Umbrella Study of Sasanlimab Combined With Targeted Therapies in Participants With Non Small Cell Lung Cancer

• Status: Recruiting
• Trial end date: 2025-12-20
• Target enrollment: 0
• Participant gender: All

Summary

Phase 1b/Phase 2 open-label, multi-center, parallel group umbrella study.

Sasanlimab (a PD-1 antagonist monoclonal antibody) will be combined with a different targeted therapy in each sub-study. The Phase1b part of each sub-study will evaluate the safety of the combination and select the dose for the Phase 2 part. The Phase 2 part of each sub-study will evaluate the anti-tumor activity of the combination.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Axitinib

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.