drugset / Trial / NCT04585815

Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study)

NCT04585815

Phase 1/2 Terminated 34 enrolled Pfizer
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Phase 1b/Phase 2 Umbrella Study; open-label, multi-center, parallel group study. Sasanlimab (a PD-1 antagonist monoclonal antibody) will be combined with a different targeted therapy in each sub-study. Phase1b of each sub-study will evaluate the safety of the combination and select the dose for the Phase 2 portion. Phase 2 of each sub-study will evaluate the anti-tumor activity of the combination. Sub-Study A is active, not recruiting, ongoing participants are still receiving treatment in Phase 1, Phase 2 will not be initiated. Sub-study B is complete. All participants have discontinued treatment and any additional follow up required by protocol.

Timeline

Start
2020-11-10
Primary completion
2023-05-17
Completion
2024-10-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Axitinib Small molecule Oral
Subject Binimetinib Small molecule Oral
Subject Encorafenib Small molecule Oral
Subject SEA-TGT Unknown Intravenous
Subject Sasanlimab Monoclonal antibody Subcutaneous