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Completed

NCT Number: NCT00550173

A Study for Non-Smoker Patients With Nonsquamous Non-Small Cell Lung Cancer

The purpose of this study is to compare the combination of erlotinib and pemetrexed versus either pemetrexed alone and erlotinib alone, in terms of progression-free survival (time until the objective worsening of the disease) in patients who have never smoked and have locally advanced or metastatic Nonsquamous Non-Small Cell Lung Cancer who have failed a first-line chemotherapy treatment.

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Key information

Conditions

Non-Small-Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Barretos, Brazil

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with locally advanced or metastatic nonsquamous non-small cell lung cancer
  • Patients must be non-smokers
  • Patients must have at least one measurable lesion
  • Performance status of 0 to 2 on the Eastern Cooperative Oncology Group Scale
  • Patients must have failed only one prior chemotherapy regimen and must be considered eligible for further chemotherapy following progression of their disease.

Exclusion criteria

  • Patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication
  • Patients who have previously received treatment with drugs against the human epidermal growth factor receptors
  • Patients who have previously received treatment with drugs which have similar targets as Pemetrexed
  • Patients who have any known significant ophthalmologic abnormalities of the surface of the eye
  • Patients who have a history of severe hypersensitivity reaction to erlotinib or pemetrexed

Treatment and study plan

Pemetrexed

Drug

500 milligrams per meter squared (mg/m^2), intravenous (IV), every (q) 21 days until progression or unacceptable toxicity develops

Other names: LY231514, Alimta

Erlotinib

Drug

150 mg, orally, once daily until progression or unacceptable toxicity develops

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: Randomization to measured PD up to 38 months

    PFS is defined as the time from randomization to the first date of progressive disease (PD; either objectively determined or clinical progression) or death from any cause. PD was defined as at least a 20% increase in sum of longest diameter of target lesions as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 guidelines. Time to disease progression was censored at the date of death.

Secondary outcomes

  1. Percentage of Participants With a Tumor Response of Complete Response (CR) or Partial Response (PR) [Tumor Response Rate (TRR)]

    Time frame: Randomization to measured disease progression up to 38 months

    TRR was defined as the number of responders (complete or partial) divided by the number of participants qualified for tumor response, as assessed using the RECIST version 1.0 guideline, multiplied by 100. RECIST guidelines: CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions.

  2. Overall Survival (OS)

    Time frame: Baseline to date of death from any cause up to 45.5 months

    OS is defined as the time from randomization to the date of death from any cause.

  3. Number of Participants With Adverse Events

    Time frame: Randomization up to 39 months

    A summary of serious and all other non-serious adverse events (AEs), which include AEs reported for pharmacological toxicity, is located in the Reported Adverse Event module.

  4. Percentage of Participants With CR, PR, and Stable Disease (SD) - Disease Control Rate (DCR)

    Time frame: Randomization to disease progression up to 38 months

    DCR was defined as the percentage of participants with CR, PR, or SD divided by the number of randomized and treated participants as assessed using the RECIST criteria. CR was defined as the disappearance of all target lesions; PR was defined as 1) at least a 30% decrease in sum of longest diameter of target lesions or 2) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions; PD was defined as at least a 20% increase in sum of longest diameter of target lesions; SD was defined as small changes that did not meet the above criteria.

  5. Time to Worsening of Symptoms (TWS) on Lung Cancer Symptoms Scale (LCSS)

    Time frame: Randomization to first date of worsening of any of 6 LCSS symptom specific items or up to 12.4 months

    TWS assessed using the LCSS a participant rated lung cancer instrument which consisted of 9 disease related symptoms and quality of life (QoL) items, with 6 subscales related to major lung cancer symptoms (appetite, cough, fatigue, dyspnea, hemoptysis, and pain) and 3 summation items related to QoL (activity status, symptomatic distress, and overall QoL). Each item is marked on a visual analog scale (VAS) 0 (low symptoms/QoL items) to 100 (high symptoms/QoL items). The mean of the 6 subscales is used to calculate the average symptom burden index. TWS was measured from the date of study enrollment to the first date of a worsening in any 1 of the 6 LCSS symptom-specific items (as defined by a VAS 15-mm increase from baseline in the patient-reported score for any of these 6 items).

  6. Number of Participants With Mutated or Non-Mutated Epidermal Growth Factor Receptor (EGFR) Genotype Status

    Time frame: Randomization to date of PD or death up to 38 months

    EGFR mutation status was defined as: participants with any mutations detected were categorized as mutated and participants without any mutations detected were categorized as non-mutated.

  7. Probability of OS at 12 Months

    Time frame: Month 12

    OS time is censored at the date of last contact for participants who were still alive or lost to follow-up.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Randomized Phase 2 Study Comparing Erlotinib-Pemetrexed, Pemetrexed Alone, and Erlotinib Alone, as Second-Line Treatment for Non-Smoker Patients With Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Oct 29, 2007
Registry last updated
Feb 13, 2013

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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