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)

Conditions: Carcinoma, Non-Small-Cell Lung

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.


Eligibility 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

Keywords: lung neoplasms lung cancer non-small cell lung cancer pemetrexed squamous nonsquamous