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

Trial details

Who runs it

Pfizer

Trial code

NCT04585815

Record updated

2026. január 9.

Original description

Phase 1b/Phase 2 Umbrella Study; open-label, multi-center, parallel group study.Read full original descriptionShow less

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)

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.

Inclusion: 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: Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent; Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.(Arms B1 \& B2); 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; Confirmed progressive disease on 1st or 2nd imaging tumor assessment after initiation of therapy for advanced/metastatic NSCLC; 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:; Symptomatic brain metastasis, with exceptions; Additional Exclusion Criteria for Sub-Study A Phase 1b\&2:.

ClinicalTrials.gov NCT04585815