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Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study)

NCT04585815

TerminatedPhase 1, Phase 2

Sponsor: Pfizer

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Sasanlimab Prefilled syringe, Encorafenib, Binimetinib, Sasanlimab, Axitinib

Countries: United States, Australia, Belgium, Taiwan

Phase 1b/Phase 2 Umbrella Study; open-label, multi-center, parallel group study. Sasanlimab (a PD-1 antagonist monoclonal antibody) will be combined with a different targeted therapy in each sub-study. Phase1b of each sub-study will evaluate the safety of the combination and select the dose for the Phase 2 portion. Phase 2 of each sub-study will evaluate the anti-tumor activity of the combination. Sub-Study A is active, not recruiting, ongoing participants are still receiving treatment in Phase 1, Phase 2 will not be initiated. Sub-study B is complete. All participants have discontinued treatment and any additional follow up required by protocol.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (55)

Duarte, California, United States
Duarte, California, United States
Encinitas, California, United States
Fresno, California, United States
Glendale, California, United States
La Jolla, California, United States
La Jolla, California, United States
La Jolla, California, United States
La Jolla, California, United States
La Jolla, California, United States
La Jolla, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
San Diego, California, United States
Santa Ana, California, United States
Vista, California, United States
Whittier, California, United States
Celebration, Florida, United States
Celebration, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Dearborn, Michigan, United States
Detroit, Michigan, United States
Novi, Michigan, United States
New York, New York, United States
New York, New York, United States
Dickson, Tennessee, United States
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