Lung Cancer Clinical Trials

Find Lung Cancer Clinical Trials Near You

AN INTERVENTIONAL PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER

Status: Recruiting
Location: See all (153) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Arkansas
Highlands Oncology Group
RECRUITING
Fayetteville
Highlands Oncology Group
RECRUITING
Rogers
Highlands Oncology Group
RECRUITING
Springdale
Arizona
Ironwood Cancer & Research Centers
RECRUITING
Chandler
Ironwood Cancer & Research Centers
RECRUITING
Gilbert
Ironwood Cancer & Research Centers
RECRUITING
Glendale
Ironwood Cancer & Research Centers
RECRUITING
Goodyear
Ironwood Cancer & Research Centers
RECRUITING
Mesa
Ironwood Cancer & Research Centers
RECRUITING
Mesa
Ironwood Cancer & Research Centers
RECRUITING
Phoenix
Ironwood Cancer & Research Centers
RECRUITING
Scottsdale
California
Sansum Clinic
RECRUITING
Santa Barbara
Sansum Clinic
RECRUITING
Solvang
Florida
Florida Cancer Specialists
RECRUITING
Bonita Springs
Florida Cancer Specialists
RECRUITING
Bradenton
Florida Cancer Specialists
RECRUITING
Cape Coral
Florida Cancer Specialists
NOT_YET_RECRUITING
Clearwater
BRCR Global- Coral Springs
RECRUITING
Coral Springs
Florida Cancer Specialists
RECRUITING
Daytona Beach
Florida Cancer Specialists
RECRUITING
Fleming Island
Helios Clinical Research
RECRUITING
Fort Lauderdale
Florida Cancer Specialists
RECRUITING
Fort Myers
Florida Cancer Specialists
RECRUITING
Fort Myers
Florida Cancer Specialists - South
RECRUITING
Fort Myers
Florida Cancer Specialists
NOT_YET_RECRUITING
Gainesville
Florida Cancer Specialists
NOT_YET_RECRUITING
Largo
Florida Cancer Specialists
NOT_YET_RECRUITING
Lecanto
Florida Cancer Specialists
RECRUITING
N. Venice
Florida Cancer Specialists
RECRUITING
Naples
Florida Cancer Specialists
NOT_YET_RECRUITING
Ocala
Florida Cancer Specialists
NOT_YET_RECRUITING
Orange City
Mid Florida Hematology and Oncology Center
RECRUITING
Orange City
Florida Cancer Specialists
NOT_YET_RECRUITING
Orlando
Cancer Care Centers of Brevard, Inc.
RECRUITING
Palm Bay
Florida Cancer Specialists
RECRUITING
Palm Beach Gardens
Florida Cancer Specialists
RECRUITING
Port Charlotte
Hematology Oncology Associates of the Treasure Coast
NOT_YET_RECRUITING
Port Saint Lucie
Florida Cancer Specialists
RECRUITING
Sarasota
Florida Cancer Specialists
RECRUITING
Sebring
Florida Cancer Specialists
NOT_YET_RECRUITING
St. Petersburg
Florida Cancer Specialists
NOT_YET_RECRUITING
St. Petersburg
Florida Cancer Specialists
NOT_YET_RECRUITING
Tallahassee
BRCR Global - Tamarac
RECRUITING
Tamarac
Florida Cancer Specialists
NOT_YET_RECRUITING
Tampa
Florida Cancer Specialists
NOT_YET_RECRUITING
Tavares
Florida Cancer Specialists
NOT_YET_RECRUITING
The Villages
Florida Cancer Specialists
NOT_YET_RECRUITING
Trinity
Florida Cancer Specialists
RECRUITING
Wellington
Florida Cancer Specialists - East
RECRUITING
West Palm Beach
Florida Cancer Specialists
NOT_YET_RECRUITING
Winter Park
Illinois
Illinois Cancer Specialists
RECRUITING
Arlington Heights
Illinois CancerCare - Bloomington
RECRUITING
Bloomington
Illinois CancerCare - Galesburg
RECRUITING
Galesburg
Hope and Healing Cancer Services
RECRUITING
Hinsdale
Hope and Healing Cancer Services
RECRUITING
New Lenox
Illinois CancerCare-Ottawa-Fox River Cancer Center
RECRUITING
Ottawa
Illinois CancerCare-Pekin
RECRUITING
Pekin
Illinois CancerCare, P.C.
