NCT07489066
Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone or in Combination in Early-stage or Locally Advanced NSCLC
Recruiting
PHASE2Ages 18+InterventionalTreatmentPfizer
~120 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:PF-08634404Chemotherapy Regimen 1Chemotherapy Regimen 2
At a glance
Recruiting sites
10 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With Adverse Events (AEs)
Measured over Through 90 days after the last dose of study intervention (Part A only: or 90 days after surgery, whichever is later)
+2 more outcomes measured
Conditions
Where it's being run
14 sites across 8 statesPuerto Rico5
Alabama2
Illinois2
Georgia1
Nebraska1
Tennessee1
Guangdong1
Taiwan1
Study leadership
- Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
18 years of age or older at screening.
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
Adequate organ function
Eastern Cooperative Oncology Group performance status (ECOG) score of 0 or 1
Part A only: Participants must have newly diagnosed, previously untreated, pathologically confirmed early-stage or LA (Stage II or IIIA/B), squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) with disease that is considered resectable, as assessed by a multidisciplinary evaluation, which must include a thoracic surgeon who performs lung cancer surgery as a prominent part of his/her practice. The participant must be a candidate for neoadjuvant therapy followed by complete surgical resection.
Part B only: Participants must have pathologically confirmed early-stage or LA (Stage II or IIIA/B), squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) and have undergone complete surgical resection. The participant must be considered a candidate for adjuvant therapy and must not have achieved pCR with SOC neoadjuvant chemo-immunotherapy.
Part C only: Participants must have pathologically confirmed LA, unresectable (Stage III) squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) and have received ≥ 60 Gy of radiation and ≥ 2 cycles of definitive, platinum-based concurrent chemotherapy and achieved SD or better per RECIST 1.1.
Exclusion
Participants with known EGFR and ALK AGAs; documented negative results for EGFR and ALK AGAs are required for participants with non-squamous histology.
Participants with CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression.
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.
Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.
What this trial measures
- Number of Participants With Adverse Events (AEs)Through 90 days after the last dose of study intervention (Part A only: or 90 days after surgery, whichever is later)
AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s).
- Part A: Surgical Feasibility RateUp to approximately 6 months after first dose
Surgical Feasibility rate is defined by the proportion of participants undergoing surgery and the proportion of participants with wound complications after surgery.
- Part A: Pathological Complete Response (pCR) rate per International Association for the Study of Lung Cancer (IASLC) guidelines as assessed by central pathology reviewUp to approximately 6 months after first dose
pCR rate by central pathology review is defined as the proportion of participants having pCR as assessed by central pathologist. pCR is defined as the absence of residual tumor in surgical specimens