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

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Sasanlimab Prefilled syringe
Encorafenib
Binimetinib
Sasanlimab
Axitinib
SEA-TGT
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • City of Hope Investigational Drug Services (IDS)
  • City of Hope
  • UCSD Medical Center - Encinitas
  • California Cancer Associates for Research and Excellence, Inc (cCARE)
  • The Oncology Institute of Hope and Innovation
  • UC San Diego Moores Cancer Center - Investigational Drug Services
  • Koman Family Outpatient Pavilion
  • Sulpizio Cardiovascular Center at UC San Diego Health
  • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
  • UCSD Perlman Medical Offices
  • UC San Diego Moores Cancer Center
  • The Oncology Institute of Hope and Innovation
  • The Oncology Institute of Hope and Innovation
  • USC/Norris Comprehensive Cancer Center
  • UC San Diego Medical Center - Hillcrest
  • The Oncology Institute of Hope and Innovation
  • UCSD Medical Center - Vista
  • The Oncology Institute of Hope and Innovation
  • UCHealth Memorial Hospital Central
  • UCHealth Memorial Hospital North
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • AdventHealth Celebration Infusion Center
  • AdventHealth Medical Group Oncology Research at Celebration
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Advent Health Orlando - Investigational Drug Services
  • AdventHealth Hematology and Oncology
  • AdventHealth Orlando Infusion Center
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Moffitt Cancer Center
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • University of Maryland Greenebaum Comprehensive Cancer Center
  • University of Maryland Medical Center -IDS Pharmacy
  • Massachusetts General Hospital
  • Ophthalmic Consultants of Boston Inc (OCB)
  • Henry Ford Medical Center - Fairlane
  • Henry Ford Hospital
  • Henry Ford Medical Center - Columbus
  • Atlantic Health System / Morristown Medical Center
  • Morristown Medical Center
  • Medical Diagnostic Associates
  • Overlook Medical Center
  • Icahn School of Medicine at Mount Sinai
  • Mount Sinai Hospital Pharmacy
  • Tennessee Oncology PLLC
  • Tennessee Oncology PLLC
  • Tennessee Oncology PLLC
  • Tennessee Oncology PLLC
  • Tennessee Oncology PLLC
  • Tennessee Oncology PLLC
  • Tennessee Oncology PLLC
  • Sarah Cannon Research Institute - Pharmacy
  • Tennessee Oncology PLLC
  • Tennessee Oncology PLLC
  • Tennessee Oncology PLLC
  • Tennessee Oncology PLLC
  • Tennessee Oncology PLLC
  • Tennessee Oncology PLLC
  • Chris O'Brien Lifehouse
  • Concord Hospital
  • GenesisCare North Shore
  • North Shore Radiology and Nuclear Medicine
  • Austin Health
  • Antwerp University Hospital
  • UZ Gent
  • UZ Leuven
  • Chung Shan Medical University Hospital
  • National Taiwan University Hospital
  • Koo Foundation Sun Yat -Sen Cancer Center
  • National Taiwan University Hospital
  • Koo Foundation Sun Yat-Sen Cancer Center
  • Sarah Cannon Research Institute UK
  • Royal Victoria Infirmary
  • Sir Bobby Robson Cancer Trials Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sub-Study A

Sub-Study B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs will be graded by the investigator according to NCI CTCAE version 5.0; where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening and Grade 5=death.
Phase 2 of Sub-Study A: Number of Participants With Adverse Events Graded According to NCI-CTCAE Version 5.0
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs were planned to be graded by the investigator according to NCI CTCAE version 5.0; where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening and Grade 5=death.
Phase 1b of Sub-Study A: Number of Participants With Laboratory Abnormalities
Following assessments will be performed: hematology: hemoglobin, platelet count, white blood cell (WBC) count, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils. Chemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate or carbon dioxide (CO2), C-reactive protein (CRP), alkaline phosphatase, sodium, potassium, magnesium chloride, total calcium, total bilirubin, total protein, blood urea nitrogen (BUN) or urea, creatinine, creatinine clearance, uric acid, glucose (random), lactate dehydrogenase, albumin, phosphorus or phosphate, amylase, lipase.
