Trial Title:
Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study)
NCT ID:
NCT04585815
Condition:
Carcinoma, Non-Small-Cell Lung
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Axitinib
Conditions: 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
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sasanlimab Prefilled syringe
Description:
prefilled syringe
Arm group label:
Sub-Study A
Intervention type:
Drug
Intervention name:
Encorafenib
Description:
capsules
Arm group label:
Sub-Study A
Intervention type:
Drug
Intervention name:
Binimetinib
Description:
tablets
Arm group label:
Sub-Study A
Intervention type:
Drug
Intervention name:
Sasanlimab
Description:
solution supplied in vials
Arm group label:
Sub-Study B
Intervention type:
Drug
Intervention name:
Axitinib
Description:
tablets
Arm group label:
Sub-Study B
Intervention type:
Drug
Intervention name:
SEA-TGT
Description:
solution in vials
Arm group label:
Sub-Study B
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.
Detailed 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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope Investigational Drug Services (IDS)
Address:
City:
Duarte
Zip:
91010
Country:
United States
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Facility:
Name:
UCSD Medical Center - Encinitas
Address:
City:
Encinitas
Zip:
92024
Country:
United States
Facility:
Name:
California Cancer Associates for Research and Excellence, Inc (cCARE)
Address:
City:
Fresno
Zip:
93720
Country:
United States
Facility:
Name:
The Oncology Institute of Hope and Innovation
Address:
City:
Glendale
Zip:
91204
Country:
United States
Facility:
Name:
UC San Diego Moores Cancer Center - Investigational Drug Services
Address:
City:
La Jolla
Zip:
92037-0845
Country:
United States
Facility:
Name:
Koman Family Outpatient Pavilion
Address:
City:
La Jolla
Zip:
92037
Country:
United States
Facility:
Name:
Sulpizio Cardiovascular Center at UC San Diego Health
Address:
City:
La Jolla
Zip:
92037
Country:
United States
Facility:
Name:
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
Address:
City:
La Jolla
Zip:
92037
Country:
United States
Facility:
Name:
UCSD Perlman Medical Offices
Address:
City:
La Jolla
Zip:
92037
Country:
United States
Facility:
Name:
UC San Diego Moores Cancer Center
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Facility:
Name:
The Oncology Institute of Hope and Innovation
Address:
City:
Long Beach
Zip:
90805
Country:
United States
Facility:
Name:
The Oncology Institute of Hope and Innovation
Address:
City:
Los Angeles
Zip:
90015
Country:
United States
Facility:
Name:
USC/Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Facility:
Name:
UC San Diego Medical Center - Hillcrest
Address:
City:
San Diego
Zip:
92103
Country:
United States
Facility:
Name:
The Oncology Institute of Hope and Innovation
Address:
City:
Santa Ana
Zip:
92705
Country:
United States
Facility:
Name:
UCSD Medical Center - Vista
Address:
City:
Vista
Zip:
92081
Country:
United States
Facility:
Name:
The Oncology Institute of Hope and Innovation
Address:
City:
Whittier
Zip:
90602
Country:
United States
Facility:
Name:
UCHealth Memorial Hospital Central
Address:
City:
Colorado Springs
Zip:
80909
Country:
United States
Facility:
Name:
UCHealth Memorial Hospital North
Address:
City:
Colorado Springs
Zip:
80920
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Altamonte Springs
Zip:
32701
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Bonita Springs
Zip:
34135
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Bradenton
Zip:
34211
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Brandon
Zip:
33511
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Cape Coral
Zip:
33909
Country:
United States
Facility:
Name:
AdventHealth Celebration Infusion Center
Address:
City:
Celebration
Zip:
34747
Country:
United States
Facility:
Name:
AdventHealth Medical Group Oncology Research at Celebration
Address:
City:
Celebration
Zip:
34747
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Clearwater
Zip:
33761
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Fort Myers
Zip:
33901
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Fort Myers
Zip:
33905
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Fort Myers
Zip:
33908
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Gainesville
Zip:
32605
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Largo
Zip:
33770
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Lecanto
Zip:
34461
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Naples
Zip:
34102
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Ocala
Zip:
34474
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Orange City
Zip:
32763
Country:
United States
Facility:
Name:
Advent Health Orlando - Investigational Drug Services
Address:
City:
Orlando
Zip:
32804
Country:
United States
Facility:
Name:
AdventHealth Orlando Infusion Center
Address:
City:
Orlando
Zip:
32804
Country:
United States
Facility:
Name:
AdventHealth Orlando
Address:
City:
Orlando
Zip:
32804
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Orlando
Zip:
32806
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Port Charlotte
Zip:
33980
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Saint Petersburg
Zip:
33705
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Sarasota
