A Study of Cetuximab and Bevacizumab in Combination With Paclitaxel and Carboplatin in Stage IIIb/IV NSCLC

Recruiting at 41 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Eli Lilly and Company

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The primary objective of this study will be to determine the progression free survival of patients with stage IIIb/IV non-small cell lung cancer (NSCLC) treated with dual agent monoclonal antibody therapy consisting of cetuximab and bevacizumab in combination with two different regimens of paclitaxel and carboplatin chemotherapy.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

The patient has histologically or cytologically confirmed non-small cell lung cancer (NSCLC), except squamous cell carcinoma. Mixed tumors will be categorized by the predominant cell type, but the presence of small cell lung cancer elements will make the patient ineligible. Cytologic or histologic elements can be established on metastatic tumor aspirates or biopsy.

The patient has advanced NSCLC (Stage IIIB with malignant pleural effusion or Stage IV or recurrent disease).

Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST).

Treatment Details

Interventions

• Bevacizumab (Monoclonal Antibodies)
• Carboplatin (Alkylating agents)
• Cetuximab (Monoclonal Antibodies)
• Paclitaxel (Anti-tumor antibiotic)

Participant Groups

Group I: Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6) Active Control 4 Interventions

Cycles 1-6: * Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week * Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle * Paclitaxel 200 mg/m² on day 1 of every 3 week cycle * Carboplatin area under curve (AUC=6 min\*mg/mL) on day 1 of every 3 week cycle Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met

Group II: Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3) Active Control 4 Interventions

Cycles 1-6: * Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week * Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle Cycles 1-3: * Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles * Carboplatin AUC=6 min\*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met

Bevacizumab is already approved in Japan, Canada for the following indications:

Approved in Japan as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Approved in Canada as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University