Phase 2 of Sub-Study A: Number of Participants With Laboratory Abnormalities
Hematology and clinical chemistry parameters were planned to be assessed.
Phase 1b of Sub-Study A: Durable Objective Response Rate
Durable ORR was defined as percentage of participants with confirmed CR or PR according to RECIST v1.1 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 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 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 is observed during therapy) with a minimum absolute increase of 5 mm.
Phase 1b of Sub-Study A: Objective Response Rate
Objective response rate is defined as percentage of participants with confirmed best overall response of CR or PR according to RECIST v1.1 from the date of first dose of study treatment until the date of the first documentation of PD. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.
Phase 2 of Sub-Study A: Objective Response Rate
Objective response rate is defined as percentage of participants with confirmed best overall response of CR or PR according to RECIST v1.1 from the date of first dose of study treatment until the date of the first documentation of PD. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.
Phase 2 of Sub-Study A: Duration of Response (DR)
DR was defined for participants with confirmed objective response (OR) as time from date of first documentation of OR to the date of first documentation of PD or death (any cause), whichever occurred first. OR=CR or PR according to RECIST v1.1 based on investigator assessment. CR and PR must be confirmed by repeat assessments performed no <4 weeks after criteria for response were first met. CR=complete disappearance of all target lesions (TLs) with exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR=greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions (TMLs). PD=20% increase in sum of diameters of TMLs above smallest sum observed (over baseline if no decrease in sum was observed during therapy), with a minimum absolute increase of 5 mm.
Phase 2 of Sub-Study A: Time to Tumor Response (TTR)
TTR is defined for participants with confirmed objective response as the time from the date of first dose of study treatment to the date of first documentation of objective response (CR or PR) which was subsequently confirmed. CR=complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR=greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.
Phase 2 of Sub-Study A: Progression-Free Survival (PFS)
PFS is defined as the time from the date of first dose of study treatment to the date of first documentation of PD or death due to any cause, whichever occurred first. PD=20% increase in sum of diameters of target measurable lesions above smallest sum observed (over baseline if no decrease in sum was observed during therapy), with a minimum absolute increase of 5 mm.
Phase 2 of Sub-Study A: Overall Survival (OS)
OS is defined as the time from the date of first dose of study treatment to the date of death due to any cause. Participants last known to be alive were planned to be censored at the date of last contact.
Phase 1b of Sub-Study A: Area Under the Concentration Verses Time Curve Over the Dosing Interval (AUCtau) After Single Dose of Sasanlimab
AUCtau was defined as area under the plasma concentration time curve from time zero to the next dose.
Phase 2 of Sub-Study A: Area Under the Concentration Verses Time Curve Over the Dosing Interval (AUCtau) After Single Dose of Sasanlimab
Phase 1b of Sub-Study A: Maximum Observed Plasma Concentration (Cmax) of Sasanlimab
Phase 2 of Sub-Study A: Maximum Observed Plasma Concentration (Cmax) of Sasanlimab
Phase 1b of Sub-Study A: Time for Cmax (Tmax) of Sasanlimab
Phase 2 of Sub-Study A: Time for Cmax (Tmax) of Sasanlimab
Phase 1b of Sub-Study A: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab
Phase 2 of Sub-Study A: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab
Phase 1b of Sub-Study A: Ctrough of Encorafenib
Phase 2 of Sub-Study A: Ctrough of Encorafenib
Phase 1b of Sub-Study A: Ctrough of Binimetinib
Phase 2 of Sub-Study A: Ctrough of Binimetinib
Phase 1b of Sub-Study A: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against Sasanlimab
In this outcome measure, number of ADA-positive and NAb-positive participants has been presented. A participant was considered ADA (or NAb) positive if (1) baseline titer was missing or negative and participant had >= 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a >= [4-fold dilution increase] in titer (equivalent to 0.602 unit increase in logarithm to base 10 (log10) titer from baseline in >= 1 post-treatment sample (treatment-boosted).
Phase 2 of Sub-Study A: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against Sasanlimab
Phase 2 of Sub-Study A: Objective Response (OR) Rate by Programmed Death Ligand-1 (PD-L1) Expression at Baseline
OR rate is defined as percentage of participants with CR or PR according to RECIST v1.1 based on investigator assessment. CR=complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR=greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. OR by PD-L1 expression at baseline was planned to be assessed.