RECRUITING
Peoria
Illinois CancerCare-Peru - Valley Regional Cancer Center
RECRUITING
Peru
Illinois CancerCare-Washington
RECRUITING
Washington
Maryland
Maryland Oncology Hematology, P.A.
RECRUITING
Annapolis
Maryland Oncology Hematology, P.A.
RECRUITING
Bethesda
Maryland Oncology Hematology, P.A.
RECRUITING
Brandywine
Maryland Oncology Hematology - Columbia
RECRUITING
Columbia
Maryland Oncology Hematology, P.A.
RECRUITING
Germantown
Maryland Oncology Hematology, P.A.
RECRUITING
Largo
Maryland Oncology Hematology, P.A.
RECRUITING
Rockville
Maryland Oncology Hematology, P.A.
RECRUITING
Silver Spring
Minnesota
Minnesota Oncology Hematology, P.A.
RECRUITING
Burnsville
Minnesota Oncology Hematology, P.A.
RECRUITING
Chaska
Minnesota Oncology Hematology, P.A.
RECRUITING
Coon Rapids
Minnesota Oncology Hematology, P.A.
RECRUITING
Edina
Minnesota Oncology Hematology, P.A.
RECRUITING
Maple Grove
Minnesota Oncology Hematology, P.A.
RECRUITING
Maplewood
Minnesota Oncology Hematology, P.A.
RECRUITING
Woodbury
North Carolina
Carolina Cancer Research Center
NOT_YET_RECRUITING
Wilson
Nebraska
Cancer Partners of Nebraska - April Sampson Cancer Center
RECRUITING
Lincoln
Nebraska Hematology-Oncology, P.C.
NOT_YET_RECRUITING
Lincoln
New York
Hematology Oncology Associates of Rockland
RECRUITING
Nyack
Oregon
Northwest Cancer Specialists, P.C.
RECRUITING
Portland
Northwest Cancer Specialists, P.C.
RECRUITING
Portland
Northwest Cancer Specialists, P.C.
RECRUITING
Tigard
Tennessee
Tennessee Cancer Specialists Dowell Springs location
RECRUITING
Knoxville
SCRI Oncology Partners
RECRUITING
Nashville
Texas
Texas Oncology - West Texas
RECRUITING
Abilene
Texas Oncology - Northeast Texas
RECRUITING
Allen
Texas Oncology - West Texas
RECRUITING
Amarillo
Texas Oncology - Central/South Texas
RECRUITING
Austin
Texas Oncology - Gulf Coast
RECRUITING
Beaumont
Texas Oncology - Northeast Texas
RECRUITING
Denison
Texas Oncology - Northeast Texas
RECRUITING
Denton
Texas Oncology - West Texas
RECRUITING
El Paso
Texas Oncology - West Texas
RECRUITING
El Paso
Texas Oncology - West Texas
RECRUITING
El Paso
Texas Oncology - Northeast Texas
RECRUITING
Flower Mound
Texas Oncology - Central/South Texas
RECRUITING
Harlingen
Texas Oncology - Gulf Coast
RECRUITING
Houston
Texas Oncology - Gulf Coast
RECRUITING
Houston
Texas Oncology - Gulf Coast
RECRUITING
Houston
Texas Oncology - Gulf Coast
RECRUITING
Humble
US Oncology Investigational Products Center
RECRUITING
Irving
US Oncology Investigational Products Center (IPC)
RECRUITING
Irving
Texas Oncology - Northeast Texas
RECRUITING
Lewisville
Texas Oncology - Northeast Texas
RECRUITING
Longview
Texas Oncology - Central/South Texas
RECRUITING
Mcallen
Texas Oncology - Northeast Texas
RECRUITING
Mckinney
Texas Oncology - West Texas
RECRUITING
Midland
Texas Oncology - West Texas
RECRUITING
Odessa
Texas Oncology - Northeast Texas
RECRUITING
Palestine
Texas Oncology - Northeast Texas
RECRUITING
Paris
Texas Oncology - Gulf Coast
RECRUITING
Pearland
Texas Oncology - Gulf Coast
RECRUITING
Sugar Land
Texas Oncology - Gulf Coast
RECRUITING
The Woodlands
Texas Oncology - Northeast Texas
RECRUITING
Tyler
Texas Oncology - Central/South Texas
RECRUITING
Waco
Texas Oncology - Gulf Coast
RECRUITING
Webster
Texas Oncology - Central/South Texas
RECRUITING
Weslaco
Texas Oncology - West Texas
RECRUITING
Wichita Falls
Washington
Northwest Cancer Specialists - Vancouver
RECRUITING
Vancouver
Wisconsin
Minnesota Oncology Hematology, P.A.
