LUNG: NSCLC: STAGE III: POST-CHEMO-XRT: COAST

A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Durvalumab (MEDI4736) Alone or in Combination With Novel Agents in Subjects With Locally Advanced, Unresectable (Stage III) Non-small Cell Lung Cancer (COAST)

Title
AstraZeneca D9108C00001 (COAST, Lung)
Study Title

A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Durvalumab (MEDI4736) Alone or in Combination With Novel Agents in Subjects With Locally Advanced, Unresectable (Stage III) Non-small Cell Lung Cancer (COAST)

Site Link
Malignancy
Lung cancer, non-small cell lung cancer, NSCLC
Stage
Disease Setting
Adjuvant/Curative
Line Of Therapy
Post-chemoXRT
Investigational Agent
durvalumab alone or in combination with oleclumab or monalizumab
Drug Class
PD-L1 inhibitor, CD73 antibody, NKG2A antibody
PI
David Portnoy, MD
Sponsor
AstraZeneca
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • NSCLC with locally advanced, unresectable, Stage III disease
  • Must have completed, without progression, definitive chemoradiation within 28 days of randomization
  • ECOG PS 0-1
  • Must have at least one previously irradiated tumor lesion that is measurable at time of study entry
  • No pneumonitis Grade 2 or higher from chemoXRT
  • No tuberculosis, HBV, HCV, or HIV
  • No mixed histology (small-cell and non-small cell)
  • No recent severe cardiac disease
    • No history of other primary malignancy
Objective
  • Primary- ORR
  • Secondary- 
    • Safety
    • Disease Control Rate
    • Duration of Response
    • PFS (overall and at 12-month landmark)
    • PKs and antibodies
Assessment Frequency
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Assessment Frequency 2
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Assessment Frequency Link
Path
adenocarcinoma or squamous cell carcinoma, or large cell carcinoma, or brochoalveolar carcinoma
Dosing Frequency
Control Agents
Study Protocol
Randomized
Yes
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