Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Phase 3 – large-scale trial before approval
Conditions:
Advanced Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Carcinoma, Non-Small-Cell Lung (NSCLC)
Metastatic Non Small Cell Lung Cancer
Lung Cancer
Sponsor: Pfizer
trial.available_in:
БГ
Overview
This study is being done to find out if a new medicine called PF-08634404, when given with chemotherapy, works better than the present standard treatment (pembrolizumab with chemotherapy) for adults with a type of lung cancer called non-small cell lung cancer (NSCLC) that is either locally advanced (spread to nearby tissues) or has spread to other parts of the body.
To join the study, participants must meet the following conditions:
* Be 18 years or older.
* Have locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC.
* Is not a candidate for complete surgical resection or curative chemoradiotherapy.
* Do not have known actionable genomic alterations
* Be treatment naïve for advanced or metastatic disease
Participants in this study will be assigned to two different parts of the study depending on their type of tumor: participants with squamous NSCLC will be assigned to Part 1, while participants with non-squamous NSCLC will be assigned to Part 2.
Each participant will be randomly assigned (like a flip of the coin) to one of two treatment groups in a blinded fashion:
* Part 1 - Arm A or Part 2 - Arm C (Experimental Group): Will receive a new study medicine called PF-08634404 along with a kind of chemotherapy specific to the type of tumor.
* Part 1 - Arm B or Part 2 - Arm D (Control Group): Will receive an approved medicine called pembrolizumab along with a kind of chemotherapy specific to the type of tumor.
Participants will receive their assigned treatment through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, participants will receive PF-08634404 or Pembrolizumab in combination with chemotherapy followed by maintenance with either PF-08634404 or Pembrolizumab monotherapy (Part 1) or PF-08634404 or Pembrolizumab in combination with a chemotherapeutic drug (Part 2). Participants will continue receiving treatment if it is helping and not experiencing serious side effects.
The study will include regular visits for:
* Treatment and health checks: while participant continues receiving treatment.
* Tests to monitor how cancer responds: every 6 weeks during the first 48 weeks, then every 12 weeks thereafter.
Who can participate
Inclusion Criteria:
* 18 years of age or older at screening.
* Have pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV)squamous or non-squamous NSCLC and not be a candidate for complete surgical resection and curative concurrent/sequential chemoradiotherapy (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer Tumor, lymph nodes, metastasis (TNM) staging system).
* Have tumor tissue available, either paraffin block or slides from a core, excisional or fine needle biopsy
* PD-L1 status available based on local testing results
* Measurable disease based on RECIST v1.1 per investigator.
* Eastern Cooperative Oncology Group performance status (ECOG) score of 0 or 1
* Expected survival ≥12 weeks
Exclusion Criteria:
* Participants with known actionable genomic alteration (AGAs), including estimated glomerular filtration rate (EGFR), anaplastic lymphoma kinase (ALK), Repressor of Silencing 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), v-raf murine sarcoma viral oncogene homolog B1 (BRAF), rearranged during transfection (RET), and mesenchymal-epithelial transition (MET), for which there are available first-line therapies per local standard-of-care (SOC) are ineligible. Documented negative results for EGFR, ALK, and ROS1 AGAs are required for participants with non-squamous histology.
* Known active CNS lesions are excluded. Participants with definitively treated brain metastases (surgery and/or radiotherapy) may be eligible. Clinically inactive brain metastases of longest diameter \< 1 cm are permitted.
* Participants with clinically significant risk of hemorrhage or fistula are excluded.
* Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
* Unresolved toxicities from prior anti-tumor therapy, that did not recover to NCI CTCAE v5.0 Grade 0 or 1.
* Known to have a history of a severe allergy to any component of the study intervention, or a history of severe allergic reaction to chimeric or humanized antibody.
* History of allogeneic organ / hematopoietic stem cell transplantation.
* Participants with any of the following respiratory conditions:
* Evidence of noninfectious or drug-induced interstitial lung disease (ILD) or pneumonitis
* Grade ≥3 pulmonary disease unrelated to underlying malignancy
* History of uncontrolled comorbidities within 6 months prior to the first dose including uncontrolled cardiac and cerebrovascular conditions, hypertension, diabetes, significant vascular disease or arterial/severe venous thromboembolic events.
