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11

Phase 3 CheckMate 026 Study Design:

Nivolumab vs Chemotherapy in First-line NSCLC

Primary endpoint:

PFS (≥5% PD-L1+)

d

Secondary endpoints:

• PFS (≥1% PD-L1+)

d

• OS

• ORR

d

Nivolumab

3 mg/kg IV Q2W

n = 271

Randomize 1:1

Key eligibility criteria:

• Stage IV or recurrent NSCLC

• No prior systemic therapy for

advanced disease

• No

EGFR/ALK

mutations sensitive to

available targeted inhibitor therapy

• ≥1% PD-L1 expression

a

• CNS metastases permitted if

adequately treated at least 2 weeks

prior to randomization

Chemotherapy

(histology dependent)

b

Maximum of 6 cycles

n = 270

Disease progression or

unacceptable toxicity

Disease

progression

Crossover

nivolumab

c

(optional)

Tumor scans Q6W until

wk 48 then Q12W

a

Dako 28-8 validated; archival tumor samples obtained ≤6 months before enrollment were permitted; PD-L1 testing was centralized

b

Squamous: gemcitabine 1250 mg/m

2

+ cisplatin 75 mg/m

2

; gemcitabine 1000 mg/m

2

+ carboplatin AUC 5; paclitaxel 200 mg/m

2

+ carboplatin AUC 6;

Non-squamous: pemetrexed 500 mg/m

2

+ cisplatin 75 mg/m

2

; pemetrexed 500 mg/m

2

+ carboplatin AUC 6; option for pemetrexed maintenance therapy

c

Permitted if crossover eligibility criteria met, including progression confirmed by independent radiology review

d

Tumor response assessment for PFS and ORR per RECIST v1.1 as determined by independent central review

Stratification factors at randomization:

• PD-L1 expression (<5% vs ≥5%)

a

• Histology (squamous vs non-squamous)

ESMO 2016

Socinski et al ESMO 2016