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

A Randomised, Placebo-controlled, Double-blind Phase II of Sequential Administration of Tarceva (Erlotinib) or Placebo in Combination With Gemcitabine/Platinum as First-line Treatment in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC).

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.

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: erlotinib [Tarceva]; Drug: gemcitabine; Drug: cisplatin; Drug: carboplatin; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Campbelltown, Australia, 2560
  • Camperdown, Australia, 2050
  • Liverpool, Australia, 2170
• China
  • Guangzhou, China, 510060
  • Guangzhou, China, 510080
  • Shanghai, China, 200433
  • Shanghai, China, 200030
• Hong Kong
  • Hong Kong, Hong Kong
• Indonesia
  • Jakarta, Indonesia, 10430
  • Jakarta, Indonesia, 10410
  • Jogjakarta, Indonesia, 55284
  • Semarang, Indonesia, 50136
• Korea, Republic of
  • Kyunggi-do, Korea, Republic of, 411-769
• Philippines
  • Manila, Philippines, 1000
  • Metro Manila, Philippines, 1502
• Taiwan
  • Taipei, Taiwan
  • Taipei, Taiwan, 100
• Thailand
  • Bangkok, Thailand, 10400
  • Bangkok, Thailand, 10700

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tarceva + gemcitabine/platinum	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: 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
Placebo Comparator: Placebo + gemcitabine/platinum	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; Drug: placebo; orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by daily oral application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)	Non-progression defined as documented best overall tumor response of complete response (CR), partial response (PR), or stable disease (SD; where SD was maintained for greater than [>]8 weeks) per RECIST. Investigator's assessment of response used in all analyses. CR equals (=)disappearance of all target lesions; PR=at least a 30 percent (%) decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference smallest sum LD since treatment started.	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Non-Progression at Week 16 as Assessed by RECIST	Non-progression defined as documented best overall tumor response of CR, PR, or SD (where SD was maintained for >16 weeks) per RECIST.	Week 16
Percentage of Participants With Confirmed CR or PR as Assessed by RECIST	CR=disappearance of all target lesions; PR=at least a 30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD.	Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
Duration of Response	Duration of Response was defined similarly for complete responders and partial responders. CR was defined as the date CR was first recorded to the date on which PD was first noted or date of death. PR was defined as the date the first PR was recorded to the date of the first observation of PD or date of death.	Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-study Phases
Time to Progression	Time to progression was defined as the interval between the day of randomization and the first documentation of PD. Participants who were withdrawn from the study without documented progression and for whom there exists CRF evidence that evaluations have been made, were censored at 1) the date of the last tumor assessment, 2) last date in the drug log, or 3) last date of follow-up when the participant was known to be progression free, whichever was last. Participants without post-baseline tumor assessments but known to be alive were censored at the time of randomization.	Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
Progression-Free Survival (PFS)	PFS was defined as the interval between the day of randomization and the date of first documentation of progressive disease or date of death, whichever came first.	Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
Overall Survival	Overall Survival (OS) was defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment.	Date of randomization until date of death or date of last follow-up assessment

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: November 25, 2013
• First Submitted That Met QC Criteria: November 25, 2013
• First Posted (Estimate): December 2, 2013

Study Record Updates

• Last Update Posted (Estimate): January 13, 2015
• Last Update Submitted That Met QC Criteria: December 12, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protein Kinase Inhibitors; Gemcitabine; Carboplatin; Erlotinib Hydrochloride
• Other Study ID Numbers: MO18633