Lung Cancer Clinical Trial

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

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 remains active, enrolment is ongoing.

View Full Description

Full 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.

View Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

375

Study ID:

NCT04585815

Recruitment Status:

Recruiting

Sponsor:

Pfizer

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There are 85 Locations for this study

See Locations Near You

City of Hope Investigational Drug Services (IDS)
Duarte California, 91010, United States
City of Hope
Duarte California, 91010, United States
UCSD Medical Center - Encinitas
Encinitas California, 92024, United States
California Cancer Associates for Research and Excellence, Inc (cCARE)
Fresno California, 93720, United States
The Oncology Institute of Hope and Innovation
Glendale California, 91204, United States
UC San Diego Moores Cancer Center - Investigational Drug Services
La Jolla California, 92037, United States
Koman Family Outpatient Pavilion
La Jolla California, 92037, United States
Sulpizio Cardiovascular Center at UC San Diego Health
La Jolla California, 92037, United States
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
La Jolla California, 92037, United States
UCSD Perlman Medical Offices
La Jolla California, 92037, United States
UC San Diego Moores Cancer Center
La Jolla California, 92093, United States
The Oncology Institute of Hope and Innovation
Long Beach California, 90805, United States
The Oncology Institute of Hope and Innovation
Los Angeles California, 90015, United States
Keck Hospital of USC
Los Angeles California, 90033, United States
Keck Medicine of USC - USC Roski Eye Institute
Los Angeles California, 90033, United States
LAC + USC Medical Center
Los Angeles California, 90033, United States
USC/Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Keck Hospital of USC Pasadena
Pasadena California, 91105, United States
Keck Medical Center of USC Pasadena
Pasadena California, 91105, United States
UC San Diego Medical Center - Hillcrest
San Diego California, 92103, United States
The Oncology Institute of Hope and Innovation
Santa Ana California, 92705, United States
UCSD Medical Center - Vista
Vista California, 92081, United States
The Oncology Institute of Hope and Innovation
Whittier California, 90602, United States
UCHealth Memorial Hospital Central
Colorado Springs Colorado, 80909, United States
UCHealth Memorial Hospital North
Colorado Springs Colorado, 80920, United States
Florida Cancer Specialists
Altamonte Springs Florida, 32701, United States
Florida Cancer Specialists
Bonita Springs Florida, 34135, United States
Florida Cancer Specialists
Bradenton Florida, 34211, United States
Florida Cancer Specialists
Brandon Florida, 33511, United States
Florida Cancer Specialists
Cape Coral Florida, 33909, United States
AdventHealth Celebration Infusion Center
Celebration Florida, 34747, United States
AdventHealth Medical Group Oncology Research at Celebration
Celebration Florida, 34747, United States
Florida Cancer Specialists
Clearwater Florida, 33761, United States
Florida Cancer Specialists
Fort Myers Florida, 33901, United States
Florida Cancer Specialists
Fort Myers Florida, 33905, United States
Florida Cancer Specialists
Fort Myers Florida, 33908, United States
Florida Cancer Specialists
Gainesville Florida, 32605, United States
Florida Cancer Specialists
Largo Florida, 33770, United States
Florida Cancer Specialists
Lecanto Florida, 34461, United States
Florida Cancer Specialists
Naples Florida, 34102, United States
Florida Cancer Specialists
Ocala Florida, 34474, United States
Florida Cancer Specialists
Orange City Florida, 32763, United States
Advent Health Orlando - Investigational Drug Services
Orlando Florida, 32804, United States
AdventHealth Hematology and Oncology
Orlando Florida, 32804, United States
AdventHealth Orlando Infusion Center
Orlando Florida, 32804, United States
Florida Cancer Specialists
Orlando Florida, 32806, United States
Florida Cancer Specialists
Port Charlotte Florida, 33980, United States
Florida Cancer Specialists
Saint Petersburg Florida, 33705, United States
Florida Cancer Specialists
Sarasota Florida, 34232, United States
Florida Cancer Specialists
Sarasota Florida, 34236, United States
Florida Cancer Specialists
Spring Hill Florida, 34608, United States
Florida Cancer Specialists
Tampa Florida, 33607, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Florida Cancer Specialists
Tavares Florida, 32778, United States
Florida Cancer Specialists
The Villages Florida, 32159, United States
Florida Cancer Specialists
Trinity Florida, 34655, United States
Florida Cancer Specialists
Venice Florida, 34285, United States
Florida Cancer Specialists
Venice Florida, 34292, United States
Florida Cancer Specialists
Winter Park Florida, 32792, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore Maryland, 21201, United States
University of Maryland Medical Center -IDS Pharmacy
Baltimore Maryland, 21201, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Ophthalmic Consultants of Boston Inc (OCB)
Boston Massachusetts, 02114, United States
Brigham and Women's Hospital (BWH)
Boston Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Dana-Farber Cancer Institute - Chestnut Hill
Newton Massachusetts, 02459, United States
Henry Ford Medical Center - Fairlane
Dearborn Michigan, 48126, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Henry Ford Medical Center - Columbus
Novi Michigan, 48377, United States
Atlantic Health System / Morristown Medical Center
Morristown New Jersey, 07962, United States
Morristown Medical Center
Morristown New Jersey, 07962, United States
Medical Diagnostic Associates
Summit New Jersey, 07901, United States
Overlook Medical Center
Summit New Jersey, 07901, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Mount Sinai Hospital Pharmacy
New York New York, 10029, United States
Tennessee Oncology PLLC
Dickson Tennessee, 37055, United States
Tennessee Oncology PLLC
Franklin Tennessee, 37067, United States
Tennessee Oncology PLLC
Gallatin Tennessee, 37066, United States
Tennessee Oncology PLLC
Hendersonville Tennessee, 37075, United States
Tennessee Oncology PLLC
Hermitage Tennessee, 37076, United States
Tennessee Oncology PLLC
Lebanon Tennessee, 37090, United States
Tennessee Oncology PLLC
Murfreesboro Tennessee, 37129, United States
Sarah Cannon Research Institute - Pharmacy
Nashville Tennessee, 37203, United States
Tennessee Oncology PLLC
Nashville Tennessee, 37203, United States
Tennessee Oncology PLLC
Nashville Tennessee, 37205, United States
Tennessee Oncology PLLC
Nashville Tennessee, 37207, United States
Tennessee Oncology PLLC
Nashville Tennessee, 37211, United States
Tennessee Oncology PLLC
Shelbyville Tennessee, 37160, United States
Tennessee Oncology PLLC
Smyrna Tennessee, 37167, United States
Chris O'Brien Lifehouse
Camperdown New South Wales, 2050, Australia
Concord Hospital
Concord New South Wales, 2139, Australia
GenesisCare North Shore
St Leonards New South Wales, 2065, Australia
North Shore Radiology and Nuclear Medicine
St Leonards New South Wales, 2065, Australia
Austin Health
Heidelberg Victoria, 3084, Australia
Antwerp University Hospital
Edegem Antwerpen, 2650, Belgium
UZ Gent
Gent , 9000, Belgium
UZ Leuven
Leuven , 3000, Belgium
Princess Margaret Cancer Centre - University Health Network
Toronto Ontario, M5G 2, Canada
Chung Shan Medical University Hospital
Taichung , 40201, Taiwan
National Taiwan University Hospital
Taipei City , 100, Taiwan
Koo Foundation Sun Yat -Sen Cancer Center
Taipei City , 112, Taiwan
National Taiwan University Hospital
Taipei , 10002, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei , 112, Taiwan
Sarah Cannon Research Institute UK
London , W1G 6, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne , NE1 4, United Kingdom
Sir Bobby Robson Cancer Trials Research Centre
Newcastle upon Tyne , NE7 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

375

Study ID:

NCT04585815

Recruitment Status:

Recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

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