Overview

This trial is active, not recruiting.

Condition carcinoma, non-small-cell lung
Treatments 1121b (ramucirumab), pemetrexed, carboplatin (auc 6), cisplatin, gemcitabine, carboplatin (auc 5)
Phase phase 2
Sponsor Eli Lilly and Company
Start date September 2010
End date January 2014
Trial size 280 participants
Trial identifier NCT01160744, 13916, 2009-016784-11, CP12-0917, I4T-IE-JVBL

Summary

The purpose of this study is to determine if patients with Stage 4 non-small cell lung cancer have a better outcome when treated with 1121B in combination with pemetrexed + carboplatin/cisplatin or gemcitabine + carboplatin/cisplatin then when treated with pemetrexed + carboplatin/cisplatin or gemcitabine + carboplatin/cisplatin alone.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
1121B + Pemetrexed + Carboplatin (AUC 6) or Cisplatin
1121b (ramucirumab) ramucirumab
10 mg/kg once every 3 weeks beginning Day 1, Cycle 1
pemetrexed ALIMTA®
500 mg/m2 on Day 1 of every 21-day cycle
carboplatin (auc 6)
Day 1 of every 21-day cycle
cisplatin
75 mg/m2 I.V. on Day 1 of each 21-day cycle
(Active Comparator)
Pemetrexed + Carboplatin (AUC 6) or Cisplatin
pemetrexed ALIMTA®
500 mg/m2 on Day 1 of every 21-day cycle
carboplatin (auc 6)
Day 1 of every 21-day cycle
cisplatin
75 mg/m2 I.V. on Day 1 of each 21-day cycle
(Experimental)
1121B + Gemcitabine + Carboplatin (AUC 5) or Cisplatin
1121b (ramucirumab) ramucirumab
10 mg/kg once every 3 weeks beginning Day 1, Cycle 1
cisplatin
75 mg/m2 I.V. on Day 1 of each 21-day cycle
gemcitabine
1000 mg/m2 on Days 1 and 8 of every 21-day cycle
carboplatin (auc 5)
Day 1 of every 21-day cycle
(Active Comparator)
Gemcitabine + Carboplatin (AUC 5) or Cisplatin
cisplatin
75 mg/m2 I.V. on Day 1 of each 21-day cycle
gemcitabine
1000 mg/m2 on Days 1 and 8 of every 21-day cycle
carboplatin (auc 5)
Day 1 of every 21-day cycle

Primary Outcomes

Measure
Progression-free survival (PFS)
time frame: up to 24 months

Secondary Outcomes

Measure
Objective Response Rate (ORR)
time frame: up to 24 months
Overall Survival (OS)
time frame: up to 24 months
Duration of response
time frame: up to 24 months
Summary Listing of Participants Reporting Treatment-Emergent Adverse Events
time frame: up to 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Confirmed Non-small Cell Lung Cancer - Stage IV disease at the time of study entry - Measurable disease at the time of study entry - Resolution to Grade ≤ 1 Adverse Events, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (except alopecia) - Adequate hematologic function, hepatic function, renal function and coagulation function - If sexually active, must be postmenopausal, surgically sterile, or using effective contraception; And agrees to use adequate contraception during the study period and for up to 6 months after the last dose of study medication - Female patients of childbearing potential must have a negative serum pregnancy test Exclusion Criteria: - Has cirrhosis at a level of Child-Pugh B (or worse), or cirrhosis and a history of hepatic encephalopathy, or ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis - Tumor wholly or partially contains small cell lung cancer - Untreated central nervous system (CNS) metastases, eligible if they are clinically stable with regard to neurologic function, off all steroids after cranial irradiation at least 2 weeks prior or after surgical resection performed at least 4 weeks prior to randomization - Concurrent active malignancy other than adequately treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix. A patient with previous history of malignancy other than NSCLC is eligible, provided that he/she has been free of disease for ≥ 3 years - Received prior therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the VEGF or VEGFR - Receiving concurrent treatment with other anticancer therapy - Has received previous chemotherapy for Stage IV NSCLC (patients who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 6 months prior to randomization) - Has radiologically documented evidence of major blood vessel invasion or encasement by cancer - Has undergone chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions) - Ongoing or active infection - History of significant neurological or psychiatric disorders - Experienced clinically relevant coronary artery disease, myocardial infarction within 6 months prior to randomization, uncontrolled congestive heart failure, or symptomatic poorly controlled arrhythmia - Poorly-controlled hypertension - Experienced any serious 3-4 gastrointestinal bleeding within 3 months prior to study entry - Receiving chronic daily treatment with aspirin (> 325 mg/day) or other known inhibitors of platelet function - Serious nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization - Major surgery within 28 days prior the first dose of study medication, or subcutaneous venous access device placement within 7 days prior to randomization - Elective or a planned major surgery - Pregnant or lactating - Any other serious uncontrolled medical disorders or psychological conditions - Allergy / history of hypersensitivity reaction to any of the treatment components - History of drug abuse

Additional Information

Official title An Open-label, Multicenter, Randomized, Phase 2 Study of a Recombinant Human Anti-VEGFR-2 Monoclonal Antibody, IMC-1121B in Combination With Platinum-based Chemotherapy Versus Platinum-based Chemotherapy Alone as First-line Treatment of Patients With Recurrent or Advanced Non-small Cell Lung Cancer (NSCLC)
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.
Location data was received from the National Cancer Institute and was last updated in July 2016.