* Major surgery \< 4 weeks or minor surgery \< 3 days prior to first dose of study intervention.
* History of severe bleeding tendency or coagulation dysfunction
* History of esophageal varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose.
* Participants with acute, chronic or symptomatic infections including participants positive for active HIV, hepatitis B virus (HBV), or Hepatitis C virus (HCV).
* Participants with history of immunodeficiency
* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior (in the past 5 years) or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.
* Previous systemic anti-tumor therapy including:
1. Prior systemic therapy, including anti-PD-(L)1 therapy, for locally advanced, unresectable, or metastatic NSCLC.
2. Previous treatment with immunotherapy
3. Prior radiotherapy \> 30 Gy to the lung \< 6 months of first dose of study intervention
4. Palliative local therapy \< 2 weeks before the first dose of study intervention;
5. Non-specific immunomodulatory therapy \< 2 weeks before the first dose.
6. Prior systemic anti-angiogenic therapy
* Prior immune-related AE that led to anti-PD-(L)1 treatment discontinuation, adverse events from prior immunotherapy not improved to Grade 1 before screening, or required treatment with systemic immunosuppressive therapy.
* Prior and concomitant therapy:
1. therapeutic oral or parenteral anticoagulants or thrombolytic agents \< 10 days to the first dose.
2. chronic antiplatelet therapy \<7 days to randomization.
3. live or attenuated live vaccine \< 4 weeks to the first dose.
4. current high-dose systemic corticosteroids.
5. prohibited concomitant medication(s) \< 21 days to the first dose.
* Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.
Interventions
PF-08634404
BIOLOGICAL
Pembrolizumab
BIOLOGICAL
Chemotherapy Regimen 1
DRUG
Chemotherapy Regimen 2
DRUG
Locations
229
Argentina (6)
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires
NOT_YET_RECRUITING
Investigaciones Clinicas Moleculares (ICM)
CABA , Buenos Aires
NOT_YET_RECRUITING
Clinica Adventista Belgrano
CABA , Buenos Aires F.D.
NOT_YET_RECRUITING
Instituto Argentino de Diagnóstico y Tratamiento (IADT)
Ciudad Autónoma de Buenos Aires , Buenos Aires
NOT_YET_RECRUITING
Hospital Italiano de Córdoba
Córdoba , Córdoba Province
NOT_YET_RECRUITING
Fundación CORI para la Investigación y Prevención del Cáncer
La Rioja
NOT_YET_RECRUITING
Australia (5)
Sunshine Coast University Hospital
Birtinya , Queensland
Gympie Hospital
Gympie , Queensland
Icon Cancer Centre Hobart
Hobart , Tasmania
St Vincent's Hospital
Melbourne , Victoria
NOT_YET_RECRUITING
Nambour General Hospital
Nambour , Queensland
Canada (3)
Arthur J.E. Child Comprehensive Cancer Centre
Calgary , Alberta
NOT_YET_RECRUITING
McGill University Health Centre
Montreal , Quebec
NOT_YET_RECRUITING
Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎ
Montreal , Quebec
NOT_YET_RECRUITING
China (2)
Shanghai East Hospital
Shanghai
NOT_YET_RECRUITING
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan
NOT_YET_RECRUITING
Czech Republic (2)
Nemocnice AGEL Ostrava - Vitkovice a.s.
Ostrava
NOT_YET_RECRUITING
Fakultni Thomayerova nemocnice
Prague
NOT_YET_RECRUITING
France (3)
Institut de Cancérologie de l'Ouest
Angers , Maine ET Loire
NOT_YET_RECRUITING
Hôpital Ambroise Paré
Boulogne-Billancourt , Île-de-France Region
NOT_YET_RECRUITING
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
Limoges , Haute Vienne
NOT_YET_RECRUITING
India (5)
KLES Dr. Prabhakar Kore Hospital & M.R.C
Belagavi , Karnataka
NOT_YET_RECRUITING
Apex Wellness Hospital
Nashik , Maharashtra
NOT_YET_RECRUITING
Sahyadri Super Speciality Hospital
Pune , Maharashtra
NOT_YET_RECRUITING
Nirmal Hospital Pvt Ltd.
