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Clinical Trial 20939

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT04585815

Phase: Phase I/II
Prinicipal Investigator: Michael Shafique

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Overview

Study Title

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)

Summary

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.

Objective

Phase 1b Primary Objective: To assess the DLT rate and estimate the MTD of sasanlimab in combination with encorafenib and binimetinib to recommend a RP2D for the combination. Phase 2 Primary Objective: To assess the durable ORR of sasanlimab in combination with encorafenib and binimetinib.

Treatments

Therapies

Medications

Binimetinib (); Encorafenib (); PF-06801591 (Sasanlimab); Sasanlimab ()

Inclusion 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

  • Exclusion Criteria

  • 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.

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