RecruitingPhase 2NCT07489066

Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone or in Combination in Early-stage or Locally Advanced NSCLC

AN INTERVENTIONAL, OPEN-LABEL, PHASE 2 STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY OR IN COMBINATION IN ADULT PARTICIPANTS WITH EARLY-STAGE RESECTABLE OR LOCALLY ADVANCED UNRESECTABLE NON-SMALL CELL LUNG CANCER


Sponsor

Pfizer

Enrollment

120 participants

Start Date

Jun 30, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Chemotherapy Regimen 1, a drug called Chemotherapy Regimen 2, and others for people with carcinoma, carcinoma, non-small-cell lung (nsclc), and other related conditions. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPF-08634404

Concentrate for solution for infusion

DRUGChemotherapy Regimen 1

Injection for intravenous use

DRUGChemotherapy Regimen 2

Injection for intravenous use


Locations(14)

Clearview Cancer Institute (Crestwood)

Huntsville, Alabama, United States

Clearview Cancer Institute

Huntsville, Alabama, United States

University Cancer & Blood Center, LLC

Athens, Georgia, United States

Hope and Healing Clinical Research

Hinsdale, Illinois, United States

Hope and Healing Clinical Research

New Lenox, Illinois, United States

Cancer Partners of Nebraska

Lincoln, Nebraska, United States

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Pan American Center for Oncology Trials, LLC - Bayamón Office

Bayamón, Puerto Rico

Pan American Center for Oncology Trials, LLC - Manati Office

Manati, Puerto Rico

Pan American Center for Oncology Trials, LLC - Ponce Office

Ponce, Puerto Rico

Hospital Oncologico Dr. Isaac Gonzalez Martinez

Rio Piedras, Puerto Rico

Pan American Center for Oncology Trials, LLC - Ciudadela Office

San Juan, Puerto Rico

Taipei Medical University Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT07489066


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