Trial of Carboplatin/Paclitaxel/Cetuximab in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)

Recruiting in Palo Alto (17 mi)

+18 other 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

Trial Summary

What is the purpose of this trial?

The purpose of the study is to determine if the combination of cetuximab, carboplatin and paclitaxel will shrink a specific type of lung cancer known as non-small cell lung cancer (NSCLC). The safety of this combination will also be evaluated.

Research Team

E-mail: ClinicalTrials@ ImClone.com

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

To be eligible for the study, subjects must fulfill all of the following criteria and have a complete signed informed consent form.

Subjects must have signed an approved informed consent.

Subjects with histologically or cytologically documented stage IIIB (supraclavicular lymph node, high neck node, or pleural effusion involvement) or IV NSCLC. Disease must be newly diagnosed or recurrent at least 1 year post adjuvant therapy.

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Treatment Details

Interventions

Carboplatin (Alkylating agents)
Cetuximab (Monoclonal Antibodies)
Paclitaxel (Anti-metabolites)

Participant Groups

2Treatment groups

Active Control

Group I: Arm B (4-week cycle)Active Control3 Interventions

Cetuximab was administered weekly at an initial dose (Week 1) of 400 mg/m2 IV infusion and a weekly maintenance dose of 250 mg/m2 IV infusion. Paclitaxel 100 mg/m2 infused over 180 minutes on Day 1, Day 8 and Day 15 of a 4-week cycle. Carboplatin (AUC = 6) was infused over 30 minutes on Day 1 and subsequently every 4 weeks.

Group II: Arm A (3-week cycle)Active Control3 Interventions

Cetuximab was administered weekly at an initial dose (Week 1) of 400 mg/m2 IV infusion and a weekly maintenance dose of 250 mg/m2 IV infusion. Paclitaxel 225 mg/m2 infused over 180 minutes on Day 1 and subsequently every 3 weeks. Carboplatin (AUC = 6) was infused over 30 minutes on Day 1 and subsequently every 3 weeks.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Paraplatin for: