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

NCT01998919 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2015-01-13

Study results available
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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

Interventions

DRUG

erlotinib [Tarceva]

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

DRUG

placebo

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

DRUG

gemcitabine

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

DRUG

cisplatin

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

DRUG

carboplatin

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01998919 on ClinicalTrials.gov