A Study of Tarceva (Erlotinib) and Gemcitabine in Treatment-Naive Patients With Advanced Non-Small Cell Lung Cancer.

NCT00518011 | Completed Phase 2 Results

• 1 other identifier: ML20063
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 14

Brief Summary

This 2 arm study will assess the efficacy and safety of Tarceva plus gemcitabine, compared with gemcitabine alone, in the treatment of chemotherapy-naive patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg po daily plus gemcitabine on days 1, 8, 15 and every 4 weeks subsequently, or with gemcitabine monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Progression free survival was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first.

  Up to 2 years

Secondary Outcomes (7)

• Objective Response Rate

  Up to 2 years

• Disease Control Rate

  Up to 2 years

• Duration of Response

  Up to 2 years

• Overall Survival

  Up to 2 years

• Mean Change in Pulse Rate From Baseline

  Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)

Study Arms (2)

Erlotinib + Gemcitabine

EXPERIMENTAL

Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles.

Drug: Erlotinib; Drug: Gemcitabine

Gemcitabine

ACTIVE COMPARATOR

Participants received Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles.

Drug: Gemcitabine

Interventions

Erlotinib DRUG

150 mg po daily

Erlotinib + Gemcitabine

Gemcitabine DRUG

As prescribed

Erlotinib + Gemcitabine; Gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients, \>=18 years of age;
• non-small cell lung cancer, stage IIIb (with effusion) or stage IV with measurable disease ;
• ECOG PS 2;
• adequate organ function.

You may not qualify if:

• prior chemotherapy or systemic anti-tumor therapy;
• hypersensitivity to erlotinib;
• any condition contraindicating the use of the study medication and/or impairing the interpretation of results and/or leading to treatment-related complications.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (14)

Unknown Facility

Auchenflower, 4066, Australia

Location

Unknown Facility

Chermside, 4032, Australia

Location

Unknown Facility

Footscray, 3011, Australia

Location

Unknown Facility

Greenslopes, 4120, Australia

Location

Unknown Facility

Lismore, 2480, Australia

Location

Unknown Facility

Melbourne, 3002, Australia

Location

Unknown Facility

Melbourne, 3084, Australia

Location

Unknown Facility

Parkville, 3052, Australia

Location

Unknown Facility

Randwick, 2031, Australia

Location

Unknown Facility

Richmond, 3121, Australia

Location

Unknown Facility

St Leonards, 2065, Australia

Location

Unknown Facility

Sydney, 2139, Australia

Location

Unknown Facility

Wodonga, 3690, Australia

Location

Unknown Facility

Wollongong, 2500, Australia

Location

MeSH Terms

Interventions

Erlotinib Hydrochloride; Gemcitabine

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 616878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2007
• First Posted: August 17, 2007
• Study Start: August 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: May 16, 2016
• Results First Posted: April 1, 2016

Record last verified: 2016-04

Locations

AU (14)