Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04585815
Other study ID # B8011011
Secondary ID 2020-002829-28
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date November 10, 2020
Est. completion date June 17, 2024

Study information

Verified date April 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 34
Est. completion date June 17, 2024
Est. primary completion date May 17, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria Umbrella Phase 1b & 2: - Histologically or cytologically confirmed locally advanced/metastatic (Stage IIIB-IV) NSCLC. - At least one measurable lesion per RECIST v1.1 at Screening. - ECOG Performance Status 0 or 1. - Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade =1. - Adequate hepatic, renal, and bone marrow function. Additional Inclusion Criteria for Sub-Study A Phase 1b &2: -BRAFV600E mutation in tumor tissue or plasma as determined by a local laboratory PCR or NGS assay and documented in a local pathology report. Additional Inclusion Criteria for Sub-Study A Phase 1b only: -Any line of therapy for locally advanced/metastatic NSCLC. Additional Inclusion Criteria for Sub-Study A Phase 2 only: -Previously untreated for locally advanced/metastatic NSCLC Additional Inclusion Criteria for Sub-Study B Phase 1b only:: -Any line of therapy for locally advanced/metastatic NSCLC. Additional Inclusion Criteria for Sub-Study B Phase 2 only: - Previously untreated for locally advanced/metastatic NSCLC (Arms B1 & B2), or - One or 2 prior lines of therapy for advanced/metastatic NSCLC (Arm B3), including immune checkpoint inhibitor treatment + chemotherapy, and have progressed during or after that therapy. - PD-L1 TPS =1% Exclusion Criteria Umbrella Phase 1b &2: - Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent. - Active non-infectious pneumonitis, pulmonary fibrosis, or known history of immune-mediated pneumonitis. - Active infection requiring systemic therapy. - Clinically significant cardiovascular disease. - Other malignancy within 2 years of first dose, with exceptions. - Symptomatic brain metastasis, with exceptions. Additional Exclusion Criteria for Sub-Study A Phase 1b&2: - EGFR mutation, ALK fusion oncogene, or ROS1 rearrangement. - Prior treatment with any BRAF inhibitor or MEK inhibitor. Additional Exclusion Criteria for Sub-Study A Phase 2 only: -Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents. Additional Exclusion Criteria for Sub-Study B Phase 1b&2: -Documentation of any tumor-driving molecular alteration (eg, BRAF, EGFR, ALK) Additional Exclusion Criteria for Sub-Study B Phase 2 only: - Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.(Arms B1 & B2) - Confirmed progressive disease on 1st or 2nd imaging tumor assessment after initiation of therapy for advanced/metastatic NSCLC.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sasanlimab Prefilled syringe
prefilled syringe
Encorafenib
capsules
Binimetinib
tablets
Sasanlimab
solution supplied in vials
Axitinib
tablets
SEA-TGT
solution in vials

