Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07489066
PHASE2

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

Sponsor: Pfizer

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-06-30

Completion Date

2031-07-30

Last Updated

2026-10-08

Healthy Volunteers

No

Interventions

BIOLOGICAL

PF-08634404

Concentrate for solution for infusion

DRUG

Chemotherapy Regimen 1

Injection for intravenous use

DRUG

Chemotherapy Regimen 2

Injection for intravenous use

Locations (37)

Clearview Cancer Institute (Crestwood)

Huntsville, Alabama, United States

Clearview Cancer Institute

Huntsville, Alabama, United States

Stanford Cancer Institute

Stanford, California, United States

Stanford Hospital and Clinics

Stanford, California, United States

Stanford Hospital Investigational Drug Services

Stanford, California, 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

Nebraska Medicine- Bellevue Medical Center

Bellevue, Nebraska, United States

Cancer Partners of Nebraska

Lincoln, Nebraska, United States

Nebraska Medicine

Omaha, Nebraska, United States

Nebraska Medicine - Village Pointe

Omaha, Nebraska, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

New Mexico Oncology Hematology Consultants, Ltd

Albuquerque, New Mexico, United States

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Western Health-Sunshine & Footscray Hospitals

St Albans, Victoria, Australia

Beijing Cancer hospital

Beijing, Beijing Municipality, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

The Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Marien Hospital Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

LungenClinic Grosshansdorf

Großhansdorf, Germany

Prince of Wales Hospital

Hong Kong, Hong Kong

Sourasky Medical Center

Tel Aviv, TELL ABĪB, Israel

Casa di Cura Dott. Pederzoli

Peschiera del Garda, Verona, Italy

Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii

Wroclaw, Poland

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

Hospital Universitario Puerta de Hierro de Majadahonda

Majadahonda, Spain

Chung Shan Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan