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

NCT04585815 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: B80110112020-002829-28
• Study Type: interventional
• Target: 34
• Locations: 4 countries
• Sites: 55

Brief 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. 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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Phase 1b of Sub-Study A: Percentage of Participants With Dose-Limiting Toxicities (DLT)

  DLT=AEs in DLT observation period (OP) related to any study intervention:Grade (G)4 neutropenia;thrombocytopenia or anemia;febrile neutropenia;neutropenic infection;G3 thrombocytopenia with bleeding. Any G\>=3 toxicity (except transient G3 fatigue, local reactions/headache that resolved to G\<=1/baseline; G3 nausea, vomiting controlled within 72 hrs, G3 hypertension controlled by medical therapy (MT), G3 diarrhea that improved to G\<=2 within 72 hrs, G3 skin toxicity that resolved to G\<=1 in \<7 days after MT, G3 endocrinopathies controlled by MT and tumors flare); Non-hematologic G3 lab abnormality \[LA\](medical intervention or hospitalization), or any G4 LA;ALT/AST\>3\*ULN (normal at baseline) or \>3\*ULN and doubling baseline (\>ULN at baseline) and associated with total bilirubin(TB) \>2\*ULN;or ALT/AST\>5\*ULN; or TB\>3\*ULN. Missing 75% of planned doses during DLT OP due to treatment-related toxicities. AE not listed/DLT criteria outside DLT OP was DLT at discretion of sponsor and investigator.

  Day 1 up to Day 28 of Cycle 1

• Phase 2 of Sub-Study A: Durable Objective Response Rate (ORR)

  Durable ORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 based on investigator assessment, lasting for at least 10 months from the date of first CR or PR until the date of the first documentation of disease progression (PD), death, or start of new anticancer therapy. CR was defined as complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \<10 millimeter \[mm\]). PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. PD was defined as 20% increase in sum of diameters of target measurable lesions above smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm.

  From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy

• Phase 1b of Sub-Study B: Percentage of Participants With DLT

  DLT=AEs in DLT OP related to any study intervention: G4 neutropenia; thrombocytopenia or anemia; neutropenia; neutropenic infection; G3 thrombocytopenia with bleeding. Any G\>=3 toxicity (except transient G3 fatigue, local reactions/headache that resolved to G\<=1/baseline; G3 nausea, vomiting controlled within 72 hrs, G3 hypertension controlled by MT, G3 diarrhea that improved to G\<=2 within 72 hrs, G3 skin toxicity that resolved to G\<=1 in \<7 days after MT, G3 endocrinopathies controlled by MT and tumors flare); Non-hematologic G3 LA (medical intervention or hospitalization), or any G4 LA;ALT/AST\>3\*ULN (normal at baseline) or \>3\*ULN and doubling baseline (\>ULN at baseline) and associated with TB \>2\*ULN; or ALT/AST\>5\*ULN; or TB\>3\*ULN. Missing 75% of planned doses during DLT OP due to treatment-related toxicities. AE not listed/DLT criteria outside DLT OP was DLT at discretion of sponsor and investigator.

  Day 1 up to Day 21 of Cycle 1

• Phase 2 Sub-Study B: Objective Response Rate

  ORR was defined as percentage of participants with confirmed CR or PR according to RECIST v1.1 based on investigator assessment, from the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy. CR was defined as complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \<10 millimeter \[mm\]). PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. PD was defined as 20% increase in sum of diameters of target measurable lesions above smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm.

  From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy (maximum of 21 months)

Secondary Outcomes (58)

• Phase 1b of Sub-Study A: Number of Participants With Adverse Events (AEs) Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

  From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum exposure = 38.66 months; maximum follow-up approximately 39.66 months)

• Phase 2 of Sub-Study A: Number of Participants With Adverse Events Graded According to NCI-CTCAE Version 5.0

  From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment

• Phase 1b of Sub-Study A: Number of Participants With Shift From Baseline in Hematology Parameters Values Based on CTCAE V5.0

  From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum exposure = 38.66 months; maximum follow-up approximately 39.66 months)

• Phase 1b of Sub-Study A: Number of Participants With Shift From Baseline in Chemistry Parameters Values Based on CTCAE V5.0

  From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum exposure = 38.66 months; maximum follow-up approximately 39.66 months)

• Phase 2 of Sub-Study A: Number of Participants With Laboratory Abnormalities

  From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment

Study Arms (2)

Sub-Study A

EXPERIMENTAL

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.

Drug: Sasanlimab Prefilled syringe; Drug: Encorafenib; Drug: Binimetinib

Sub-Study B

EXPERIMENTAL

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.

