Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone or in Combination in Early-stage or Locally Advanced NSCLC
Start Date
6/30/2026
Completion Date
7/30/2031
Summary
This study is being done to learn more about a new medicine called PF-08634404. The study team wants to understand how well it works when given alone or with chemotherapy. The study is for adults with early stage or locally advanced non-small cell lung cancer (NSCLC) that may or may not be removable with surgery. The study is seeking participants who: * Are aged 18 years or older * Have either: * Early-stage or locally advanced (Stage II or IIIA/B) NSCLC and are a candidate for neoadjuvant therapy, followed by surgical removal of the tumor. Neoadjuvant therapy is a treatment given as a first step to shrink the tumor before surgery. * Early-stage or locally advanced (Stage II or IIIA/B) NSCLC and are a candidate for adjuvant therapy and did not achieve a pathological complete response (pCR) from approved treatment that was administered before surgery. Adjuvant therapy is an additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. pCR is defined as absence of viable tumor in all surgically removed samples. * Locally advanced (Stage III) NSCLC that may not be removable with surgery, was treated with concurrent chemoradiotherapy (cCRT), and is a candidate for additional treatment, otherwise known as consolidation therapy. cCRT is chemotherapy and radiation given simultaneously. * Be in good physical condition and have healthy organs based on medical tests. * Do not have known actionable changes in DNA The study has 3 parts and each participant will be assigned to one part by their doctor based on their disease diagnosis: * Part A will test PF-08634404 given with chemotherapy in the neoadjuvant setting, followed by surgery. * Part B will test PF-08634404 alone in adults who already were treated with neoadjuvant chemo-immunotherapy, underwent surgery, and did not achieve pCR per tumor tissue pathology analysis. Neoadjuvant chemo-immunotherapy refers to the combination of chemotherapy with immunotherapy per local standard-of-care, given before surgical removal of the tumor. * Part C will test PF-08634404 alone in adults with unresectable disease who received cCRT and did not have progressive disease. Progressive disease refers to a condition that grows, spreads, or worsens. All treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
PF-08634404
Chemotherapy Regimen 1
Chemotherapy Regimen 2
Conditions
Locations
Clearview Cancer Institute (Crestwood)
Huntsville, Alabama 35801
United States
Clearview Cancer Institute
Huntsville, Alabama 35805
United States
University Cancer & Blood Center, LLC
Athens, Georgia 30607
United States
Hope and Healing Clinical Research
Hinsdale, Illinois 60521
United States
Hope and Healing Clinical Research
New Lenox, Illinois 60451
United States
Cancer Partners of Nebraska
Lincoln, Nebraska 68516
United States
University of Tennessee Medical Center
Knoxville, Tennessee 37920
United States
Guangdong Provincial People's Hospital
Guangzhou, Guangdong 510180
China
Pan American Center for Oncology Trials, LLC - Bayamón Office
Bayamón, 00959
Puerto Rico
Pan American Center for Oncology Trials, LLC - Manati Office
Manati, 00674
Puerto Rico
Pan American Center for Oncology Trials, LLC - Ponce Office
Ponce, 00730
Puerto Rico
Hospital Oncologico Dr. Isaac Gonzalez Martinez
Rio Piedras, 00935
Puerto Rico
Pan American Center for Oncology Trials, LLC - Ciudadela Office
San Juan, 00909
Puerto Rico
Taipei Medical University Hospital
Taipei, 110
Taiwan