A Study of Tarceva (Erlotinib) Following Platinum-Based Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Roche

Status and phase: Completed; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: erlotinib [Tarceva]; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00556712

BO18192

Details and patient eligibility

About

This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva, compared with placebo, following platinum-based chemotherapy in patients with advanced, recurrent, or metastatic NSCLC who have not had disease progression or unacceptable toxicity during chemotherapy. Following 4 cycles of platinum-based chemotherapy, eligible patients will be randomized to receive either Tarceva 150mg po daily, or placebo daily. The anticipated time on study treatment is until disease progression; the target sample size is 500+ individuals.

Enrollment: 889 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients >=18 years of age;
• histologically documented, locally advanced , recurrent or metastatic NSCLC;
• measurable disease;
• no disease progression after 4 cycles of platinum-based chemotherapy.

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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889 participants in 2 patient groups, including a placebo group

Erlotinib

Experimental group

Description:

Participants received erlotinib, 150 milligrams (mg), orally (PO), daily from randomization until progressive disease (PD), death, or unacceptable toxicity.

Treatment:

Drug: erlotinib [Tarceva]

Placebo

Placebo Comparator group

Description:

Participants received a placebo, PO, daily, from randomization until PD, death, or unacceptable toxicity.

Treatment:

Drug: Placebo