Surat , Gujarat
NOT_YET_RECRUITING
Bhakti Vedanta Hospital and Research Institute
Thane , Maharashtra
NOT_YET_RECRUITING
Israel (5)
Shaare Zedek Medical Center
Jerusalem , Jerusalem
Hadassah Medical Center
Jerusalem , Jerusalem
Sheba Medical Center
Ramat Gan , HA Merkaz
NOT_YET_RECRUITING
Sourasky Medical Center
Tel Aviv , TELL ABĪB
Yitzhak Shamir Medical Center
Ẕerifin , HA Merkaz
NOT_YET_RECRUITING
Japan (21)
National Hospital Organization Beppu Medical Center
Beppu , Oita Prefecture
NOT_YET_RECRUITING
Nippon Medical School Hospital
Bunkyo-ku , Tokyo
National Cancer Center Hospital
Chuo-ku , Tokyo
National Hospital Organization Kyushu Cancer Center
Fukuoka
NHO Mito Medical Center
Higashiibaraki , Ibaraki
NOT_YET_RECRUITING
Kansai Medical University Hospital
Hirakata-shi , Osaka
National Hospital Organization Kanazawa Medical Center
Kanazawa , Ishikawa-ken
NOT_YET_RECRUITING
National Hospital Organization Tokyo National Hospital
Kiyose , Tokyo
NOT_YET_RECRUITING
Kobe Minimally Invasive Cancer Center
Kobe , Hyōgo
Kobe City Medical Center General Hospital
Kobe , Hyōgo
NOT_YET_RECRUITING
National Hospital Organization Kochi National Hospital
Kochi
National Hospital Organization Kyoto Medical Center
Kyoto
National Hospital Organization Shikoku Cancer Center
Matsuyama , Ehime
NOT_YET_RECRUITING
National Hospital Organization Okayama Medical Center
Okayama
National Hospital Organization Nagasaki Medical Center
Ōmura , Nagasaki
Gunma Prefectural Cancer Center
Otashi , Gunma
Hokkaido University Hospital
Sapporo , Hokkaido
National Center for Global Health and Medicine
Shinjyuku-ku , Tokyo
NOT_YET_RECRUITING
The University of Osaka Hospital
Suita , Osaka
Mie Chuo Medical Center
Tsu , Mie-ken
National Hospital Organization Yamaguchi Ube Medical Center
Ube , Yamaguchi
NOT_YET_RECRUITING
Puerto Rico (3)
Pan American Center for Oncology Trials, LLC- Dorado Office
Dorado
Pan American Center for Oncology Trials, LLC
Rio Piedras
BRCR Global Puerto Rico - Hato Rey
San Juan
Spain (10)
Parc de Salut Mar - Hospital del Mar
Barcelona , Barcelona [barcelona]
NOT_YET_RECRUITING
Hospital Universitari Vall d'Hebron
Barcelona , Barcelona [barcelona]
NOT_YET_RECRUITING
Hospital General Universitario de Elche
Elche , Alicante
NOT_YET_RECRUITING
Institut Català d'Oncologia (ICO) - Girona
Girona , Girona [gerona]
NOT_YET_RECRUITING
Hospital Universitario San Cecilio
Granada
NOT_YET_RECRUITING
Hospital Universitario Juan Ramon Jimenez
Huelva
NOT_YET_RECRUITING
Hospital Jerez de la Frontera
Jerez de la Frontera , Cádiz
NOT_YET_RECRUITING
Hospital Universitario 12 de Octubre
Madrid , Madrid, Comunidad de
NOT_YET_RECRUITING
Hospital Universitario Fundación Jiménez Díaz
Madrid
NOT_YET_RECRUITING
Hospital Universitari Son Espases
Palma
NOT_YET_RECRUITING
Taiwan (7)
Changhua Christian Hospital
Changhua County , Changhua
National Taiwan University Hospital - Hsinchu branch
Hsinchu
NOT_YET_RECRUITING
Chung Shan Medical University Hospital
Taichung
NOT_YET_RECRUITING
National Cheng Kung University Hospital
Tainan
NOT_YET_RECRUITING
National Taiwan University Hospital
Taipei
NOT_YET_RECRUITING
Taipei Medical University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
NOT_YET_RECRUITING
Turkey (6)
Adana Medical Park Seyhan Hastanesi
Adana
NOT_YET_RECRUITING
Dicle Üniversitesi
Diyarbakır
NOT_YET_RECRUITING
Istinye University - Liv Hospital - Topkapi
Istanbul , İstanbul
NOT_YET_RECRUITING
Medipol Mega Universite Hastanesi
Istanbul , İstanbul
NOT_YET_RECRUITING
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul , İstanbul
NOT_YET_RECRUITING
Samsun Medical Park Hastanesi
Samsun
NOT_YET_RECRUITING
United States (151)
Texas Oncology - West Texas
Abilene , Texas
New York Oncology Hematology
Albany , New York
Texas Oncology - Northeast Texas
Allen , Texas
Texas Oncology - West Texas
Amarillo , Texas
Los Angeles Cancer Network - Anaheim
Anaheim , California
Maryland Oncology Hematology, P.A.