Drug: Sasanlimab; Drug: Axitinib; Drug: SEA-TGT

Interventions

Sasanlimab Prefilled syringe DRUG

prefilled syringe

Sub-Study A

Encorafenib DRUG

capsules

Sub-Study A

Binimetinib DRUG

tablets

Sub-Study A

Sasanlimab DRUG

solution supplied in vials

Sub-Study B

Axitinib DRUG

tablets

Sub-Study B

SEA-TGT DRUG

solution in vials

Sub-Study B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (55)

City of Hope Investigational Drug Services (IDS)

Duarte, California, 91010, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

UCSD Medical Center - Encinitas

Encinitas, California, 92024, United States

Location

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

Fresno, California, 93720, United States

Location

The Oncology Institute of Hope and Innovation

Glendale, California, 91204, United States

Location

Koman Family Outpatient Pavilion

La Jolla, California, 92037, United States

Location

Sulpizio Cardiovascular Center at UC San Diego Health

La Jolla, California, 92037, United States

Location

UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)

La Jolla, California, 92037, United States

Location

UC San Diego Moores Cancer Center - Investigational Drug Services

La Jolla, California, 92037, United States

Location

UCSD Perlman Medical Offices

La Jolla, California, 92037, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

The Oncology Institute of Hope and Innovation

Long Beach, California, 90805, United States

Location

The Oncology Institute of Hope and Innovation

Los Angeles, California, 90015, United States

Location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

UC San Diego Medical Center - Hillcrest

San Diego, California, 92103, United States

Location

The Oncology Institute of Hope and Innovation

Santa Ana, California, 92705, United States

Location

UCSD Medical Center - Vista

Vista, California, 92081, United States

Location

The Oncology Institute of Hope and Innovation

Whittier, California, 90602, United States

Location

AdventHealth Celebration Infusion Center

Celebration, Florida, 34747, United States

Location

AdventHealth Medical Group Oncology Research at Celebration

Celebration, Florida, 34747, United States

Location

Advent Health Orlando - Investigational Drug Services

Orlando, Florida, 32804, United States

Location

AdventHealth Orlando Infusion Center

Orlando, Florida, 32804, United States

Location

AdventHealth Orlando

Orlando, Florida, 32804, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Henry Ford Medical Center - Fairlane

Dearborn, Michigan, 48126, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Henry Ford Medical Center - Columbus

Novi, Michigan, 48377, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Mount Sinai Hospital Pharmacy

New York, New York, 10029, United States

Location

Tennessee Oncology PLLC

Dickson, Tennessee, 37055, United States

Location

Tennessee Oncology PLLC

Franklin, Tennessee, 37067, United States

Location

Tennessee Oncology PLLC

Gallatin, Tennessee, 37066, United States

Location

Tennessee Oncology PLLC

Hendersonville, Tennessee, 37075, United States

Location

Tennessee Oncology PLLC

Hermitage, Tennessee, 37076, United States

Location

Tennessee Oncology PLLC

Lebanon, Tennessee, 37090, United States

Location

Tennessee Oncology PLLC

Murfreesboro, Tennessee, 37129, United States

Location

Sarah Cannon Research Institute - Pharmacy

Nashville, Tennessee, 37203, United States

Location

Tennessee Oncology PLLC

Nashville, Tennessee, 37203, United States

Location

Tennessee Oncology PLLC

Nashville, Tennessee, 37205, United States

Location

Tennessee Oncology PLLC

Nashville, Tennessee, 37207, United States

Location

Tennessee Oncology PLLC

Nashville, Tennessee, 37211, United States

Location

Tennessee Oncology PLLC

Shelbyville, Tennessee, 37160, United States

Location

Tennessee Oncology PLLC

Smyrna, Tennessee, 37167, United States

Location

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

Concord Hospital

Concord, New South Wales, 2139, Australia

Location

GenesisCare North Shore

St Leonards, New South Wales, 2065, Australia

Location

North Shore Radiology and Nuclear Medicine

St Leonards, New South Wales, 2065, Australia

Location

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Antwerp University Hospital

Edegem, Antwerpen, 2650, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Chung Shan Medical University Hospital

Taichung, 40201, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Koo Foundation Sun Yat -Sen Cancer Center

Taipei, 112, Taiwan

Location

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, 112, Taiwan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Neoplasm Metastasis

Interventions

encorafenib; binimetinib; Axitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated, and no data was collected and there are no results for this in the record.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 14, 2020
• Study Start: November 10, 2020
• Primary Completion: May 17, 2023
• Study Completion: October 29, 2024
• Last Updated: January 9, 2026
• Results First Posted: June 22, 2023

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

BE (2); AU (5); US (43); TW (5)