Status:
ACTIVE_NOT_RECRUITING
A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC
Lead Sponsor:
AstraZeneca
Conditions:
Metastatic Non-Small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18-130 years
Phase:
PHASE1
Brief Summary
This study is designed to determine the efficacy and safety of durvalumab and/or novel oncology therapies, with or without chemotherapy, for first-line Stage IV Non-Small Cell Lung Cancer (NSCLC)
Detailed Description
This is a Phase IB, Open-Label, Multi-Center Study to Determine the Efficacy and Safety of Durvalumab and/or Novel Oncology Therapies, With or Without Chemotherapy, for First-Line Stage IV Non-Small C...
Eligibility Criteria
Inclusion
- Histologically or cytologically documented Stage IV NSCLC not amenable to curative surgery or radiation
- No prior chemotherapy or any other systemic therapy for metastatic NSCLC
- Prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for advanced disease are eligible, if progression has occurred \>12 months from end of last therapy
- Known tumor PD-L1 status
- Tumors that lack activating EGFR mutations and ALK fusions or documented local test result for any other known genomic alteration for which a targeted therapy is approved in first line per local standard of care
- WHO/ECOG status at 0 or 1 at enrollment
- Life expectancy of at least 12 weeks
- Troponin I or T ≤ ULN (per institutional guidelines)
Exclusion
- Active or prior documented autoimmune or inflammatory disorders
- History of active primary immunodeficiency
- Any prior chemotherapy or any other systemic therapy for metastatic NSCLC
- Untreated CNS metastases
Key Trial Info
Start Date :
December 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2026
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT03819465
Start Date
December 27 2018
End Date
March 26 2026
Last Update
October 27 2025
Active Locations (41)
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1
Research Site
Iowa City, Iowa, United States, 52242
2
Research Site
Pittsburgh, Pennsylvania, United States, 15212
3
Research Site
Nashville, Tennessee, United States, 37203
4
Research Site
Salzburg, Austria, 5020