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

Titre officiel

A Phase 1b/2 Open Label Umbrella Study of Sasanlimab Combined With Anti-Cancer Therapies Targeting Multiple Molecular Mechanisms in Participants With Non-Small Cell Lung Cancer (NSCLC)

Sommaire:

Phase 1b/Phase 2 Umbrella Study; open-label, multi-centre, 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-tumour activity of the combination.

Description de l'essai

Primary Outcome:

• Percentage of participants with Dose-limiting toxicities (DLT)
• Durable Objective Response Rate - Percentage of Participants With Objective Response
• Objective Response Rate-Percentage of Participants with Objective Response

Secondary Outcome:

• Number of participants with Treatment-Emergent Adverse Events
• Percentage of participants with Treatment-Emergent Adverse Events
• Number of Participants with Treatment-Emergent Laboratory Abnormalities
• Percentage of Participants with Treatment-Emergent Laboratory Abnormalities
• Durable Objective Response Rate - Percentage of Participants With Objective Response
• Objective Response Rate-Percentage of Participants with Objective Response
• Duration of Response (DR)
• Time to Tumour Response (TTR)
• Progression-Free Survival (PFS)
• Overall Survival
• Incidence of Anti-Drug Antibody (ADA) for the study drugs
• Neutalizing antibody (NAb) titers for sasanlimab
• Association between Objective Response and PD-L1 expression at baseline
• PK Parameter Ctrough
• European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Score
• European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) Score
• Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Score
• Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) Score

Landscape 1011 is a clinical research study for people with advanced (stage 3b or 4) non-small cell lung cancer (NSCLC). The purpose of this study is to learn if the study medicine (sasanlimab, a type of immunotherapy) along with other study medicines is safe and effective in people with non-small cell lung cancer that has spread outside of the lungs. There are currently two sub-studies using different types of medicines. People in the first sub-study will receive sasanlimab as a subcutaneous (under the skin) injection at the study clinic every 4 weeks. Additionally, they will take targeted cancer therapies encorafenib by mouth once a day and binimetinib by mouth twice a day at home. People in the second sub-study will receive the study medicine sasanlimab as a subcutaneous (under the skin) injection at the study clinic every 3 weeks and will also receive SEA-TGT (an immunotherapy) by infusion every three weeks. Additionally, they will take axitinib (a targeted therapy) by mouth twice a day at home. In addition to taking the study drugs, participants in the sub-studies will be asked to visit the clinic for health checks. These include health questions, physical examinations, blood and urine samples, and imaging scans. These assessments help the study doctor and team to monitor the participants' safety and well-being, and to see how their cancer is responding to the treatment. Participants will continue in the study until the cancer is no longer responding to the study medicine.

Voir cet essai sur ClinicalTrials.gov