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

Roche

Status and phase: Completed; Phase 2

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: cisplatin; Drug: placebo; Drug: carboplatin; Drug: erlotinib [Tarceva]; Drug: gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01998919

MO18633

Details and patient eligibility

About

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.

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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154 participants in 2 patient groups, including a placebo group

Tarceva + gemcitabine/platinum

Experimental group

Treatment:

Drug: erlotinib [Tarceva]

Drug: gemcitabine

Drug: cisplatin

Drug: carboplatin

Placebo + gemcitabine/platinum

Placebo Comparator group

Treatment:

Drug: gemcitabine

Drug: cisplatin

Drug: carboplatin

Drug: placebo