A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Unresectable Advanced and/or Metastatic Non-Small Cell Lung Cancer

May 24, 2016 updated by: Hoffmann-La Roche

An Open Label Study to Evaluate the Effect of First Line Treatment With Tarceva in Combination With Gemcitabine on Disease Progression in Patients With Unresectable Advanced and/or Metastatic Non-small Cell Lung Cancer

This single arm study will assess the efficacy and safety of erlotinib + gemcitabine in chemotherapy-naive participants with unresectable, advanced and/or metastatic non-small cell lung cancer. Participants will receive erlotinib 150 mg orally (po) daily, in combination with gemcitabine 1000 mg/m^2 intravenously (iv) weekly for 3 weeks of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucuresti, Romania, 022328

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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;
  • advanced and/or metastatic (stage IIIB/IV) unresectable non-small cell lung cancer;
  • no previous systemic chemotherapy, radiation therapy or immunotherapy;
  • Eastern Cooperative Oncology Group (ECOG) >=2.

Exclusion Criteria:

  • prior systemic anti-tumor therapy with human epidermal growth factor receptor 1 (HER1/EGFR) inhibitors;
  • active, non-controlled systemic disease;
  • any other malignancies within 5 years (except for adequately treated cancer in situ of cervix, or basal or squamous cell skin cancer).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erlotinib + Gemcitabine
Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
Drug: Erlotinib
150 mg po daily
Other Names:
  • Tarceva
Drug: Gemcitabine
1000 mg/m^2 iv on days 1, 8, 15 of each 4 week cycle for 6 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Disease Progression
Time Frame: From the time of randomization until disease progression or death (up to 193 weeks)]
Time to disease progression or progression free survival (PFS) 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.
From the time of randomization until disease progression or death (up to 193 weeks)]
Overall Response Rate (ORR)
Time Frame: From the time of randomization until disease progression or death (up to 193 weeks)
Overall response rate was defined as the percentage of participants who had any evidence of confirmed objective complete response (CR) or partial response (PR), per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) and assessed by computed tomography imaging (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
From the time of randomization until disease progression or death (up to 193 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From the time of randomization until death (up to 193 weeks)
Overall survival was defined as the interval between the day of randomization and the date of death from any cause.
From the time of randomization until death (up to 193 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

June 18, 2008

First Submitted That Met QC Criteria

June 18, 2008

First Posted (Estimate)

June 19, 2008

Study Record Updates

Last Update Posted (Estimate)

June 24, 2016

Last Update Submitted That Met QC Criteria

May 24, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML20951
  • 2007-002135-83

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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