Phase 2 of Sub-Study A: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Score
EORTC QLQ-C30: consisted of 30 questions grouped into 5 functional scales (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale; 3 symptom scales (fatigue, pain, nausea and vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea), and financial impact. All scales and single item measures ranged in score from 0 to 100. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on the functional scales represent higher levels of functioning. Higher scores on the symptom scales and single items represent a greater presence of symptoms or financial impact.
Phase 2 of Sub-Study A: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) Score
The EORTC QLQ-LC13 is the lung cancer specific module of the EORTC Quality of Life Questionnaire. The EORTC QLQ-LC13 consisted of 13 questions which included 1 multi-item scale and 9 single items assessing symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication use. The item scale ranged from 1 to 4 (1 = Not at all; 4 = Very Much) where the EORTC-QLQ-LC13 scoring algorithm was applied to convert to a 0 to 100 point scale where 100 is best quality of life (QOL), for comparability. Higher scores are reflective of a greater presence of symptoms.

Full Information

First Posted
September 30, 2020
Last Updated
July 14, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04585815
Brief Title
Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study)
Official Title
A Phase 1b/2 Open Label Umbrella Study of Sasanlimab Combined With Anti-Cancer Therapies Targeting Multiple Molecular Mechanisms in Participants With Non-Small Cell Lung Cancer (NSCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 10, 2020 (Actual)
Primary Completion Date
June 28, 2024 (Anticipated)
Study Completion Date
June 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 remains active, not recruiting, ongoing participants are still receiving treatment.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sub-Study A
Arm Type
Experimental
Arm Description
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.
Arm Title
Sub-Study B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sasanlimab Prefilled syringe
Intervention Description
prefilled syringe
Intervention Type
Drug
Intervention Name(s)
Encorafenib
Intervention Description
capsules
Intervention Type
Drug
Intervention Name(s)
Binimetinib
Intervention Description
tablets
Intervention Type
Drug
Intervention Name(s)
Sasanlimab
Intervention Description
solution supplied in vials
Intervention Type
Drug
Intervention Name(s)
Axitinib
Intervention Description
tablets
Intervention Type
Drug
Intervention Name(s)
SEA-TGT
Intervention Description
solution in vials
Primary Outcome Measure Information:
Title
Phase 1b of Sub-Study A: Percentage of Participants With Dose-Limiting Toxicities (DLT)
Description
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.
Time Frame
Day 1 up to Day 28 of Cycle 1
Title
Phase 2 of Sub-Study A: Durable Objective Response Rate (ORR)
Description
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.
Time Frame
From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy
Secondary Outcome Measure Information:
Title
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
Description
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs will be graded by the investigator according to NCI CTCAE version 5.0; where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening and Grade 5=death.
Time Frame
From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (approximately 44 months)
Title
Phase 2 of Sub-Study A: Number of Participants With Adverse Events Graded According to NCI-CTCAE Version 5.0
Description
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs were planned to be graded by the investigator according to NCI CTCAE version 5.0; where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening and Grade 5=death.
Time Frame
From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment
Title
Phase 1b of Sub-Study A: Number of Participants With Laboratory Abnormalities
Description
Following assessments will be performed: hematology: hemoglobin, platelet count, white blood cell (WBC) count, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils. Chemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate or carbon dioxide (CO2), C-reactive protein (CRP), alkaline phosphatase, sodium, potassium, magnesium chloride, total calcium, total bilirubin, total protein, blood urea nitrogen (BUN) or urea, creatinine, creatinine clearance, uric acid, glucose (random), lactate dehydrogenase, albumin, phosphorus or phosphate, amylase, lipase.
Time Frame
From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (approximately 44 months)
Title
Phase 2 of Sub-Study A: Number of Participants With Laboratory Abnormalities
Description
Hematology and clinical chemistry parameters were planned to be assessed.
Time Frame
From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment
Title
Phase 1b of Sub-Study A: Durable Objective Response Rate
Description
Durable ORR was defined as percentage of participants with confirmed CR or PR according to RECIST v1.1 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 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 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 is observed during therapy) with a minimum absolute increase of 5 mm.
