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LUNG: EGFR mutation; "Checkmate 370"

A master protocol of Phase 1/2 studies of nivolumab in advanced NSCLC using nivolumab as maintenance after induction chemotherapy or as first-line treatment alone or in combination with standard of care therapies

Title
Bristol-Myers Squibb CA209-370
Study Title

A master protocol of Phase 1/2 studies of nivolumab in advanced NSCLC using nivolumab as maintenance after induction chemotherapy or as first-line treatment alone or in combination with standard of care therapies

Site Link
Malignancy
Lung, Metastatic Lung Cancer, NSCLC, squamous cell lung cancer, lung adenocarcinoma, non-small cell lung cancer
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
1st line
Investigational Agent
Nivolumab
Drug Class
PD-1 inhibitor
PI
Jason Chandler, MD
Sponsor
Bristol-Myers Squibb
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Locally advanced or metastatic NSCLC
  • For currently open cohort must have EGFR mutation
  • ECOG PS 0-2
  • Tumor tissue available for biomarker evaluation
  • No active CNS involvement
  • No known or active autoimmune disease
  • No known HIV, HBV, HCV
Objective

Primary- PFS and OS: Secondary- DoR, ORR

Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
NSCLC, EGFR mutation
Dosing Frequency
Control Agents
standard therapy or targeted therapy
Study Protocol
Randomized
Yes
X