Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatments pemetrexed, cisplatin, placebo, best supportive care
Phase phase 3
Sponsor Eli Lilly and Company
Start date November 2008
End date June 2010
Trial size 939 participants
Trial identifier NCT00789373, 12560, CTRI/2009/091/000113, H3E-EW-S124

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
pemetrexed plus cisplatin followed by pemetrexed plus best supportive care
pemetrexed Alimta
Induction therapy: 500 mg/m^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles
cisplatin
Induction therapy: Cisplatin: 75 mg/m^2, IV, on Day 1 of each 21-day cycle for 4 cycles
pemetrexed Alimta
Maintenance therapy: 500 mg/m^2, IV, on Day 1 of each 21-day cycle until progressive disease or treatment discontinuation.
best supportive care
Best Supportive Care is treatment given with the intent to maximize quality of life. Best Supportive Care excludes any treatment in which the goal is to cure or slow the progression of the study disease. Patients will receive Best Supportive Care as judged by their treating physician. Those therapies considered acceptable include, but are not limited to, palliative radiation to extrathoracic structures, antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support (enteral or parenteral).
(Placebo Comparator)
pemetrexed plus cisplatin followed by placebo plus best supportive care
pemetrexed Alimta
Induction therapy: 500 mg/m^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles
cisplatin
Induction therapy: Cisplatin: 75 mg/m^2, IV, on Day 1 of each 21-day cycle for 4 cycles
placebo
Maintenance therapy: Normal saline (0.9% sodium chloride) administered IV on Day 1 every 21-day cycle until progressive disease or treatment discontinuation
best supportive care
Best Supportive Care is treatment given with the intent to maximize quality of life. Best Supportive Care excludes any treatment in which the goal is to cure or slow the progression of the study disease. Patients will receive Best Supportive Care as judged by their treating physician. Those therapies considered acceptable include, but are not limited to, palliative radiation to extrathoracic structures, antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support (enteral or parenteral).

Primary Outcomes

Measure
Investigator-assessed Objective Progression-free Survival (PFS)
time frame: Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months)

Secondary Outcomes

Measure
Independently-assessed Objective Progression-free Survival (PFS)
time frame: Date of randomization to first date of measured PD or date of death from any cause (up to 19.3 months)
Overall Survival (OS)
time frame: Date of randomization to the date of death from any cause up to 39.5 months
Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score
time frame: Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)
Change From Baseline in EuroQol Instrument (EQ-5D) Visual Analog Scale (VAS)
time frame: Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)
Percentage of Participants With Hospitalizations Due to Adverse Events or Requiring Transfusion (Resource Utilization)
time frame: Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)
Percentage of Participants With a Non-Serious Adverse Event (AE) During Maintenance Phase
time frame: Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months)
Percentage of Participants With Serious Adverse Events During Maintenance Phase
time frame: Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months)
Percentage of Participants With Objective Tumor Response (Response Rate) During Maintenance Phase of Study up to Primary Data Cut-Off
time frame: Baseline to date of measured progressive disease (up to 19.3 months)
Percentage of Participants With Independently-Assessed Objective Tumor Response (Response Rate) During Maintenance Phase Up to Primary Data Cut-Off
time frame: Date of randomization to date of measured PD (up to 19.3 months)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria for the Induction Phase: - You must sign an informed consent document for clinical research. - You must have Stage IIIB or IV nonsquamous Non-Small Cell Lung Cancer. - You must at least be able to be physically mobile, take care of yourself, and must be up and about and able to perform light activities such as light housework or office work. - You are allowed to have had prior radiation therapy as long as it was not to more than 25% of the bone marrow and did not include the whole pelvis. Thoracic radiation must be completed more than 30 days before the study. You must be recovered from the toxic effects (except hair loss). - You must have at least 1 measurable tumor lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated by computed tomography (CT) Scan. - Your test results assessing the function of your blood forming tissue, kidneys, and liver must be satisfactory. - You must be 18 years of age or older. - Women must be sterile, postmenopausal or on contraception and men must be on contraception or sterile (e.g. post-vasectomy). Exclusion Criteria for the Induction Phase: - You cannot have squamous cell and/or mixed small cell, non-small cell lung cancer - You cannot have received other investigational drugs within the last 30 days of entering the trial. - You cannot have previously completed or withdrawn from this study or any other study investigating pemetrexed. - You cannot have other serious on-going illnesses including active infections. - You cannot have a serious cardiac condition, such as a heart attack, angina, or heart disease within 6 months of entering the trial. - You cannot have had another form of cancer other than superficial basal cell and superficial squamous (skin) cell cancer, or carcinoma in situ of the cervix within the last 5 years. Patients with a history of low-grade (Gleason score less than or equal to 6) localized prostate cancer will be eligible even if diagnosed less than 5 years ago. - You cannot have known central nervous system (CNS) metastases, other than treated, stable brain metastasis. - You cannot be receiving nor have received any prior systemic anticancer therapy for lung cancer (including chemotherapy given after surgery in early-stage treatment). - You cannot have clinically significant third-space fluid collections (e.g. ascites or pleural effusions that cannot be controlled by drainage or other procedures). - You cannot have received a recent (within 30 days) or are receiving a yellow fever vaccination. - You are unable to stop taking more than 1.3 grams of aspirin on a daily basis or other non-steroidal anti-inflammatory drugs (NSAIDs). - You are unable or unwilling to take folic acid, injections of vitamin B12, or corticosteroids. - You cannot be pregnant or breastfeeding. Inclusion criteria at Randomization for the Maintenance Phase: - You must at least be able to be physically mobile, take care of yourself, and must be up and about and able to perform light activities such as light housework or office work. - You must have documented radiographic evidence of a tumor response of complete response (CR), partial response (PR), or stable disease (SD) according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Tumor assessment must occur between Cycle 4 (Day 1) of induction therapy and the date of randomization. This response does not have to be confirmed in order for the patient to be randomized to the maintenance phase.

Additional Information

Official title A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Immediately Following Induction Treatment With Pemetrexed + Cisplatin for Advanced Non-squamous Non-Small Cell Lung Cancer.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.