Trial With Cetuximab in Maintenance Therapy After Platinum Based Chemotherapy in First Line Treatment of Non-small Cell Lung Cancer (NSCLC)

Summary

This open-label, randomized, multinational, non-comparative, phase IIIb trial with 2 parallel groups will screen about 1400 subjects with stage IIIB non-small cell lung cancer (NSCLC) with pleural effusion or stage IV NSCLC. It is expected that of approximately 1200 (85 percent) subjects who will be included, about 1000 will be Caucasian; about 120 Asian, and the remainder (about 80) will be of other ethnic origin (that is neither Caucasian nor Asian). Approximately 480 (40 percent) subjects are expected to be free of progression at the end of combination treatment with cetuximab and platinum-based chemotherapy. These subjects will be eligible for randomization to intravenous cetuximab maintenance therapy with either 500 milligram per square meter (mg/m\^2) every 2 weeks or 250 mg/m\^2 weekly (q1w); about 240 subjects are expected per group.

The trial will be performed in a community practice setting, with approximately 230 centers participating in the trial worldwide (planned countries are Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Mexico, Netherlands, Poland, Portugal, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Turkey, United Kingdom and Venezuela). With noncompetitive enrollment, approximately 4 to 8 subjects are expected to be enrolled at each center. Enrollment in the individual centers is generally limited to a maximum of 8 subjects. If any of these subjects does not receive trial treatment for any reason or discontinue all trial treatment at the first visit, additional subjects may be enrolled until 8 subjects were treated. The primary endpoint of the trial will be overall survival time from inclusion into the trial to death. Additional secondary efficacy endpoints will be time to treatment failure, tumor response, and disease control rate. Other endpoints will include safety and toxicity, compliance with maintenance therapy, subject satisfaction and translational research (TR) (for subjects with tumor samples available).

Conditions

• Non-Small Cell Lung Cancer (NSCLC)

Interventions

DRUG

Cetuximab plus Platinum-based Doublet Chemotherapy

Single first dose of cetuximab 400 mg/m\^2 infusion will be administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m\^2 intravenous infusion over 60 min q1w with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy will be administered as intravenous infusion as per study center included: vinorelbine 25 mg/m\^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m\^2 on D1; or gemcitabine 1250 mg/m\^2 on D1 and D8+cisplatin 75 mg/m\^2 on D1; or gemcitabine 1000 mg/m\^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 milligram\*hour/milliliter (mg\*hr/mL) on D1; or Docetaxel 75 mg/m\^2 on D1+cisplatin 75 mg/m\^2 on D1; or paclitaxel 175 mg/m\^2 on D1+cisplatin 80 mg/m\^2 on D1; or paclitaxel 200 mg/m\^2 on D1+carboplatin at dose to reach AUC6 mg\*hr/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.

DRUG

Cetuximab 500 mg/m^2

Subjects who will be free of disease progression at the end of combination therapy, will enter in the maintenance therapy period. In the maintenance period, subjects will be receive cetuximab 500 mg/m\^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.

DRUG

Cetuximab 250 mg/m^2

Subjects who will free of disease progression at the end of combination therapy, will enter in the maintenance therapy period. In the maintenance period, subjects will be receive cetuximab 250 mg/m\^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany

  lead INDUSTRY

Principal Investigators

• Steffen Heeger, MD MSc · Merck KGaA, Darmstadt, Germany

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-01-31

Primary Completion

2011-12-31

Completion

2013-06-30

Countries

• Germany

Study Locations