Time Frame
From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy (approximately 44 months)
Title
Phase 1b of Sub-Study A: Objective Response Rate
Description
Objective response rate is defined as percentage of participants with confirmed best overall response of CR or PR according to RECIST v1.1 from the date of first dose of study treatment until the date of the first documentation of PD. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.
Time Frame
From the date of first dose of study treatment until the date of the first documentation of PD (approximately 44 months)
Title
Phase 2 of Sub-Study A: Objective Response Rate
Description
Objective response rate is defined as percentage of participants with confirmed best overall response of CR or PR according to RECIST v1.1 from the date of first dose of study treatment until the date of the first documentation of PD. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.
Time Frame
From the date of first dose of study treatment until the date of the first documentation of PD
Title
Phase 2 of Sub-Study A: Duration of Response (DR)
Description
DR was defined for participants with confirmed objective response (OR) as time from date of first documentation of OR to the date of first documentation of PD or death (any cause), whichever occurred first. OR=CR or PR according to RECIST v1.1 based on investigator assessment. CR and PR must be confirmed by repeat assessments performed no <4 weeks after criteria for response were first met. CR=complete disappearance of all target lesions (TLs) with exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR=greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions (TMLs). PD=20% increase in sum of diameters of TMLs above smallest sum observed (over baseline if no decrease in sum was observed during therapy), with a minimum absolute increase of 5 mm.
Time Frame
From the date of first documentation of OR to the date of the first documentation of PD or death due to any cause, whichever occurred first
Title
Phase 2 of Sub-Study A: Time to Tumor Response (TTR)
Description
TTR is defined for participants with confirmed objective response as the time from the date of first dose of study treatment to the date of first documentation of objective response (CR or PR) which was subsequently confirmed. CR=complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR=greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.
Time Frame
From the date of first dose of study treatment to the date of first documentation of objective response
Title
Phase 2 of Sub-Study A: Progression-Free Survival (PFS)
Description
PFS is defined as the time from the date of first dose of study treatment to the date of first documentation of PD or death due to any cause, whichever occurred first. PD=20% increase in sum of diameters of target measurable lesions above smallest sum observed (over baseline if no decrease in sum was observed during therapy), with a minimum absolute increase of 5 mm.
Time Frame
From the date of first dose of study treatment to the date of first documentation of PD or death due to any cause, whichever occurred first
Title
Phase 2 of Sub-Study A: Overall Survival (OS)
Description
OS is defined as the time from the date of first dose of study treatment to the date of death due to any cause. Participants last known to be alive were planned to be censored at the date of last contact.
Time Frame
From the date of first dose of study treatment to the date of death due to any cause or censoring date
Title
Phase 1b of Sub-Study A: Area Under the Concentration Verses Time Curve Over the Dosing Interval (AUCtau) After Single Dose of Sasanlimab
Description
AUCtau was defined as area under the plasma concentration time curve from time zero to the next dose.
Time Frame
Cycle 1 (pre-dose on Day 1, 168 hours [Day 8] and 336 hours [Day 15] and Day 28 post-dose)
Title
Phase 2 of Sub-Study A: Area Under the Concentration Verses Time Curve Over the Dosing Interval (AUCtau) After Single Dose of Sasanlimab
Time Frame
Cycle 1 (pre-dose on Day 1, 336 hours [Day 15] and Day 28 post-dose)
Title
Phase 1b of Sub-Study A: Maximum Observed Plasma Concentration (Cmax) of Sasanlimab