Annapolis , Maryland
Illinois Cancer Specialists
Arlington Heights , Illinois
Texas Oncology - Central/South Texas
Austin , Texas
Texas Oncology - Gulf Coast
Beaumont , Texas
Maryland Oncology Hematology, P.A.
Bethesda , Maryland
Illinois CancerCare - Bloomington
Bloomington , Illinois
Florida Cancer Specialists
Bonita Springs , Florida
Florida Cancer Specialists
Bradenton , Florida
Maryland Oncology Hematology, P.A.
Brandywine , Maryland
Pioneer Research Center
Bullhead City , Arizona
Minnesota Oncology Hematology, P.A.
Burnsville , Minnesota
Florida Cancer Specialists
Cape Coral , Florida
Ironwood Cancer & Research Centers
Chandler , Arizona
Minnesota Oncology Hematology, P.A.
Chaska , Minnesota
Tennessee Oncology, PLLC - Chattanooga Downtown
Chattanooga , Tennessee
Tennessee Oncology, PLLC - Chattanooga - Medical Park II
Chattanooga , Tennessee
Oncology Hematology Care Clinical Trials
Cincinnati , Ohio
Oncology Hematology Care Clinical Trials
Cincinnati , Ohio
Oncology Hematology Care Clinical Trials
Cincinnati , Ohio
Florida Cancer Specialists
Clearwater , Florida
New York Oncology Hematology
Clifton Park , New York
Maryland Oncology Hematology - Columbia
Columbia , Maryland
Minnesota Oncology Hematology, P.A.
Coon Rapids , Minnesota
BRCR Global- Coral Springs
Coral Springs , Florida
Florida Cancer Specialists
Daytona Beach , Florida
Texas Oncology - Northeast Texas
Denison , Texas
Texas Oncology - Northeast Texas
Denton , Texas
Minnesota Oncology Hematology, P.A.
Edina , Minnesota
Texas Oncology - West Texas
El Paso , Texas
Texas Oncology - West Texas
El Paso , Texas
Texas Oncology - West Texas
El Paso , Texas
Oncology Hematology Care Clinical Trials
Fairfield , Ohio
Highlands Oncology Group
Fayetteville , Arkansas
Florida Cancer Specialists
Fleming Island , Florida
Texas Oncology - Northeast Texas
Flower Mound , Texas
Helios Clinical Research
Fort Lauderdale , Florida
Florida Cancer Specialists - South
Fort Myers , Florida
Florida Cancer Specialists
Fort Myers , Florida
Florida Cancer Specialists
Fort Myers , Florida
Orange Coast Memorial Medical Center
Fountain Valley , California
NOT_YET_RECRUITING
Los Angeles Cancer Network - Fountain Valley
Fountain Valley , California
Memorial Care Orange Coast Medical Center Attn
Fountain Valley , California
NOT_YET_RECRUITING
OC Blood and Cancer Care
Fountain Valley , California
NOT_YET_RECRUITING
Orange Coast Memorial Medical Center
Fountain Valley , California
NOT_YET_RECRUITING
Tennessee Oncology, PLLC - Franklin
Franklin , Tennessee
Florida Cancer Specialists
Gainesville , Florida
Illinois CancerCare - Galesburg
Galesburg , Illinois
Tennessee Oncology, PLLC - Gallatin
Gallatin , Tennessee
Maryland Oncology Hematology, P.A.
