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
Purpose
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.
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
- Masking Description
- This is double-blind study, neither the participants nor the study team will know whether the participants are receiving PF-08634404 or Pembrolizumab.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Bullhead City, Arizona 86442
Chandler, Arizona 85224
Gilbert, Arizona 85297
Glendale, Arizona 85306
Goodyear, Arizona 85395
Mesa, Arizona 85202
Mesa, Arizona 85206
Phoenix, Arizona 85028
Scottsdale, Arizona 85260
Fayetteville, Arkansas 72703
Rogers, Arkansas 72758
Springdale, Arkansas 72762
Anaheim, California 92805
Fountain Valley, California 92708
Fountain Valley, California 92708
Fountain Valley, California 92708
Fountain Valley, California 92708
Glendale, California 91204
Laguna Hills, California 92653
Lodi, California 95242
Long Beach, California 90806
Los Angeles, California 90017
Manteca, California 95336
Modesto, California 95350
Riverside, California 92501
Santa Barbara, California 93105
Solvang, California 93463
Stockton, California 95204
Tracy, California 95377
Van Nuys, California 91405
Bonita Springs, Florida 34135
Bradenton, Florida 34211
Cape Coral, Florida 33909
Clearwater, Florida 33761
Coral Springs, Florida 33065
Daytona Beach, Florida 32117
Fleming Island, Florida 32003
Fleming Island, Florida 32003
Fort Lauderdale, Florida 33316
Fort Myers, Florida 33901
Fort Myers, Florida 33905
Fort Myers, Florida 33908
Gainesville, Florida 32605
Jacksonville, Florida 32204
Jacksonville, Florida 32218
Jacksonville, Florida 32256
Jacksonville, Florida 32258
Largo, Florida 33770
Lecanto, Florida 34461
N. Venice, Florida 34275
Naples, Florida 34102
Neptune Beach, Florida 32266
Ocala, Florida 34474
Orange City, Florida 32763
Orange City, Florida 32763
Orange City, Florida 32763
Orlando, Florida 32806
Orlando, Florida 32806
Orlando, Florida 32806
Orlando, Florida 32806
Palm Bay, Florida 32901
Palm Beach Gardens, Florida 33410
Port Charlotte, Florida 33980
Port Saint Lucie, Florida 34952
Saint Augustine, Florida 32086
Sarasota, Florida 34236
Sebring, Florida 33870
St. Petersburg, Florida 33701
St. Petersburg, Florida 33705
Tallahassee, Florida 32308
Tamarac, Florida 33321
Tampa, Florida 33607
Tavares, Florida 32778
The Villages, Florida 32159
Trinity, Florida 34655
Wellington, Florida 33414
West Palm Beach, Florida 33401
Winter Park, Florida 32789
Arlington Heights, Illinois 60005
Bloomington, Illinois 61704
Chicago, Illinois 60612
Chicago, Illinois 60612
Galesburg, Illinois 61401
Hinsdale, Illinois 60521
New Lenox, Illinois 60451
Ottawa, Illinois 61350
Pekin, Illinois 61554
Peoria, Illinois 61615
Peru, Illinois 61354
Washington, Illinois 61571
Covington, Louisiana 70433
Hammond, Louisiana 70403
Annapolis, Maryland 21401
Bethesda, Maryland 20817
Brandywine, Maryland 20613
Columbia, Maryland 21044
Germantown, Maryland 20876
Largo, Maryland 20774
Rockville, Maryland 20850
Silver Spring, Maryland 20904
Burnsville, Minnesota 55337
Chaska, Minnesota 55318
Coon Rapids, Minnesota 55433
Edina, Minnesota 55435
Maple Grove, Minnesota 55369
Maplewood, Minnesota 55109
Woodbury, Minnesota 55125
Hattiesburg, Mississippi 39401
Lincoln, Nebraska 68506
Lincoln, Nebraska 68506
Lincoln, Nebraska 68516
Albany, New York 12206
Clifton Park, New York 12065
Nyack, New York 10960
Pinehurst, North Carolina 28374
Pinehurst, North Carolina 28374
Wilson, North Carolina 27893
Cincinnati, Ohio 45211
Cincinnati, Ohio 45242
Cincinnati, Ohio 45245
Cleveland, Ohio 44106
Fairfield, Ohio 45014
Happy Valley, Oregon 97015
Portland, Oregon 97227
Tigard, Oregon 97223
Chattanooga, Tennessee 37403
Chattanooga, Tennessee 37404
Franklin, Tennessee 37067
Gallatin, Tennessee 37066
Knoxville, Tennessee 37909
Knoxville, Tennessee 37920
Knoxville, Tennessee 37932
Lebanon, Tennessee 37090
Mount Juliet, Tennessee 37122
Murfreesboro, Tennessee 37129
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Nashville, Tennessee 37205
Shelbyville, Tennessee 37160
Abilene, Texas 79606
Allen, Texas 75013
Amarillo, Texas 79124
Arlington, Texas 76012
Arlington, Texas 76014
Austin, Texas 78758
Beaumont, Texas 77702
Bedford, Texas 76022
Dallas, Texas 75203
Dallas, Texas 75230
Dallas, Texas 75231
Dallas, Texas 75237
Dallas, Texas 75246
Denison, Texas 75020
Denton, Texas 76201
El Paso, Texas 79902
El Paso, Texas 79915
El Paso, Texas 79938
Flower Mound, Texas 75028
Fort Worth, Texas 76104
Grapevine, Texas 76051
Harlingen, Texas 78550
Houston, Texas 77024
Houston, Texas 77054
Houston, Texas 77070
Humble, Texas 77338
Irving, Texas 75063
Irving, Texas 75063
Lewisville, Texas 75056
Longview, Texas 75601
McAllen, Texas 78503
McKinney, Texas 75071
Midland, Texas 79701
Odessa, Texas 79761
Palestine, Texas 75801
Paris, Texas 75460
Pearland, Texas 77584
Plano, Texas 75075
Plano, Texas 75093
Sugar Land, Texas 77479
The Woodlands, Texas 77380
Tyler, Texas 75702
Waco, Texas 76712
Webster, Texas 77598
Weslaco, Texas 78596
Wichita Falls, Texas 76310
Salt Lake City, Utah 84112
Charlottesville, Virginia 22903
Charlottesville, Virginia 22903
Charlottesville, Virginia 22908
Charlottesville, Virginia 22911
Vancouver, Washington 98684
Hudson, Wisconsin 54016
Dorado, Puerto Rico 00646
Manati, Puerto Rico 00674
Mayagüez, Puerto Rico 00680
San Juan, Puerto Rico 00917
More Details
- Status
- Recruiting
- Sponsor
- Pfizer