study of nivolumab (bms-936558) in combination with gemcitabine/cisplatin, pemetrexed/cisplatin, carboplatin/paclitaxel, bevacizumab maintenance, erlotinib, ipilimumab or as monotherapy in subjects with stage iiib/iv non-small cell lung cancer (nsclc) (checkmate 012)

Conditions: Non-small Cell Lung Cancer

Summary: * the study is evaluating the safety and tolerability of nivolumab (bms-936558) when combined with three platinum-based doublet chemotherapy regimens (cisplatin/gemcitabine; cisplatin/pemetrexed; and carboplatin/paclitaxel) in subjects with nsclc. * the study is evaluating the safety and tolerability of nivolumab as maintenance therapy in combination with bevacizumab/avastin that will be given after at least 4 cycles of platinum doublet chemotherapy. * the study is evaluating the safety and tolerability of nivolumab in combination with erlotinib among epidermal growth factor receptor (egfr) mutation positive non-squamous nsclc subjects and as monotherapy in subjects with nsclc. * the study is evaluating the safety and tolerability of nivolumab in combination with ipilimumab in subjects with squamous and non-squamous nsclc. * the study is evaluating the safety and tolerability of nivolumab as switch maintenance therapy in subjects with squamous and non-squamous nsclc. * the study is evaluating the safety and tolerability of nivolumab as monotherapy among subjects with untreated, asymptomatic brain metastases and no evidence of cerebral edema.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * newly diagnosed and confirmed stage iiib/iv nsclc * previously treated nsclc with asymptomatic brain metastases (eligible for arm m) see additional details below * men and women aged ≥18 years * eastern cooperative oncology group (ecog) performance status of 0 to 1 * subject must be chemotherapy naive (except arm d, k, l and m). prior use of epidermal growth factor receptor (egfr) tyrosine kinase inhibitor (tki) is acceptable. for arms d, k, and l, subjects must be non-progressors within 42 days after completion of first-line treatment with ≥4 cycles of platinum doublet chemotherapy with or without bevacizumab. see below for arm m * either a formalin fixed tissue block or a minimum of 10 slides of tumor sample (archived or fresh) must be available for biomarker evaluation (a local pathologist must review for adequacy of sampling) * life expectancy of at least 3 months * prior radiotherapy must have been completed at least 2 weeks prior to study entry for arm m: * no more than 4 brain metastases * each brain metastases ≤3 cm in size * no evidence of cerebral edema * subjects must be free of neurologic symptoms related to metastatic brain lesions and must not have required or received systemic corticosteroids for ≥10 days prior to initiation of study treatment * at least 1 measurable target brain lesion \>0.5 cm and no larger than 3 cm in diameter and/or 2 measurable brain target lesions \>0.3 cm * no prior radiation therapy, surgery, or other local therapy for target brain lesions * must have received at least one prior systemic anticancer therapy for nsclc exclusion criteria: * subjects with symptomatic brain metastases, spinal cord compression, or intractable back pain due to a compressive or destructive mass * subjects who require emergent use of systemic steroids, emergent surgery and/or radiotherapy * any active or history of a known autoimmune disease * subjects with previous malignancies (except non-melanoma skin cancers, in situ bladder cancer, gastric, or colon cancers or cervical cancers/dysplasia, or breast carcinoma in situ) are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period * history of grade ≥2 neuropathy * subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity