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NCT04585815

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

Last Updated: 2024-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-10

Study Completion Date

2024-10-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Carcinoma, Non-Small-Cell Lung

Keywords

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Sasanlimab Prefilled syringe

Intervention Type DRUG

prefilled syringe

Encorafenib

Intervention Type DRUG

capsules

Binimetinib

Intervention Type DRUG

tablets

Sub-Study B

Sasanlimab will be administered subcutaneously. Axitinib will be administered orally. SEA-TGT will be administered intravenously. Treatments will be administered until progressive disease, unacceptable AE, patient withdraws, or study is terminated.

Group Type EXPERIMENTAL

Sasanlimab

Intervention Type DRUG

solution supplied in vials

Axitinib

Intervention Type DRUG

tablets

SEA-TGT

Intervention Type DRUG

solution in vials

Interventions

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Sasanlimab Prefilled syringe

prefilled syringe

Intervention Type DRUG

Encorafenib

capsules

Intervention Type DRUG

Binimetinib

tablets

Intervention Type DRUG

Sasanlimab

solution supplied in vials

Intervention Type DRUG

Axitinib

tablets

Intervention Type DRUG

SEA-TGT

solution in vials

Intervention Type DRUG

Eligibility Criteria

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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.

-BRAFV600E mutation in tumor tissue or plasma as determined by a local laboratory PCR or NGS assay and documented in a local pathology report.

-Any line of therapy for locally advanced/metastatic NSCLC.

-Previously untreated for locally advanced/metastatic NSCLC

-Any line of therapy for locally advanced/metastatic NSCLC.

* 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 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.

* EGFR mutation, ALK fusion oncogene, or ROS1 rearrangement.
* Prior treatment with any BRAF inhibitor or MEK inhibitor.

-Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.

-Documentation of any tumor-driving molecular alteration (eg, BRAF, EGFR, ALK)

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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City of Hope Investigational Drug Services (IDS)

Duarte, California, United States

Site Status

City of Hope

Duarte, California, United States

Site Status

UCSD Medical Center - Encinitas

Encinitas, California, United States

Site Status

California Cancer Associates for Research and Excellence, Inc (cCARE)

Fresno, California, United States

Site Status