Locations

Country Name City State
Australia Chris O'Brien Lifehouse Camperdown New South Wales
Australia Concord Hospital Concord New South Wales
Australia Austin Health Heidelberg Victoria
Australia GenesisCare North Shore St Leonards New South Wales
Australia North Shore Radiology and Nuclear Medicine St Leonards New South Wales
Belgium Antwerp University Hospital Edegem Antwerpen
Belgium UZ Gent Gent
Belgium UZ Leuven Leuven
Taiwan Chung Shan Medical University Hospital Taichung
Taiwan Koo Foundation Sun Yat-Sen Cancer Center Taipei
Taiwan National Taiwan University Hospital Taipei
Taiwan Koo Foundation Sun Yat -Sen Cancer Center Taipei City
Taiwan National Taiwan University Hospital Taipei City
United Kingdom Sarah Cannon Research Institute UK London
United Kingdom Royal Victoria Infirmary Newcastle upon Tyne
United Kingdom Sir Bobby Robson Cancer Trials Research Centre Newcastle upon Tyne
United States Florida Cancer Specialists Altamonte Springs Florida
United States University of Maryland Greenebaum Comprehensive Cancer Center Baltimore Maryland
United States University of Maryland Medical Center -IDS Pharmacy Baltimore Maryland
United States Florida Cancer Specialists Bonita Springs Florida
United States Massachusetts General Hospital Boston Massachusetts
United States Ophthalmic Consultants of Boston Inc (OCB) Boston Massachusetts
United States Florida Cancer Specialists Bradenton Florida
United States Florida Cancer Specialists Brandon Florida
United States Florida Cancer Specialists Cape Coral Florida
United States AdventHealth Celebration Infusion Center Celebration Florida
United States AdventHealth Medical Group Oncology Research at Celebration Celebration Florida
United States Florida Cancer Specialists Clearwater Florida
United States UCHealth Memorial Hospital Central Colorado Springs Colorado
United States UCHealth Memorial Hospital North Colorado Springs Colorado
United States Henry Ford Medical Center - Fairlane Dearborn Michigan
United States Henry Ford Hospital Detroit Michigan
United States Tennessee Oncology PLLC Dickson Tennessee
United States City of Hope Duarte California
United States City of Hope Investigational Drug Services (IDS) Duarte California
United States UCSD Medical Center - Encinitas Encinitas California
United States Florida Cancer Specialists Fort Myers Florida
United States Florida Cancer Specialists Fort Myers Florida
United States Florida Cancer Specialists Fort Myers Florida
United States Tennessee Oncology PLLC Franklin Tennessee
United States California Cancer Associates for Research and Excellence, Inc (cCARE) Fresno California
United States Florida Cancer Specialists Gainesville Florida
United States Tennessee Oncology PLLC Gallatin Tennessee
United States The Oncology Institute of Hope and Innovation Glendale California
United States Tennessee Oncology PLLC Hendersonville Tennessee
United States Tennessee Oncology PLLC Hermitage Tennessee
United States Koman Family Outpatient Pavilion La Jolla California
United States Sulpizio Cardiovascular Center at UC San Diego Health La Jolla California
United States UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) La Jolla California
United States UC San Diego Moores Cancer Center La Jolla California
United States UC San Diego Moores Cancer Center - Investigational Drug Services La Jolla California
United States UCSD Perlman Medical Offices La Jolla California
United States Florida Cancer Specialists Largo Florida
United States Tennessee Oncology PLLC Lebanon Tennessee
United States Florida Cancer Specialists Lecanto Florida
United States The Oncology Institute of Hope and Innovation Long Beach California
United States The Oncology Institute of Hope and Innovation Los Angeles California
United States USC/Norris Comprehensive Cancer Center Los Angeles California
United States Atlantic Health System / Morristown Medical Center Morristown New Jersey
United States Morristown Medical Center Morristown New Jersey
United States Tennessee Oncology PLLC Murfreesboro Tennessee
United States Florida Cancer Specialists Naples Florida
United States Sarah Cannon Research Institute - Pharmacy Nashville Tennessee
United States Tennessee Oncology PLLC Nashville Tennessee
United States Tennessee Oncology PLLC Nashville Tennessee
United States Tennessee Oncology PLLC Nashville Tennessee
United States Tennessee Oncology PLLC Nashville Tennessee
United States Icahn School of Medicine at Mount Sinai New York New York
United States Mount Sinai Hospital Pharmacy New York New York
United States Henry Ford Medical Center - Columbus Novi Michigan
United States Florida Cancer Specialists Ocala Florida
United States Florida Cancer Specialists Orange City Florida
United States Advent Health Orlando - Investigational Drug Services Orlando Florida
United States AdventHealth Orlando Orlando Florida
United States AdventHealth Orlando Infusion Center Orlando Florida
United States Florida Cancer Specialists Orlando Florida
United States Florida Cancer Specialists Port Charlotte Florida
United States Florida Cancer Specialists Saint Petersburg Florida
United States UC San Diego Medical Center - Hillcrest San Diego California
United States The Oncology Institute of Hope and Innovation Santa Ana California
United States Florida Cancer Specialists Sarasota Florida
United States Florida Cancer Specialists Sarasota Florida
United States Tennessee Oncology PLLC Shelbyville Tennessee
United States Tennessee Oncology PLLC Smyrna Tennessee
United States Florida Cancer Specialists Spring Hill Florida
United States Medical Diagnostic Associates Summit New Jersey
United States Overlook Medical Center Summit New Jersey
United States Florida Cancer Specialists Tampa Florida
United States Moffitt Cancer Center Tampa Florida
United States Florida Cancer Specialists Tavares Florida
United States Florida Cancer Specialists The Villages Florida
United States Florida Cancer Specialists Trinity Florida
United States Florida Cancer Specialists Venice Florida
United States Florida Cancer Specialists Venice Florida
United States UCSD Medical Center - Vista Vista California
United States The Oncology Institute of Hope and Innovation Whittier California
United States Florida Cancer Specialists Winter Park Florida

