Actively Recruiting
Study of PF-08634404 Alone or with Chemotherapy in Early-Stage or Locally Advanced Non-Small Cell Lung Cancer
Led by Pfizer · Updated on 2026-06-08
120
Participants Needed
3
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new medicine called PF-08634404 in adults with early-stage or locally advanced non-small cell lung cancer (NSCLC). The study aims to understand how well this medicine works alone or combined with chemotherapy in patients whose tumors may or may not be removable by surgery. This is a phase 2, open-label trial focusing on different treatment strategies based on disease stage and prior therapies. The study has three parts. Part A tests PF-08634404 combined with chemotherapy before surgery (neoadjuvant therapy) in patients with resectable NSCLC. Part B gives PF-08634404 alone after surgery to patients who did not have a complete response to prior chemo-immunotherapy. Part C evaluates PF-08634404 alone as consolidation treatment in patients with locally advanced, unresectable NSCLC who previously received chemoradiotherapy without disease progression. Treatments are administered intravenously at clinical sites. Participants will be monitored closely with medical tests and evaluations throughout the study. Researchers will assess safety by tracking adverse events and laboratory results up to 90 days after treatment or surgery. They will also measure response to treatment using tumor tissue pathology, imaging, and survival outcomes over up to five years. The study includes continuous follow-up to evaluate disease status and overall survival.
CONDITIONS
Brief Title
Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone or in Combination in Early-stage or Locally Advanced NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at screening
- Tumor tissue available from biopsy or surgery
- PD-L1 status available from local testing
- Adequate organ function
- ECOG performance status of 0 or 1
- Part A: Newly diagnosed, untreated early-stage or locally advanced resectable NSCLC, candidate for neoadjuvant therapy and surgery
- Part B: Early-stage or locally advanced NSCLC with complete surgical resection, candidate for adjuvant therapy, and no complete pathological response after prior chemo-immunotherapy
- Part C: Locally advanced unresectable NSCLC, treated with chemoradiotherapy, with stable disease or better
You will not qualify if you...
- Known actionable EGFR or ALK genomic alterations
- CNS lesions including brain or spinal metastases or compression
- Significant risk of bleeding or fistula
- History of another cancer within 3 years or residual disease from prior cancer
- Unresolved toxicities from prior anti-tumor therapy
- Severe allergy to study treatment components or chimeric/humanized antibodies
- History of organ or stem cell transplantation
- Evidence of interstitial lung disease or severe pulmonary disease unrelated to cancer
- Uncontrolled cardiac, cerebrovascular, or other major conditions within 6 months
- Recent major or minor surgery before study treatment
- History of severe bleeding or coagulation problems
- Recent serious gastrointestinal conditions within 6 months
- Active infections including HIV, hepatitis B or C
- History of immunodeficiency
- Medical or psychiatric conditions increasing study risk, including recent suicidal behavior
- Breastfeeding or unwillingness to follow contraceptive measures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 6 months after first dose
Participants receive PF-08634404 alone or in combination with chemotherapy depending on their disease stage and prior treatments.
Multiple visits for treatment administration and assessments during therapy
Duration - Up to approximately 5 years
Participants are monitored for safety, disease progression, and survival after treatment ends.
Periodic visits for outcome assessments and safety monitoring
Trial Site Locations
Total: 3 locations
1
Hope and Healing Clinical Research
Hinsdale, Illinois, United States, 60521
Actively Recruiting
2
Hope and Healing Clinical Research
New Lenox, Illinois, United States, 60451
Actively Recruiting
3
Pan American Center for Oncology Trials, LLC - Manati Office
Manati, Puerto Rico, 00674
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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