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

  • STATUS
    Recruiting
  • End date
    Dec 20, 2025
  • participants needed
    375
  • sponsor
    Pfizer
Updated on 23 May 2022
measurable disease
cancer chemotherapy
lung carcinoma

Summary

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.

Description

Landscape 1011 is a clinical research study for people with advanced (stage 3b or 4) non-small cell lung cancer (NSCLC). The purpose of this study is to learn if the study medicine (sasanlimab, a type of immunotherapy) along with other study medicines is safe and effective in people with non-small cell lung cancer that has spread outside of the lungs. There are currently two sub-studies using different types of medicines. People in the first sub-study will receive sasanlimab as a subcutaneous (under the skin) injection at the study clinic every 4 weeks. Additionally, they will take targeted cancer therapies encorafenib by mouth once a day and binimetinib by mouth twice a day at home.

People in the second sub-study will receive the study medicine sasanlimab as a subcutaneous (under the skin) injection at the study clinic every 3 weeks and will also receive SEA-TGT (an immunotherapy) by infusion every three weeks.

Additionally, they will take axitinib (a targeted therapy) by mouth twice a day at home.

In addition to taking the study drugs, participants in the sub-studies will be asked to visit the clinic for health checks. These include health questions, physical examinations, blood and urine samples, and imaging scans. These assessments help the study doctor and team to monitor the participants' safety and well-being, and to see how their cancer is responding to the treatment. Participants will continue in the study until the cancer is no longer responding to the study medicine.

Details
Condition Carcinoma, Non-Small-Cell Lung
Treatment Axitinib, Binimetinib, Encorafenib, Sasanlimab Prefillled syringe, SEA-TGT, Sasanlimab
Clinical Study IdentifierNCT04585815
SponsorPfizer
Last Modified on23 May 2022

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
Additional Inclusion Criteria for Sub-Study A Phase 1b only
NGS assay and documented in a local pathology report
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 infection requiring systemic therapy
Clinically significant cardiovascular disease
Other malignancy within 2 years of first dose, with exceptions
Symptomatic brain metastasis, with exceptions
EGFR mutation, ALK fusion oncogene, or ROS1 rearrangement
Prior treatment with any BRAF inhibitor or MEK inhibitor
Active or prior autoimmune disease that might deteriorate when receiving an
Additional Exclusion Criteria for Sub-Study A Phase 2 only
immunostimulatory agent
Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents
Active non-infectious pneumonitis, pulmonary fibrosis, or known history of
immune-mediated pneumonitis
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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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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