Chemotherapy for Patients With Non-Small Cell Lung Cancer Who Are Non-Smokers

Eli Lilly and Company70 enrolled

Overview

The purpose of this study is to compare the efficacy and safety of chemotherapy followed sequentially by gefitinib versus chemotherapy alone in the first line treatment of non-small cell lung cancer (NSCLC). This study will be conducted in Asian patients who are classified as 'never smoker' since it is suggested that these patients are more likely to respond favorably to treatment with gefitinib.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-small Cell Lung Cancer

Interventions

PemetrexedDRUG

500 milligrams per meter squared (mg/m2), administered by intravenous (IV) infusion every 21 days for 4 cycles (1-4) or 500 mg/m2, IV, every 21 days until disease progression or unacceptable toxicity.

CisplatinDRUG

75 mg/m2, IV, every 21 days for 4 cycles (1-4) or 75 mg/m2, IV, every 21 days for 4 cycles with optional continuation for 2 additional cycles until disease progression or unacceptable toxicity

GefitinibDRUG

250 mg, administered orally once daily beginning at Cycle 5 until disease progression or unacceptable toxicity

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologic or cytologic diagnosis non-small cell lung cancer (NSCLC) (Stage IIIB or IV) * Have not received any prior chemotherapy, molecular therapy, immunotherapy, biological therapy, or radiotherapy. Exception: palliative radiotherapy that is completed at least 4 weeks prior to study enrolment. * Have 'never smoked' (defined as having smoked \<100 cigarettes during his/her lifetime) * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 Exclusion Criteria: * Concurrent administration of any other tumor therapy * Other co-existing malignancies * Pregnancy or breast feeding * Serious concomitant disorders * Inability or unwillingness to take folic acid or vitamin B12 supplementation

Locations (7)

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.

Fujian, China

Outcomes

Primary Outcomes

Progression-Free Survival (PFS)

Defined as the time from randomization to the first observation of disease progression, or death due to any cause.

Time frame: Baseline to first observation of disease progression or death, 12 weeks up to 31 months

Secondary Outcomes

Number of Participants With Tumor Response

Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes not meeting above criteria. Responder is a participant exhibiting a best overall study response of CR or PR.

Time frame: Baseline to measured response or death, 12 weeks up to 31 months

Duration of Response for Responders

The duration of a complete response (CR; the disappearance of all target lesions) or partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. A responder is a patient exhibiting a best overall study response of CR or PR.

Time frame: Time of response to progressive disease or death, 12 weeks up to 31 months

Overall Survival

Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. Median overall survival could not be estimated as most participants were living at the end of the study. 25 participants from each treatment group were censored. In place of this outcome measure, the percentage of participants who died during the study are provided in the Post-Hoc Analysis Outcome Measure: Percentage of Participants Who Died During the Study.

Time frame: Baseline to date of death from any cause, 12 weeks up to 31 months

Data from ClinicalTrials.gov

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