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phase 1b of Sub-Study A: Percentage of Participants With Dose-Limiting Toxicities (DLT) DLT=AEs in DLT observation period (OP) related to any study intervention:Grade (G)4 neutropenia;thrombocytopenia or anemia;febrile neutropenia;neutropenic infection;G3 thrombocytopenia with bleeding. Any G>=3 toxicity (except transient G3 fatigue, local reactions/headache that resolved to G<=1/baseline; G3 nausea, vomiting controlled within 72 hrs, G3 hypertension controlled by medical therapy (MT), G3 diarrhea that improved to G<=2 within 72 hrs, G3 skin toxicity that resolved to G<=1 in <7 days after MT, G3 endocrinopathies controlled by MT and tumors flare); Non-hematologic G3 lab abnormality [LA](medical intervention or hospitalization), or any G4 LA;ALT/AST>3*ULN (normal at baseline) or >3*ULN and doubling baseline (>ULN at baseline) and associated with total bilirubin(TB) >2*ULN;or ALT/AST>5*ULN; or TB>3*ULN. Missing 75% of planned doses during DLT OP due to treatment-related toxicities. AE not listed/DLT criteria outside DLT OP was DLT at discretion of sponsor and investigator. Day 1 up to Day 28 of Cycle 1
Primary Phase 2 of Sub-Study A: Durable Objective Response Rate (ORR) Durable ORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 based on investigator assessment, lasting for at least 10 months from the date of first CR or PR until the date of the first documentation of disease progression (PD), death, or start of new anticancer therapy. CR was defined as complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10 millimeter [mm]). PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. PD was defined as 20% increase in sum of diameters of target measurable lesions above smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy
Secondary 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. From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (approximately 44 months)
Secondary 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. From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment
Secondary 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. From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (approximately 44 months)
Secondary Phase 2 of Sub-Study A: Number of Participants With Laboratory Abnormalities Hematology and clinical chemistry parameters were planned to be assessed. From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment
Secondary 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. 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)
Secondary 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. From the date of first dose of study treatment until the date of the first documentation of PD (approximately 44 months)
Secondary 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. From the date of first dose of study treatment until the date of the first documentation of PD
Secondary 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. 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
Secondary 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. From the date of first dose of study treatment to the date of first documentation of objective response
Secondary 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. 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
Secondary 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. From the date of first dose of study treatment to the date of death due to any cause or censoring date
Secondary 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. Cycle 1 (pre-dose on Day 1, 168 hours [Day 8] and 336 hours [Day 15] and Day 28 post-dose)
Secondary 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 (pre-dose on Day 1, 336 hours [Day 15] and Day 28 post-dose)
Secondary Phase 1b of Sub-Study A: Maximum Observed Plasma Concentration (Cmax) of Sasanlimab 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)
Secondary Phase 2 of Sub-Study A: Maximum Observed Plasma Concentration (Cmax) of Sasanlimab Cycle 1 (pre-dose on Day 1, 336 hours [Day 15] and Day 28 post-dose) and Cycle 5 Day 1 (pre-dose)
Secondary Phase 1b of Sub-Study A: Time for Cmax (Tmax) of Sasanlimab 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)
Secondary Phase 2 of Sub-Study A: Time for Cmax (Tmax) of Sasanlimab Cycle 1 (pre-dose on Day 1, 336 hours [Day 15] and Day 28 post-dose) and Cycle 5 Day 1 (pre-dose)
Secondary Phase 1b of Sub-Study A: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab Cycle 5 Day 1 (pre-dose)
Secondary Phase 2 of Sub-Study A: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab Cycle 5 Day 1 (pre-dose)
Secondary Phase 1b of Sub-Study A: Ctrough of Encorafenib Cycle 5 Day 1 (pre-dose)
Secondary Phase 2 of Sub-Study A: Ctrough of Encorafenib Cycle 5 Day 1 (pre-dose)
Secondary Phase 1b of Sub-Study A: Ctrough of Binimetinib Cycle 5 Day 1 (pre-dose)
Secondary Phase 2 of Sub-Study A: Ctrough of Binimetinib Cycle 5 Day 1 (pre-dose)
Secondary 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). Pre-dose on Cycle 1 Day 1 until end of treatment (up to approximately 255 days); each cycle is about 28 days
Secondary Phase 2 of Sub-Study A: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against Sasanlimab Pre-dose on Cycle 1 Day 1 until end of treatment; each cycle is about 28 days
Secondary 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. From the date of first dose of study treatment until the date of the first documentation of PD
Secondary 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. Baseline up to end of treatment
Secondary 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. Baseline up to end of treatment
See also
  Status Clinical Trial Phase
Completed NCT04879849 - A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers Phase 1
Completed NCT04426825 - A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer Phase 2
Terminated NCT03166631 - A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread Phase 1
Completed NCT02810457 - Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer Phase 3
Completed NCT02864394 - Study of Pembrolizumab Versus Docetaxel in Participants Previously Treated for Non-Small Cell Lung Cancer (MK-3475-033/KEYNOTE-033) Phase 3
Recruiting NCT04592523 - A Study of Usage of Brigatinib in the Treatment of Adult Participants for Approved Indications In South Korea
Recruiting NCT04838548 - A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer Phase 2
Recruiting NCT04077463 - A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer Phase 1
Recruiting NCT05167604 - Clinical Value of MRD Monitoring for Adjuvant Therapy in Postoperative NSCLC
Recruiting NCT04603807 - A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases Phase 3
Completed NCT04948411 - Durvalumab as Maintenance in Patients Who Received Chemoradiotherapy for Unresectable Stage III NSCLC: Real World Data From an Expanded Access Program in Brazil
Active, not recruiting NCT04487080 - A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer Phase 3
Not yet recruiting NCT04255836 - Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC) Phase 2
Completed NCT01953913 - Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation Phase 3
Recruiting NCT05715229 - Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy Phase 2
Recruiting NCT04931654 - A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer Phase 1/Phase 2
Suspended NCT05421936 - Osimertinib for NSCLC With Uncommon EGFR Mutations
Completed NCT02847377 - A Positron Emission Tomography (PET) Imaging Agent [18F]-ODS2004436 as a Marker of EGFR Mutation in Subjects With NSCLC N/A
Completed NCT04427072 - Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation Phase 3
Recruiting NCT04823377 - Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer. N/A