Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Encinitas, California and other locations
Dates
study started
estimated completion

Description

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.

Official 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)

Keywords

Carcinoma, Non-Small-Cell Lung 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 Lung Neoplasms Sasanlimab Prefillled syringe Sub-Study A Sub-Study B

Eligibility

You can join if…

Open to people ages 18 years and up

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%

You CAN'T join if...

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.

Locations

  • UCSD Medical Center - Encinitas accepting new patients
    Encinitas California 92024 United States
  • UC San Diego Moores Cancer Center - Investigational Drug Services accepting new patients
    La Jolla California 92037-0845 United States
  • Sulpizio Cardiovascular Center at UC San Diego Health accepting new patients
    La Jolla California 92037 United States
  • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) accepting new patients
    La Jolla California 92037 United States
  • UCSD Perlman Medical Offices accepting new patients
    La Jolla California 92037 United States
  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • UC San Diego Medical Center - Hillcrest accepting new patients
    San Diego California 92103 United States
  • UCSD Medical Center - Vista accepting new patients
    Vista California 92081 United States
  • Koman Family Outpatient Pavilion accepting new patients
    La Jolla California 92037 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
ID
NCT04585815
Phase
Phase 1/2
Study Type
Interventional
Last Updated