Time Frame
Cycle 1 (pre-dose on Day 1, 168 hours [Day 8],336 hours [Day 15] and Day 28 post-dose) and Cycle 5 (pre-dose on Day 1 and 168 hours [Day 8] post dose)
Title
Phase 2 of Sub-Study A: Maximum Observed Plasma Concentration (Cmax) of Sasanlimab
Time Frame
Cycle 1 (pre-dose on Day 1, 336 hours [Day 15] and Day 28 post-dose) and Cycle 5 Day 1 (pre-dose)
Title
Phase 1b of Sub-Study A: Time for Cmax (Tmax) of Sasanlimab
Time Frame
Cycle 1 (pre-dose on Day 1, 168 hours [Day 8], 336 hours [Day 15] and Day 28 post-dose) and Cycle 5 (pre-dose on Day 1 and 168 hours [Day 8] post dose)
Title
Phase 2 of Sub-Study A: Time for Cmax (Tmax) of Sasanlimab
Time Frame
Cycle 1 (pre-dose on Day 1, 336 hours [Day 15] and Day 28 post-dose) and Cycle 5 Day 1 (pre-dose)
Title
Phase 1b of Sub-Study A: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab
Time Frame
Cycle 5 Day 1 (pre-dose)
Title
Phase 2 of Sub-Study A: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab
Time Frame
Cycle 5 Day 1 (pre-dose)
Title
Phase 1b of Sub-Study A: Ctrough of Encorafenib
Time Frame
Cycle 5 Day 1 (pre-dose)
Title
Phase 2 of Sub-Study A: Ctrough of Encorafenib
Time Frame
Cycle 5 Day 1 (pre-dose)
Title
Phase 1b of Sub-Study A: Ctrough of Binimetinib
Time Frame
Cycle 5 Day 1 (pre-dose)
Title
Phase 2 of Sub-Study A: Ctrough of Binimetinib
Time Frame
Cycle 5 Day 1 (pre-dose)
Title
Phase 1b of Sub-Study A: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against Sasanlimab
Description
In this outcome measure, number of ADA-positive and NAb-positive participants has been presented. A participant was considered ADA (or NAb) positive if (1) baseline titer was missing or negative and participant had >= 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a >= [4-fold dilution increase] in titer (equivalent to 0.602 unit increase in logarithm to base 10 (log10) titer from baseline in >= 1 post-treatment sample (treatment-boosted).
Time Frame
Pre-dose on Cycle 1 Day 1 until end of treatment (up to approximately 255 days); each cycle is about 28 days
Title
Phase 2 of Sub-Study A: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against Sasanlimab
Time Frame
Pre-dose on Cycle 1 Day 1 until end of treatment; each cycle is about 28 days
Title
Phase 2 of Sub-Study A: Objective Response (OR) Rate by Programmed Death Ligand-1 (PD-L1) Expression at Baseline
Description
OR rate is defined as percentage of participants with CR or PR according to RECIST v1.1 based on investigator assessment. CR=complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR=greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. OR by PD-L1 expression at baseline was planned to be assessed.
Time Frame
From the date of first dose of study treatment until the date of the first documentation of PD
Title
Phase 2 of Sub-Study A: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Score
Description
EORTC QLQ-C30: consisted of 30 questions grouped into 5 functional scales (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale; 3 symptom scales (fatigue, pain, nausea and vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea), and financial impact. All scales and single item measures ranged in score from 0 to 100. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on the functional scales represent higher levels of functioning. Higher scores on the symptom scales and single items represent a greater presence of symptoms or financial impact.
Time Frame
Baseline up to end of treatment
Title
Phase 2 of Sub-Study A: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) Score
Description
The EORTC QLQ-LC13 is the lung cancer specific module of the EORTC Quality of Life Questionnaire. The EORTC QLQ-LC13 consisted of 13 questions which included 1 multi-item scale and 9 single items assessing symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication use. The item scale ranged from 1 to 4 (1 = Not at all; 4 = Very Much) where the EORTC-QLQ-LC13 scoring algorithm was applied to convert to a 0 to 100 point scale where 100 is best quality of life (QOL), for comparability. Higher scores are reflective of a greater presence of symptoms.
