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Carcinoma, Bronchogenic

Bronchial Neoplasms

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Axitinib

Immunomodulating Agents

Protein Kinase Inhibitors

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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.

Sasanlimab Prefilled syringe

Encorafenib

Binimetinib

Sasanlimab

SEA-TGT

Pfizer CT.gov Call Center

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.

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.

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

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)

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.

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.

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.

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.

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.

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.

Hematology and clinical chemistry parameters were planned to be assessed.

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.

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.

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.

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.

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.

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.

AUCtau was defined as area under the plasma concentration time curve from time zero to the next dose.

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).

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.

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.

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.

Pfizer

Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.

Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.

Phase 1b: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg)

Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.

Phase 1b: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Full analysis set included all participants who received at least 1 dose of study drug. Participants were classified according to the treatment actually received.

A DLT of Grade 4 respiratory failure which occurred in 1 participant that led to death following completion of the DLT observation period (and after the primary completion date) is not included in results of outcome measure 1. It will be captured and reported when results are posted at study completion date.

Pfizer ClinicalTrials.gov Call Center

DLT-evaluable analysis set included all participants who received at least 1 dose of study treatment in Phase 1b and either experienced DLT during the DLT-observation period or completed the DLT-observation period without DLT.

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

Participants with NSCLC with BRAFV600 mutations were planned to receive a combination of sasanlimab encorafenib and binimetinib at the recommended Phase 2 dose.

Phase 2: Sasanlimab + Encorafenib + Binimetinib

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.

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

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

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

Phase 1b of Sub-Study A: Number of Participants With Laboratory Abnormalities

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

Phase 1b of Sub-Study A: Durable Objective Response Rate

Phase 1b of Sub-Study A: Objective Response Rate

Phase 2 of Sub-Study A: Objective Response Rate

Phase 2 of Sub-Study A: Duration of Response (DR)

Participants with NSCLC with BRAFV600 mutations were planned to receive a combination of sasanlimab, encorafenib and binimetinib at the recommended Phase 2 dose.

Phase 2 of Sub-Study A: Time to Tumor Response (TTR)

Phase 2 of Sub-Study A: Progression-Free Survival (PFS)

Phase 2 of Sub-Study A: Overall Survival (OS)

Pharmacokinetic (PK) parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug (i.e., sasanlimab). Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Phase 1b of Sub-Study A: Area Under the Concentration Verses Time Curve Over the Dosing Interval (AUCtau) After Single Dose of Sasanlimab

Phase 2 of Sub-Study A: Area Under the Concentration Verses Time Curve Over the Dosing Interval (AUCtau) After Single Dose of Sasanlimab

Cycle 1

Cycle 5

PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug (i.e., sasanlimab). Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

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

PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug (i.e., sasanlimab). Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

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

Immunogenicity analysis set was a subset of the safety analysis set (participants who received at least 1 dose of study drug) and included participants who had at least 1 analyzed sasanlimab ADA/NAb sample. All participants included in 'Overall Number of Participants Analyzed' contributed data to the table. Here, 'Number Analyzed' signifies participants evaluated for ADA and NAb respectively.

Phase 1b 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: 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

Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and there was no data collection for it.

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

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

Spots Global Cancer Trial Database for ecog 1

Every month we try and update this database with for ecog 1 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ecog 1

Every month we try and update this database with for ecog 1 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ecog 1 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.