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OpenTrials
Completed

NCT Number: NCT00701558

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Metastatic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bucharest, 022328, Romania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Erlotinib

Drug

150 mg po daily

Other names: Tarceva

Gemcitabine

Drug

1000 mg/m^2 iv on days 1, 8, 15 of each 4 week cycle for 6 cycles

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 19, 2008
Registry last updated
Jun 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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