Overview

This trial is active, not recruiting.

Condition non small cell lung cancer
Treatments pemetrexed, cisplatin, gefitinib
Phase phase 3
Target EGFR
Sponsor Eli Lilly and Company
Start date November 2009
End date April 2013
Trial size 236 participants
Trial identifier NCT01017874, 13021, H3E-CR-S131

Summary

The purpose of this study is to compare two different approaches to treating non-small cell lung cancer (NSCLC) in East Asian never-smoker participants. Half of the participants will receive chemotherapy (pemetrexed/cisplatin) followed by an oral anti-cancer agent (gefitinib) and the other half of the participants will receive only the oral anti-cancer agent (gefitinib).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
pemetrexed Alimta
500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles.
cisplatin
75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles
gefitinib
250 milligrams (mg) administered orally once a day, every day of 21-day cycle, for maintenance in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy
(Active Comparator)
gefitinib
250 milligrams (mg) administered orally once a day, every day of 21-day cycles administered as a monotherapy

Primary Outcomes

Measure
Progression Free Survival (PFS)
time frame: Randomization to the first date of measured PD or death up to 37.32 months

Secondary Outcomes

Measure
Overall Survival (OS)
time frame: Randomization to date of death from any cause
Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Tumor Response Rate (TRR)]
time frame: Randomization up to 37.52 months
Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [Disease Control Rate (DCR)]
time frame: Randomization up to 37.52 months
Time to Progressive Disease (TtPD)
time frame: Randomization to the first date of measured PD up to 37.32 months
Duration of Tumor Response
time frame: Date of initial response to the date of measured PD or death up to 34.43 months
Time to Worsening of Health-Related Quality of Life (TWQ) Using the Participant-Rated Lung Cancer Symptom Scale (LCSS)
time frame: Every cycle while on-study therapy and at 3 months post last dose

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histological diagnosis of NSCLC with locally advanced or metastatic disease that is of non-squamous histology. - Participants must be "light ex-smokers" or "never-smokers". - "Light ex-smokers" defined as having ceased smoking for greater than or equal to 5 years and not to have exceeded 10 pack-years. - "Never-smokers" are defined as having smoked <100 cigarettes or equivalent during his/her lifetime. - Participants must be of East Asian ethnicity. - No prior systemic therapy for lung cancer. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: - Presence of clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry. - Any evidence of clinically active interstitial lung disease. Asymptomatic participants with chronic, stable, radiographic changes are eligible. - Participants whose Epidermal Growth Factor Receptor (EGFR) mutation status is known prior to study entry will be excluded. Participants in which EGFR mutation testing has not been performed, or whose EGFR mutation status is unknown or inconclusive at study entry are eligible.

Additional Information

Official title A Randomized Ph 3 Study Comparing First-Line Pemetrexed/Cisplatin Followed by Gefitinib With Gefitinib Alone in East Asian Never Smoker or Light Ex-Smoker Patients With Locally Advanced or Metastatic Nonsquamous NSCLC
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.