IMRT 2018

M14-360 Phase 2 Study Design

Concurrent carbo/pac/radiotherapy/ veliparib followed by consolidation carbo/pac/ veliparib

Concurrent carbo/pac/radiotherapy/ veliparib followed by consolidation carbo/pac/ placebo

Stage III NSCLC N=156 (8 countries)

Concurrent carbo/pac/radiotherapy/ placebo followed by consolidation carbo/pac/ placebo

Double-blind Endpoints • 1 ° : PFS •

Major Eligibility:

• Stage III NSCLC (Brain METs excluded) • No prior therapy for current NSCLC • ECOG 0-1 • Measurable disease per RECIST version 1.1

2 ° : OS, ORR, DOR, Safety & Tolerability

3 ° : QoL, ECOG, Biomarkers

•

DMC to assess safety:

• When 45 subjects in Phase 2 have completed CRT, reached an event of disease progression or death, or discontinued the study

Stratification Factors For Randomization: • Tumor volume (≤ 90 versus > 90 cm 3 )

• Smoking history (current smoker versus former smoker versus never smoked)