A Study of Induction and Maintenance Treatment of Advanced Non-squamous Non-Small Cell Lung Cancer
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00789373
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This study will compare progression-free survival in patients with advanced non-squamous non-small cell lung cancer. Patients who do not progress following 4 cycles of induction treatment with pemetrexed and cisplatin will be randomized 2:1 to receive either maintenance pemetrexed or placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 939
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description pemetrexed + cisplatin followed by pemetrexed Best Supportive Care pemetrexed plus cisplatin followed by pemetrexed plus best supportive care pemetrexed + cisplatin followed by placebo Best Supportive Care pemetrexed plus cisplatin followed by placebo plus best supportive care pemetrexed + cisplatin followed by placebo Placebo pemetrexed plus cisplatin followed by placebo plus best supportive care pemetrexed + cisplatin followed by placebo Pemetrexed pemetrexed plus cisplatin followed by placebo plus best supportive care pemetrexed + cisplatin followed by pemetrexed Pemetrexed pemetrexed plus cisplatin followed by pemetrexed plus best supportive care pemetrexed + cisplatin followed by pemetrexed Cisplatin pemetrexed plus cisplatin followed by pemetrexed plus best supportive care pemetrexed + cisplatin followed by placebo Cisplatin pemetrexed plus cisplatin followed by placebo plus best supportive care
- Primary Outcome Measures
Name Time Method Investigator-assessed Objective Progression-free Survival (PFS) Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months) Investigator-assessed objective PFS was measured from the date of randomization to the first date of objectively determined progressive disease (PD) or death from any cause. For patients not known to have died as of the data cutoff date and who did not have objective PD, PFS was censored at the date of last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With a Non-Serious Adverse Event (AE) During Maintenance Phase Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months) A summary of non-serious AEs is located in the Reported Adverse Event Module.
Independently-assessed Objective Progression-free Survival (PFS) Date of randomization to first date of measured PD or date of death from any cause (up to 19.3 months) To further evaluate the robustness of the PFS analysis, Lilly established an independent review of PFS to assess the potential for investigator bias in the determination of objective PD. PFS was measured from the date of randomization to the first date of objectively determined PD or death. For patients alive as of the data cutoff date and who did not have PD, PFS was censored at the date of the last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.
Percentage of Participants With Serious Adverse Events During Maintenance Phase Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months) A summary of serious adverse events is located in the Reported Adverse Event Module.
Percentage of Participants With Objective Tumor Response (Response Rate) During Maintenance Phase of Study up to Primary Data Cut-Off Baseline to date of measured progressive disease (up to 19.3 months) Analysis for combined phases was not performed since response was calculated separately for each phase of study. Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response(PR)is at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease(PD) is at least a 20% increase in sum of longest diameter of target lesions; Stable Disease(SD)=no change or small changes that do not meet the above criteria for CR, PR, or PD.
Change From Baseline in EuroQol Instrument (EQ-5D) Visual Analog Scale (VAS) Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months) Patients indicate their present health state through completion of the VAS. Possible scores range from 0 (worst imaginable health state) to 100 (best imaginable health state).
Percentage of Participants With Hospitalizations Due to Adverse Events or Requiring Transfusion (Resource Utilization) Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months) Overall Survival (OS) Date of randomization to the date of death from any cause up to 39.5 months OS is the duration from enrollment to death. For patients who are alive, OS is censored at the last contact.
Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months) The EQ-5D is a generic instrument that describes health status in 5 attributes (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) using a three level scale (no problem, some problems, and major problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score range from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).
Percentage of Participants With Independently-Assessed Objective Tumor Response (Response Rate) During Maintenance Phase Up to Primary Data Cut-Off Date of randomization to date of measured PD (up to 19.3 months) Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) is at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=no change or small changes that do not meet the above criteria for CR, PR, or PD. Response Rate = (CR+PR)/Participants in Arm\*100. Disease Control Rate=(CR+PR+SD)/Number of Participants in Arm\*100.
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.
🇬🇧Newcastle, United Kingdom