Zip:
34232
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Sarasota
Zip:
34236
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Spring Hill
Zip:
34608
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Tampa
Zip:
33607
Country:
United States
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Tavares
Zip:
32778
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
The Villages
Zip:
32159
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Trinity
Zip:
34655
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Venice
Zip:
34285
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Venice
Zip:
34292
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Winter Park
Zip:
32792
Country:
United States
Facility:
Name:
University of Maryland Greenebaum Comprehensive Cancer Center
Address:
City:
Baltimore
Zip:
21201
Country:
United States
Facility:
Name:
University of Maryland Medical Center -IDS Pharmacy
Address:
City:
Baltimore
Zip:
21201
Country:
United States
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Facility:
Name:
Ophthalmic Consultants of Boston Inc (OCB)
Address:
City:
Boston
Zip:
02114
Country:
United States
Facility:
Name:
Henry Ford Medical Center - Fairlane
Address:
City:
Dearborn
Zip:
48126
Country:
United States
Facility:
Name:
Henry Ford Hospital
Address:
City:
Detroit
Zip:
48202
Country:
United States
Facility:
Name:
Henry Ford Medical Center - Columbus
Address:
City:
Novi
Zip:
48377
Country:
United States
Facility:
Name:
Atlantic Health System / Morristown Medical Center
Address:
City:
Morristown
Zip:
07962
Country:
United States
Facility:
Name:
Morristown Medical Center
Address:
City:
Morristown
Zip:
07962
Country:
United States
Facility:
Name:
Medical Diagnostic Associates
Address:
City:
Summit
Zip:
07901
Country:
United States
Facility:
Name:
Overlook Medical Center
Address:
City:
Summit
Zip:
07901
Country:
United States
Facility:
Name:
Icahn School of Medicine at Mount Sinai
Address:
City:
New York
Zip:
10029
Country:
United States
Facility:
Name:
Mount Sinai Hospital Pharmacy
Address:
City:
New York
Zip:
10029
Country:
United States
Facility:
Name:
Tennessee Oncology PLLC
Address:
City:
Dickson
Zip:
37055
Country:
United States
Facility:
Name:
Tennessee Oncology PLLC
Address:
City:
Franklin
Zip:
37067
Country:
United States
Facility:
Name:
Tennessee Oncology PLLC
Address:
City:
Gallatin
Zip:
37066
Country:
United States
Facility:
Name:
Tennessee Oncology PLLC
Address:
City:
Hendersonville
Zip:
37075
Country:
United States
Facility:
Name:
Tennessee Oncology PLLC
Address:
City:
Hermitage
Zip:
37076
Country:
United States
Facility:
Name:
Tennessee Oncology PLLC
Address:
City:
Lebanon
Zip:
37090
Country:
United States
Facility:
Name:
Tennessee Oncology PLLC
Address:
City:
Murfreesboro
Zip:
37129
Country:
United States
Facility:
Name:
Sarah Cannon Research Institute - Pharmacy
Address:
City:
Nashville
Zip:
37203
Country:
United States
Facility:
Name:
Tennessee Oncology PLLC
Address:
City:
Nashville
Zip:
37203
Country:
United States
Facility:
Name:
Tennessee Oncology PLLC
Address:
City:
Nashville
Zip:
37205
Country:
United States
Facility:
Name:
Tennessee Oncology PLLC
Address:
City:
Nashville
Zip:
37207
Country:
United States
Facility:
Name:
Tennessee Oncology PLLC
Address:
City:
Nashville
Zip:
37211
Country:
United States
Facility:
Name:
Tennessee Oncology PLLC
Address:
City:
Shelbyville
Zip:
37160
Country:
United States
Facility:
Name:
Tennessee Oncology PLLC
Address:
City:
Smyrna
Zip:
37167
Country:
United States
Facility:
Name:
Chris O'Brien Lifehouse
Address:
City:
Camperdown
Zip:
2050
Country:
Australia
Facility:
Name:
Concord Hospital
Address:
City:
Concord
Zip:
2139
Country:
Australia
Facility:
Name:
GenesisCare North Shore
Address:
City:
St Leonards
Zip:
2065
Country:
Australia
Facility:
Name:
North Shore Radiology and Nuclear Medicine
Address:
City:
St Leonards
Zip:
2065
Country:
Australia
Facility:
Name:
Austin Health
Address:
City:
Heidelberg
Zip:
3084
Country:
Australia
Facility:
Name:
Antwerp University Hospital
Address:
City:
Edegem
Zip:
2650
Country:
Belgium
Facility:
Name:
UZ Gent
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Facility:
Name:
UZ Leuven
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Facility:
Name:
Chung Shan Medical University Hospital
Address:
City:
Taichung
Zip:
40201
Country:
Taiwan
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei City
Zip:
100
Country:
Taiwan
Facility:
Name:
Koo Foundation Sun Yat -Sen Cancer Center
Address:
City:
Taipei City
Zip:
112
Country:
Taiwan
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
10002
Country:
Taiwan
Facility:
Name:
Koo Foundation Sun Yat-Sen Cancer Center
Address:
City:
Taipei
Zip:
112
Country:
Taiwan
Facility:
Name:
Sarah Cannon Research Institute UK
Address:
City:
London
Zip:
W1G 6AD
Country:
United Kingdom
Facility:
Name:
Royal Victoria Infirmary
Address:
City:
Newcastle upon Tyne
Zip:
NE1 4LP
Country:
United Kingdom
Facility:
Name:
Sir Bobby Robson Cancer Trials Research Centre
Address:
City:
Newcastle upon Tyne
Zip:
NE7 7DN
Country:
United Kingdom
Start date:
November 10, 2020
Completion date:
October 31, 2024
Lead sponsor:
Agency:
Pfizer
Agency class:
Industry
Source:
Pfizer
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT04585815
https://pmiform.com/clinical-trial-info-request?StudyID=B8011011
