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

  • STATUS
    Recruiting
  • End date
    Dec 20, 2025
  • participants needed
    375
  • sponsor
    Pfizer
Updated on 1 December 2021
measurable disease
cancer chemotherapy
lung carcinoma

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.

Details
Condition Non-Small Cell Lung Cancer
Treatment Axitinib, Binimetinib, Encorafenib, Sasanlimab Prefillled syringe, SEA-TGT, Sasanlimab
Clinical Study IdentifierNCT04585815
SponsorPfizer
Last Modified on1 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent
Active infection requiring systemic therapy
Clinically significant cardiovascular disease
Other malignancy within 2 years of first dose, with exceptions
Symptomatic brain metastasis, with exceptions
Active non-infectious pneumonitis, pulmonary fibrosis, or known history of immune-mediated pneumonitis
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 A Phase 1b&2
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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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