Germantown , Maryland
Ironwood Cancer & Research Centers
Gilbert , Arizona
Ironwood Cancer & Research Centers
Glendale , Arizona
Ironwood Cancer & Research Centers
Goodyear , Arizona
Texas Oncology - Central/South Texas
Harlingen , Texas
Hope and Healing Cancer Services
Hinsdale , Illinois
Texas Oncology - Gulf Coast
Houston , Texas
Texas Oncology - Gulf Coast
Houston , Texas
Texas Oncology - Gulf Coast
Houston , Texas
Minnesota Oncology Hematology, P.A.
Hudson , Wisconsin
Texas Oncology - Gulf Coast
Humble , Texas
US Oncology Investigational Products Center (IPC)
Irving , Texas
US Oncology Investigational Products Center
Irving , Texas
Tennessee Cancer Specialists Dowell Springs location
Knoxville , Tennessee
Memorial Care Saddleback Medical Center Attn
Laguna Hills , California
NOT_YET_RECRUITING
Maryland Oncology Hematology, P.A.
Largo , Maryland
Florida Cancer Specialists
Largo , Florida
Tennessee Oncology, PLLC - Lebanon
Lebanon , Tennessee
Florida Cancer Specialists
Lecanto , Florida
Texas Oncology - Northeast Texas
Lewisville , Texas
NHO Revive Research Institute, LLC
Lincoln , Nebraska
NOT_YET_RECRUITING
Cancer Partners of Nebraska - April Sampson Cancer Center
Lincoln , Nebraska
Memorial Care Long Beach Medical Center
Long Beach , California
NOT_YET_RECRUITING
Texas Oncology - Northeast Texas
Longview , Texas
Los Angeles Cancer Network - Good Samaritan
Los Angeles , California
Minnesota Oncology Hematology, P.A.
Maple Grove , Minnesota
Minnesota Oncology Hematology, P.A.
Maplewood , Minnesota
Texas Oncology - Central/South Texas
McAllen , Texas
Texas Oncology - Northeast Texas
McKinney , Texas
Ironwood Cancer & Research Centers
Mesa , Arizona
Ironwood Cancer & Research Centers
Mesa , Arizona
Texas Oncology - West Texas
Midland , Texas
Tennesseee Oncology, PLLC - Mount Juliet
Mount Juliet , Tennessee
Tennessee Oncology, PLLC - Murfreesboro
Murfreesboro , Tennessee
Florida Cancer Specialists
N. Venice , Florida
Florida Cancer Specialists
Naples , Florida
SCRI Oncology Partners
Nashville , Tennessee
Tennessee Oncology, PLLC-Elliston Place Plaza Medical Oncology &Hematology
Nashville , Tennessee
Tennessee Oncology, PLLC - Saint Thomas West
Nashville , Tennessee
Hope and Healing Cancer Services
New Lenox , Illinois
Hematology Oncology Associates of Rockland
Nyack , New York
Florida Cancer Specialists
Ocala , Florida
Texas Oncology - West Texas
Odessa , Texas
Florida Cancer Specialists
Orange City , Florida
Mid Florida Hematology and Oncology Center
Orange City , Florida
Florida Cancer Specialists
Orlando , Florida
Orlando Health Ambulatory Care Center
Orlando , Florida
NOT_YET_RECRUITING
Orlando Health Cancer Institute
Orlando , Florida
NOT_YET_RECRUITING
Orlando Health Orlando Regional Medical Center
Orlando , Florida
NOT_YET_RECRUITING
Illinois CancerCare-Ottawa-Fox River Cancer Center
Ottawa , Illinois
Texas Oncology - Northeast Texas
Palestine , Texas
Cancer Care Centers of Brevard, Inc.
Palm Bay , Florida
Florida Cancer Specialists
Palm Beach Gardens , Florida
Texas Oncology - Northeast Texas
Paris , Texas
Texas Oncology - Gulf Coast
Pearland , Texas
Illinois CancerCare-Pekin
Pekin , Illinois
Illinois CancerCare, P.C.
Peoria , Illinois
Illinois CancerCare-Peru - Valley Regional Cancer Center
Peru , Illinois
Ironwood Cancer & Research Centers
Phoenix , Arizona
Florida Cancer Specialists
Port Charlotte , Florida
Hematology Oncology Associates of the Treasure Coast
БГ