Umbrella Study of Sasanlimab Combined With Targeted Therapies in Participants With Non Small Cell Lung Cancer
NCT04585815
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1-800-718-1021
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
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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Descriptive Information | |||||||
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Brief Title ICMJE | Umbrella Study of Sasanlimab Combined With Targeted Therapies in Participants With Non Small Cell Lung Cancer | ||||||
Official Title ICMJE | 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) | ||||||
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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 Phase 2 | ||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | Carcinoma, Non-Small-Cell Lung | ||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Sub-Study A
Sasanlimab will be administered subcutaneously. Encorafenib & binimetinib will be administered orally. Treatments will be administered until progressive disease, unacceptable AE, participant withdraws, or study is terminated. Interventions:
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE | 375 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | October 17, 2024 | ||||||
Estimated Primary Completion Date | October 17, 2024 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria Umbrella Phase 1b & 2:
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 Umbrella Phase 1b &2:
Additional Exclusion Criteria for Sub-Study A Phase 1b &2:
Additional Exclusion Criteria for Sub-Study A Phase 2 only: -Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents. | ||||||
Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Australia, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04585815 | ||||||
Other Study ID Numbers ICMJE | B8011011 2020-002829-28 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | December 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |