A Study Comparing of Two Different Chemotherapy Regimens, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Drug: Best Supportive Care
- Registration Number
- NCT00606021
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This is a multicenter, open-label, randomized, two-arm Phase 2 study comparing pemetrexed plus best supportive care with best supportive care alone as maintenance therapy following first-line treatment with a pemetrexed-cisplatin combination in patients with advanced non-squamous non-small cell lung cancer.
A total of approximately 100 patients are planned to be enrolled, and following completion of four cycles of pemetrexed-cisplatin (Induction Phase) those patients in which disease progression has not occurred will be randomized in a 2:1 ratio to one of two treatment arms (Maintenance Phase): Arm A (pemetrexed plus best supportive care) or Arm B (best supportive care alone).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A: Pemetrexed + Best Supportive Care pemetrexed Pemetrexed: 500 milligrams per square meter (mg/m²) , intravenous (IV), Day 1 of each 21-day cycle for 6 cycles Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician. A: Pemetrexed + Best Supportive Care Best Supportive Care Pemetrexed: 500 milligrams per square meter (mg/m²) , intravenous (IV), Day 1 of each 21-day cycle for 6 cycles Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician. B: Best Supportive Care Best Supportive Care Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
- Primary Outcome Measures
Name Time Method Progression Free Survival During Maintenance Phase Randomization to progression of disease (PD) or date of death from any cause up to 30.9 months Progression free survival is defined as the time from randomization until the date of progression of disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in maintenance phase uses the last lesion assessment prior to randomization as the baseline assessment.
- Secondary Outcome Measures
Name Time Method Progression Free Survival During Overall Period (Induction Phase [IP] + Maintenance Phase [MP]) First dose of study drug during IP to PD or date of death from any cause up to 33.6 months Progression-free survival in overall period is defined as the time from the date of first dose of study drug during IP until the date of PD or death from any cause. PD was determined using RECIST criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in overall period uses the screening lesion assessment prior to the induction phase as the baseline assessment.
Overall Survival During Maintenance Phase Randomization to PD or date of death from any cause up to 31.3 months Overall survival in maintenance phase is defined as the time from randomization to death. Participants who were alive were censored at the last contact.
Overall Survival During Overall Period (IP + MP) First dose of study drug during IP to PD or date of death from any cause up to 34.1 months Overall survival in overall period is defined as the time from first dose of study drug during IP to death. Participants who were alive were censored at the last contact.
Number of Participants With Adverse Events (AEs) During Overall Period First dose of study drug during IP through overall study completion (up to 34.3) months The list of serious adverse events (SAEs) and other non-serious adverse events (AEs) are in Adverse Events Section.
Tumor Response Rate and Disease Control Rate After Induction Phase (IP) Randomization to measured PD up to 31.4 months Tumor response rate (%) is the number of responders (participants with best response of CR or PR) divided by the number of participants qualified for tumor response according to RECIST criteria multiplied by 100. Disease control rate is percentage of participants with a best response of stable disease \[SD\], PR, or CR. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; PD is≥20% increase in sum of longest diameter of target lesions. SD= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
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.
🇸🇦Riyadh, Saudi Arabia