Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study)
Carcinoma, Non-Small-Cell Lung
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Non-Small-Cell Lung Carcinoma, NSCLC, non small cell lung cancer, non-small cell lung cancer, BRAF mutation, BRAF V600e, BRAF, B-RAF NSCLC, lung cancer, immunotherapy, sasanlimab, encorafenib, binimetinib, axitinib, SEA-TGT, TIGIT, locally advanced, metastatic, ECOG 0, ECOG 1, Stage 3B, Stage IV, previously untreated, second-line therapy, first-line therapy
Eligibility Criteria
Inclusion Criteria Umbrella Phase 1b & 2:
- Histologically or cytologically confirmed locally advanced/metastatic (Stage IIIB-IV) NSCLC.
- At least one measurable lesion per RECIST v1.1 at Screening.
- ECOG Performance Status 0 or 1.
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
- Adequate hepatic, renal, and bone marrow function.
Additional Inclusion Criteria for Sub-Study A Phase 1b &2:
-BRAFV600E mutation in tumor tissue or plasma as determined by a local laboratory PCR or NGS assay and documented in a local pathology report.
Additional Inclusion Criteria for Sub-Study A Phase 1b only:
-Any line of therapy for locally advanced/metastatic NSCLC.
Additional Inclusion Criteria for Sub-Study A Phase 2 only:
-Previously untreated for locally advanced/metastatic NSCLC
Additional Inclusion Criteria for Sub-Study B Phase 1b only::
-Any line of therapy for locally advanced/metastatic NSCLC.
Additional Inclusion Criteria for Sub-Study B Phase 2 only:
- Previously untreated for locally advanced/metastatic NSCLC (Arms B1 & B2), or
- One or 2 prior lines of therapy for advanced/metastatic NSCLC (Arm B3), including immune checkpoint inhibitor treatment + chemotherapy, and have progressed during or after that therapy.
- PD-L1 TPS ≥1%
Exclusion Criteria Umbrella Phase 1b &2:
- Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
- Active non-infectious pneumonitis, pulmonary fibrosis, or known history of immune-mediated pneumonitis.
- Active infection requiring systemic therapy.
- Clinically significant cardiovascular disease.
- Other malignancy within 2 years of first dose, with exceptions.
- Symptomatic brain metastasis, with exceptions.
Additional Exclusion Criteria for Sub-Study A Phase 1b&2:
- EGFR mutation, ALK fusion oncogene, or ROS1 rearrangement.
- Prior treatment with any BRAF inhibitor or MEK inhibitor.
Additional Exclusion Criteria for Sub-Study A Phase 2 only:
-Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.
Additional Exclusion Criteria for Sub-Study B Phase 1b&2:
-Documentation of any tumor-driving molecular alteration (eg, BRAF, EGFR, ALK)
Additional Exclusion Criteria for Sub-Study B Phase 2 only:
- Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.(Arms B1 & B2)
- Confirmed progressive disease on 1st or 2nd imaging tumor assessment after initiation of therapy for advanced/metastatic NSCLC.
Sites / Locations
- City of Hope Investigational Drug Services (IDS)
- City of Hope
- UCSD Medical Center - Encinitas
- California Cancer Associates for Research and Excellence, Inc (cCARE)
- The Oncology Institute of Hope and Innovation
- UC San Diego Moores Cancer Center - Investigational Drug Services
- Koman Family Outpatient Pavilion
- Sulpizio Cardiovascular Center at UC San Diego Health
- UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
- UCSD Perlman Medical Offices
- UC San Diego Moores Cancer Center
- The Oncology Institute of Hope and Innovation
- The Oncology Institute of Hope and Innovation
- USC/Norris Comprehensive Cancer Center
- UC San Diego Medical Center - Hillcrest
- The Oncology Institute of Hope and Innovation
- UCSD Medical Center - Vista
- The Oncology Institute of Hope and Innovation
- UCHealth Memorial Hospital Central
- UCHealth Memorial Hospital North
- Florida Cancer Specialists
- Florida Cancer Specialists
- Florida Cancer Specialists
- Florida Cancer Specialists
- Florida Cancer Specialists
- AdventHealth Celebration Infusion Center
- AdventHealth Medical Group Oncology Research at Celebration
- Florida Cancer Specialists
- Florida Cancer Specialists
- Florida Cancer Specialists
- Florida Cancer Specialists
- Florida Cancer Specialists
- Florida Cancer Specialists
- Florida Cancer Specialists
- Florida Cancer Specialists
- Florida Cancer Specialists
- Florida Cancer Specialists
- Advent Health Orlando - Investigational Drug Services
- AdventHealth Hematology and Oncology
- AdventHealth Orlando Infusion Center
- Florida Cancer Specialists
- Florida Cancer Specialists
- Florida Cancer Specialists
- Florida Cancer Specialists
- Florida Cancer Specialists
- Florida Cancer Specialists
- Florida Cancer Specialists
- Moffitt Cancer Center
- Florida Cancer Specialists
- Florida Cancer Specialists
- Florida Cancer Specialists
- Florida Cancer Specialists
- Florida Cancer Specialists
- Florida Cancer Specialists
- University of Maryland Greenebaum Comprehensive Cancer Center
- University of Maryland Medical Center -IDS Pharmacy
- Massachusetts General Hospital
- Ophthalmic Consultants of Boston Inc (OCB)
- Henry Ford Medical Center - Fairlane
- Henry Ford Hospital
- Henry Ford Medical Center - Columbus
- Atlantic Health System / Morristown Medical Center
- Morristown Medical Center
- Medical Diagnostic Associates
- Overlook Medical Center
- Icahn School of Medicine at Mount Sinai
- Mount Sinai Hospital Pharmacy
- Tennessee Oncology PLLC
- Tennessee Oncology PLLC
- Tennessee Oncology PLLC
- Tennessee Oncology PLLC
- Tennessee Oncology PLLC
- Tennessee Oncology PLLC
- Tennessee Oncology PLLC
- Sarah Cannon Research Institute - Pharmacy
- Tennessee Oncology PLLC
- Tennessee Oncology PLLC
- Tennessee Oncology PLLC
- Tennessee Oncology PLLC
- Tennessee Oncology PLLC
- Tennessee Oncology PLLC
- Chris O'Brien Lifehouse
- Concord Hospital
- GenesisCare North Shore
- North Shore Radiology and Nuclear Medicine
- Austin Health
- Antwerp University Hospital
- UZ Gent
- UZ Leuven
- Chung Shan Medical University Hospital
- National Taiwan University Hospital
- Koo Foundation Sun Yat -Sen Cancer Center
- National Taiwan University Hospital
- Koo Foundation Sun Yat-Sen Cancer Center
- Sarah Cannon Research Institute UK
- Royal Victoria Infirmary
- Sir Bobby Robson Cancer Trials Research Centre
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Sub-Study A
Sub-Study B
Sasanlimab will be administered subcutaneously. Encorafenib & binimetinib will be administered orally. Treatments will be administered until progressive disease, unacceptable AE, participant withdraws, or study is terminated.
Sasanlimab will be administered subcutaneously. Axitinib will be administered orally. SEA-TGT will be administered intravenously. Treatments will be administered until progressive disease, unacceptable AE, patient withdraws, or study is terminated.