Study of Navtemadlin Plus Pembrolizumab as Maintenance Therapy in Locally Advanced and Metastatic Non-Small Cell Lung Cancer
NCT05705466 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL
Last updated 2024-03-22
Summary
This study evaluates Navtemadlin (KRT-232) in combination with Pembrolizumab as a maintenance therapy in patients with locally advanced and metastatic non small cell lung cancer.
Conditions
- Non Small Cell Lung Cancer
Interventions
- DRUG
-
Navtemadlin
Navtemadlin is an experimental MDM2 anticancer drug taken by mouth.
- DRUG
-
Navtemadlin Placebo
Navtemadlin placebo is a placebo that is the same in appearance to navtemadlin drug taken by mouth.
- DRUG
-
Pembrolizumab is a humanized antibody used in cancer immunotherapy that will be administered intravenously
Sponsors & Collaborators
-
Kartos Therapeutics, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-30
- Primary Completion
- 2025-06-30
- Completion
- 2027-06-30
- FDA Drug
- Yes
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