/paclitaxel/ bevacizumab with or without concurrent cetuximab investigating EGFR FISH in patients with advanced non-small cell lung cancer: SWOG S0819

R Herbst;M Redman;ES Kim;E Semrad;L Bazhenova;G Masters;K Oettel;P Guaglianone;C Reynolds;A Karnad;S Arnold;M Varella-Garcia;J Moon;PC Mack;C Blanke;F Hirsch;K Kelly;D Gandara Lancet Oncology Jan;19(1):101-114. Epub 2017 Nov 20.Nov 20. [Epub ahead of print]

PMid: PMID9169877 | PMC number: PMC5847342

2016

Comorbidities and Risk of Chemotherapy-Induced Peripheral Neuropathy Among Participants 65 Years or Older in Southwest Oncology Group Clinical Trials

D Hershman;C Till;J Wright;D Awad;S Ramsey;W Barlow;L Minasian;J Unger Journal of Clinical Oncology Sep 1;34(25):3014-3022; 2016 Jun 20 [Epub ahead of print]

PMid: PMID27325863 | PMC number: PMC5012713

Outcomes for patients treated with or without bevacizumab on SWOG S0819: a randomized, phase III study comparing carboplatin/paclitaxel or carboplatin/paclitaxel/bevacizumab with or without concurrent cetuximab in patients with advanced non-small cell lung cancer (NSCLC)

T Semrad;M Redman;R Herbst;ES Kim;L Bazhenova;G Masters;K Oettel;P Guaglianone;C Reynolds;A Karnad;S Arnold;M Varella Garcia;J Moon;P Mack;C Blanke;FR Hirsch;K Kelly;D Gandara Journal of Clinical Oncology 34, 2016 (supp;abstr 9082);American Society of Clinical Oncology Annual Meeting (June 3-7, 2016, Chicago, IL), poster session

Biomarker-enriched efficacy of cetuximab-based therapy: squamous subset analysis from SWOG S0819, a phase III trial of chemotherapy with or without cetuximab in advanced NSCLC

F Hirsch;M Redman;R Herbst;E Kim;T Semrad;L Bazhenova;G Masters;K Oettel;P Guaglianone;C Reynolds;A Karnad;S Arnold;M Varella Garcia;J Moon;P Mack;C Blanke;K Kelly;D Gandara Journal of Clinical Oncology 34, 2016 (suppl; abstr 9090); American Society of Clinical Oncology Annual Meeting (June 3-7, 2016, Chicago, IL), poster session

Comorbidities and risk of chemotherapy induced peripheral neuropathy among participants in SWOG clinical trials

DL Hershman;C Till;JD Wright;D Awad;S Ramsey;W Barlow;L Minasian;J Unger Journal of Clinical Oncology 34, 2016 (suppl; abstr 10001); American Society of Clinical Oncology Annual Meeting (June 3-7, 2016, Chicago, IL), oral presentation

Role of KRAS mutation status in NSCLC patients treated on S0819, a phase II trial of chemotherapy with or without cetuximab

P Mack;J Moon;R Herbst;ES Kim;T Semrad;M Redman;RA Tsai;L Solis;J Gregg;S Hatcher;M Varella Garcia;F Hirsch;C Blanke;K Kelly;D Gandara World Conference on Lung Cancer (Dec 4-7, 2016,Vienna, Austria); poster

2015

A randomized, phase III study comparing carboplatin/paclitaxel or carboplatin/ paclitaxel/bevacizumab with or without concurrent cetuximab in patients with advanced non-small cell lung cancer (NSCLC): SWOG S0819

RS Herbst;M Redman;ES Kim;TJ Semrad;L Bazhenova;G Masters;K Oettel;P Guaglianone;C Reynolds;A Karnad;SM Arnold;M Varella-Garcia;J Moon;CD Blanke;F Hirsch;DR Gandara Journal of Thoracic Oncology Volume 10, Number 9, Supplement 2, September 2015; World Conference on Lung Cancer (WCLC), (September 6-9, 2015, Denver, CO), oral

2012

Design of a phase III clinical trial with prospective biomarker validation: SWOG S0819

M Redman;J Crowley;R Herbst;F Hirsch;D Gandara Clinical Cancer Research 18(15):4004-4012

PMid: PMID:22592956 | PMC number: PMC3409929

Algorithm for codevelopment of new drug-predictive biomarker combinations: accounting for inter- and intrapatient tumor heterogeneity

DR Gandara;T Li;PN Lara, Jr;PC Mack;K Kelly;S Miyamoto;N Goodwin;L Beckett;M Redman Clinical Lung Cancer 13(5):321-325

PMid: PMID2267743 | PMC number: Reviews not within the scope of the Public Access Policy

2009

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)