Study to assess the safety and efficacy of AZD2936 in participants with advanced or metastatic non-small cell lung cancer - ARTEMIDE-01
Study identifier:D7020C00001
ClinicalTrials.gov identifier:NCT04995523
EudraCT identifier:2021-000857-23
CTIS identifier:N/A
Recruiting
Official Title
Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AZD2936 Anti-TIGIT/Anti-PD-1 Antibody in Participants with Advanced or Metastatic Non-small Cell Lung Cancer
Medical condition
Non-Small-Cell Lung Carcinoma
Phase
Phase 1/2
Healthy volunteers
No
Study drug
AZD2936
Sex
All
Estimated Enrollment
192
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 14 Sept 2021
Estimated Primary Completion Date: 07 Dec 2023
Estimated Study Completion Date: 14 Jul 2025
Study design
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Feb 2023 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: Dose Escalation Part A: Checkpoint inhibitor (CPI) experienced NSCLC AZD2936 Intravenous (IV) monotherapy | Drug: AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody Other Name: Not Applicable |
| Experimental: Dose Expansion Part B: CPI experienced NSCLC AZD2936 IV monotherapy | Drug: AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody Other Name: Not Applicable |
| Experimental: Dose Expansion Part C: CPI Naive NSCLC AZD2936 IV monotherapy | Drug: AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody Other Name: Not Applicable |
| Experimental: Dose Expansion Part D: CPI Naive NSCLC AZD2936 IV monotherapy | Drug: AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody Other Name: Not Applicable |
