A Study of Tarceva (Erlotinib) and Standard of Care 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: Alimta or Taxotere

Study type: Interventional

Funder types: Industry

Identifiers

NCT00556322

BO18602

Details and patient eligibility

About

This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva and that of standard of care chemotherapy in patients with advanced, recurrent, or metastatic NSCLC experiencing disease progression after failure of platinum-based chemotherapy.Eligible patients will be randomized to receive either Tarceva 150mg po daily, or comparator (either Alimta 500mg/m2 every 3 weeks, or Taxotere 75mg/m2 every 3 weeks). The anticipated time on study treatment is until disease progression ,and the target sample size is 500+ individuals.

Enrollment: 424 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients >=18 years of age;
• histologically documented, locally advanced or recurrent or metastatic NSCLC;
• measurable disease;
• disease progression during 1-4 cycles of platinum-based chemotherapy.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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424 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: erlotinib [Tarceva]

2

Active Comparator group

Treatment:

Drug: Alimta or Taxotere