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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)

Description

Brief 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

N/A

Inclusion and Exclusion 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

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