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)

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