Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00520676
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The purpose of this study is to compare the combination of pemetrexed and carboplatin with the combination of docetaxel and carboplatin in terms of survival without Grade 3 or 4 toxicity in previously untreated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 260
- Patient with locally advanced or metastatic (Stage IIIB/IV) NCSLC with no prior chemotherapy for advanced disease or molecular target treatment
- Easter Cooperative Oncology Group (ECOG) performance status 0 to 2
- Estimated life expectancy of at least 8 weeks
- Known or suspected brain metastases
- Concurrent administration of any other tumor therapy
- Serious concomitant disorders
- Pregnancy or breast feeding
- Inability or unwillingness to take folic acid or vitamin B12 supplementation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description pemetrexed plus carboplatin pemetrexed Drug: pemetrexed 500 milligrams per square meter (mg/m\^2), intravenous (IV), every (q) 21 days x 6 cycles maximum Drug: carboplatin Area Under the Curve (AUC) 5 milligram\*minute/milliLiter (mg\*min/mL), IV, q 21 days x 6 cycles maximum docetaxel plus carboplatin docetaxel Drug: docetaxel 75 mg/m\^2, IV, q 21 days x 6 cycles maximum Drug: carboplatin AUC 5 mg\*min/mL, IV, q 21 days x 6 cycles maximum pemetrexed plus carboplatin carboplatin Drug: pemetrexed 500 milligrams per square meter (mg/m\^2), intravenous (IV), every (q) 21 days x 6 cycles maximum Drug: carboplatin Area Under the Curve (AUC) 5 milligram\*minute/milliLiter (mg\*min/mL), IV, q 21 days x 6 cycles maximum docetaxel plus carboplatin carboplatin Drug: docetaxel 75 mg/m\^2, IV, q 21 days x 6 cycles maximum Drug: carboplatin AUC 5 mg\*min/mL, IV, q 21 days x 6 cycles maximum
- Primary Outcome Measures
Name Time Method Survival Without Grade 3 or 4 Toxicity Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months). Defined as the time from date of randomization to first date of a Grade 3 or 4 treatment-emergent adverse event (TEAE; as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events \[CTCAE\], version 3.0) or death due to any cause. Grade 3 TEAE: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated. Grade 4 TEAE: Life-threatening consequences; urgent intervention indicated.
Participants who were alive without experiencing Grade 3 or 4 toxicity were censored at the date of last contact.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months). OS is the duration from enrollment to death. For participants who are alive, OS is censored at the last contact.
Progression-free Survival (PFS) Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months). Defined as the time from date of first dose to the first observation of disease progression (PD), or death due to any cause.
Percentage of Participants With Tumor Response (Response Rate) Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months). Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes not meeting above criteria. Response rate (%)=Number of participants with CR+PR/Number of participants analyzed \*100. Disease Control rate=Number of participants with SD+PR+CR/Number of participants analyzed \*100.
Survival Without Clinically Important Grade 3 or 4 Toxicity Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months). Survival without Grade 3 or 4 toxicity is the time from date of randomization to the first date of the following clinically important Grade 3 or 4 TEAEs graded by the Common Terminology Criteria for Adverse Events \[CTCAE\], version 3.0: neutropenia (lasting \>5 days), febrile neutropenia, documented infections related to neutropenia, anemia, thrombocytopenia, fatigue, nausea, vomiting, diarrhea, stomatitis, and neurosensory events; or death due to any cause. Participants who were alive without experiencing Grade 3 or 4 toxicity were censored for this analysis at the date of last contact.
Survival Without Grade 4 Toxicity Baseline to until 218 events (defined as death or Grade 4 toxicity) have been observed (up to 33.3 months). Survival without Grade 4 toxicity is the time from the date of randomization to the first date of a Grade 4 TEAE or death due to any cause. Participants who are alive without experiencing Grade 4 toxicity will be censored for this analysis at the date of last contact.
Number of Participants With Adverse Events (AEs) Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months). Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.
Trial Locations
- Locations (1)
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.
🇨🇳Tao-Yuan, Taiwan