A Study of Tarceva (Erlotinib) in Combination With Platinum Based Chemotherapy in Patients With Non-Small Cell Lung Cancer.

NCT ID: NCT01998919

Last Updated: 2015-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2011-11-30

Brief Summary

This study will evaluate the efficacy and safety of sequential administration of Tarceva and gemcitabine/platinum chemotherapy in patients with stage IIIb/IV non-small cell lung cancer. Patients will be randomized to receive Tarceva (150 mg po) or placebo on days 15-28 of a 4 week cycle of intravenous platinum-based chemotherapy, for a total of 6 cycles. The anticipated time on study treatment is until disease progression or unacceptable toxicity.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tarceva + gemcitabine/platinum

Group Type: EXPERIMENTAL

erlotinib [Tarceva]

Intervention Type: DRUG

150 mg orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by 150 mg orally daily

gemcitabine

Intervention Type: DRUG

1250 mg/m2 iv Days 1 and 8 of each 4-week cycle, 6 cycles

cisplatin

Intervention Type: DRUG

75 mg/m2 iv Day 1 of each 4.wek cycle, 6 cycles; or carboplatin

carboplatin

Intervention Type: DRUG

5 x AUC iv Day 1 of each 4.week cycle, 6 cycles; or cisplatin

Placebo + gemcitabine/platinum

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by daily oral application

gemcitabine

Intervention Type: DRUG

1250 mg/m2 iv Days 1 and 8 of each 4-week cycle, 6 cycles

cisplatin

Intervention Type: DRUG

75 mg/m2 iv Day 1 of each 4.wek cycle, 6 cycles; or carboplatin

carboplatin

Intervention Type: DRUG

5 x AUC iv Day 1 of each 4.week cycle, 6 cycles; or cisplatin

Interventions

erlotinib [Tarceva]

150 mg orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by 150 mg orally daily

Intervention Type: DRUG

placebo

orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by daily oral application

Intervention Type: DRUG

gemcitabine

1250 mg/m2 iv Days 1 and 8 of each 4-week cycle, 6 cycles

Intervention Type: DRUG

cisplatin

75 mg/m2 iv Day 1 of each 4.wek cycle, 6 cycles; or carboplatin

Intervention Type: DRUG

carboplatin

5 x AUC iv Day 1 of each 4.week cycle, 6 cycles; or cisplatin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• adult patients, >=18 years of age;
• histologically documented advanced or recurrent stage IIIB or IV non-small cell lung cancer;
• measurable disease;
• no previous chemotherapy for non-small cell lung cancer.

Exclusion Criteria

• unstable systemic disease;
• any other malignancies in the last 5 years.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_CHAIR

Hoffmann-La Roche

Locations

Campbelltown, , Australia

Camperdown, , Australia

Liverpool, , Australia

Guangzhou, , China

Guangzhou, , China

Shanghai, , China

Shanghai, , China

Hong Kong, , Hong Kong

Jakarta, , Indonesia

Jakarta, , Indonesia

Semarang, , Indonesia

Yogyakarta, , Indonesia

Manila, , Philippines

Metro Manila, , Philippines

Kyunggi-do, , South Korea

Taipei, , Taiwan

Taipei, , Taiwan

Bangkok, , Thailand

Bangkok, , Thailand

Countries

Australia; China; Hong Kong; Indonesia; Philippines; South Korea; Taiwan; Thailand

Other Identifiers

MO18633

Identifier Type: -

Identifier Source: org_study_id