RECRUITING
Hudson
Other Locations
Argentina
Instituto Argentino de Diagnóstico y Tratamiento (IADT)
NOT_YET_RECRUITING
Ciudad Autónoma De Buenos Aires
Australia
Sunshine Coast University Hospital
RECRUITING
Birtinya
Gympie Hospital
RECRUITING
Gympie
Icon Cancer Centre Hobart
RECRUITING
Hobart
Nambour General Hospital
RECRUITING
Nambour
Israel
Hadassah Medical Center
RECRUITING
Jerusalem
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Sourasky Medical Center
RECRUITING
Tel Aviv
Yitzhak Shamir Medical Center
NOT_YET_RECRUITING
Ẕerifin
Japan
National Hospital Organization Beppu Medical Center
NOT_YET_RECRUITING
Beppu
National Hospital Organization Kyushu Cancer Center
RECRUITING
Fukuoka
Kansai Medical University Hospital
RECRUITING
Hirakata-shi
National Hospital Organization Kanazawa Medical Center
NOT_YET_RECRUITING
Kanazawa
National Hospital Organization Tokyo National Hospital
NOT_YET_RECRUITING
Kiyose
Kobe City Medical Center General Hospital
NOT_YET_RECRUITING
Kobe
Kobe Minimally Invasive Cancer Center
RECRUITING
Kobe
National Hospital Organization Kochi National Hospital
RECRUITING
Kochi
National Hospital Organization Kyoto Medical Center
RECRUITING
Kyoto
National Hospital Organization Shikoku Cancer Center
NOT_YET_RECRUITING
Matsuyama
National Hospital Organization Okayama Medical Center
RECRUITING
Okayama
National Hospital Organization Nagasaki Medical Center
RECRUITING
Ōmura
Gunma Prefectural Cancer Center
NOT_YET_RECRUITING
Otashi
Hokkaido University Hospital
RECRUITING
Sapporo
The University of Osaka Hospital
RECRUITING
Suita
Mie Chuo Medical Center
RECRUITING
Tsu
National Hospital Organization Yamaguchi Ube Medical Center
NOT_YET_RECRUITING
Ube
Puerto Rico
Pan American Center for Oncology Trials, LLC- Dorado Office
RECRUITING
Dorado
Pan American Center for Oncology Trials, LLC
RECRUITING
Rio Piedras
BRCR Global Puerto Rico - Hato Rey
RECRUITING
San Juan
Taiwan
Changhua Christian Hospital
NOT_YET_RECRUITING
Changhua County
Chung Shan Medical University Hospital
NOT_YET_RECRUITING
Taichung
Taipei Medical University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
NOT_YET_RECRUITING
Taipei
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2026-01-06
Estimated Completion Date: 2032-08-26
Participants
Target number of participants: 1410
Treatments
Experimental: Arm A
Participants will receive PF-08634404 combined with chemotherapy regimen 1, followed by maintenance therapy with PF-08634404.
Active_comparator: Arm B
Participants will receive pembrolizumab combined with chemotherapy regimen 1, followed by maintenance therapy with pembrolizumab.
Experimental: Arm C
Participants will receive PF-08634404 combined with chemotherapy regimen 2, followed by maintenance therapy with PF-08634404 and chemotherapy.
Active_comparator: Arm D
Participants will receive pembrolizumab combined with chemotherapy regimen 2, followed by maintenance therapy with pembrolizumab and chemotherapy.
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov

Similar Clinical Trials