A Study of Pemetrexed and Carboplatin/Cisplatin or Gemcitabine and Carboplatin/Cisplatin With or Without IMC-1121B in Participants Previously Untreated With Recurrent or Advanced Non-Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if participants with Stage IV NSCLC have a better outcome when treated with IMC-1121B in combination with pemetrexed + carboplatin/cisplatin or gemcitabine + carboplatin/cisplatin than when treated with pemetrexed + carboplatin/cisplatin or gemcitabine + carboplatin/cisplatin alone.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Antibodies, Monoclonal; Carboplatin; Cisplatin; Gemcitabine; Pemetrexed; Ramucirumab

Criteria

Inclusion Criteria:

• Confirmed NSCLC

• 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 post-menopausal, 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 participants 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 participant 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 vascular endothelial growth factor (VEGF) or vascular endothelial growth factor receptor (VEGFR)

• Receiving concurrent treatment with other anticancer therapy

• Has received previous chemotherapy for Stage IV NSCLC (participants 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 Grade 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