Time Frame
Baseline up to end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope Investigational Drug Services (IDS)
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
UCSD Medical Center - Encinitas
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
California Cancer Associates for Research and Excellence, Inc (cCARE)
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
UC San Diego Moores Cancer Center - Investigational Drug Services
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-0845
Country
United States
Facility Name
Koman Family Outpatient Pavilion
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Sulpizio Cardiovascular Center at UC San Diego Health
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UCSD Perlman Medical Offices
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Long Beach
State/Province
California
ZIP/Postal Code
90805
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90015
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UC San Diego Medical Center - Hillcrest
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
UCSD Medical Center - Vista
City
Vista
State/Province
California
ZIP/Postal Code
92081
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Facility Name
UCHealth Memorial Hospital Central
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
UCHealth Memorial Hospital North
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80920
Country
United States
Facility Name
Florida Cancer Specialists
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Florida Cancer Specialists
City
Bonita Springs
State/Province
Florida
ZIP/Postal Code
34135
Country
United States
Facility Name
Florida Cancer Specialists
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34211
Country
United States
Facility Name
Florida Cancer Specialists
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Florida Cancer Specialists
City
Cape Coral
State/Province
Florida
ZIP/Postal Code
33909
Country
United States
Facility Name
AdventHealth Celebration Infusion Center
City
Celebration
State/Province
Florida
ZIP/Postal Code
34747
Country
United States
Facility Name
AdventHealth Medical Group Oncology Research at Celebration
City
Celebration
State/Province
Florida
ZIP/Postal Code
34747
Country
United States
Facility Name
Florida Cancer Specialists
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33905
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Facility Name
Florida Cancer Specialists
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Florida Cancer Specialists
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Florida Cancer Specialists
City
Lecanto
State/Province
Florida
ZIP/Postal Code
34461
Country
United States
Facility Name
Florida Cancer Specialists
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Florida Cancer Specialists
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Florida Cancer Specialists
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Advent Health Orlando - Investigational Drug Services
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
AdventHealth Hematology and Oncology
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
AdventHealth Orlando Infusion Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Florida Cancer Specialists
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Florida Cancer Specialists
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33980
Country
United States
Facility Name
Florida Cancer Specialists
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Florida Cancer Specialists
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Florida Cancer Specialists
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34236
Country
United States
Facility Name
Florida Cancer Specialists
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34608
Country
United States
Facility Name
Florida Cancer Specialists
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Florida Cancer Specialists
City
Tavares
State/Province
Florida
ZIP/Postal Code
32778
Country
United States
Facility Name
Florida Cancer Specialists
City
The Villages
State/Province
Florida
ZIP/Postal Code
32159
Country
United States
Facility Name
Florida Cancer Specialists
City
Trinity
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Florida Cancer Specialists
City
Venice
State/Province
Florida
ZIP/Postal Code
34285
Country
United States
Facility Name
Florida Cancer Specialists
City
Venice
State/Province
Florida
ZIP/Postal Code
34292
Country
United States
Facility Name
Florida Cancer Specialists
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
University of Maryland Greenebaum Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Maryland Medical Center -IDS Pharmacy
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Ophthalmic Consultants of Boston Inc (OCB)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Henry Ford Medical Center - Fairlane
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48126
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Henry Ford Medical Center - Columbus
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Facility Name
Atlantic Health System / Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Medical Diagnostic Associates
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
Overlook Medical Center
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Mount Sinai Hospital Pharmacy
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Tennessee Oncology PLLC
City
Dickson
State/Province
Tennessee
ZIP/Postal Code
37055
Country
United States
Facility Name
Tennessee Oncology PLLC
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Tennessee Oncology PLLC
City
Gallatin
State/Province
Tennessee
ZIP/Postal Code
37066
Country
United States
Facility Name
Tennessee Oncology PLLC
City
Hendersonville
State/Province
Tennessee
ZIP/Postal Code
37075
Country
United States
Facility Name
Tennessee Oncology PLLC
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Facility Name
Tennessee Oncology PLLC
City
Lebanon
State/Province
Tennessee
ZIP/Postal Code
37090
Country
United States
Facility Name
Tennessee Oncology PLLC
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37129
Country
United States
Facility Name
Sarah Cannon Research Institute - Pharmacy
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Tennessee Oncology PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Tennessee Oncology PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Tennessee Oncology PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37207
Country
United States
Facility Name
Tennessee Oncology PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Tennessee Oncology PLLC
City
Shelbyville
State/Province
Tennessee
ZIP/Postal Code
37160
Country
United States
Facility Name
Tennessee Oncology PLLC
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States
Facility Name
Chris O'Brien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Concord Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
GenesisCare North Shore
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
North Shore Radiology and Nuclear Medicine
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Antwerp University Hospital
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Chung Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Koo Foundation Sun Yat -Sen Cancer Center
City
Taipei City
ZIP/Postal Code
112
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Koo Foundation Sun Yat-Sen Cancer Center
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Sarah Cannon Research Institute UK
City
London
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Sir Bobby Robson Cancer Trials Research Centre
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B8011011
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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