Recruiting
Phase 2

PF-08634404

Sponsor:

Pfizer

Code:

NCT07489066

Conditions

Carcinoma

Non-Small-Cell Lung

Lung Cancer (NSCLC)

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung (NSCLC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PF-08634404

Chemotherapy Regimen 1

Chemotherapy Regimen 2

Study Details

Brief 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.

Conditions

Carcinoma

Non-Small-Cell Lung

Lung Cancer (NSCLC)

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung (NSCLC)

Study ID

NCT07489066

Start date

Jun 30, 2026

Status verified date

Aug, 2026

Completion date

Jul 30, 2031

Anticipated

Primary completion date

Jul 29, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A: Neoadjuvant PF-08634404 + Chemotherapy

Participants with treatment naïve early-stage or locally advanced, resectable NSCLC without Actionable Genomic Alterations (AGAs) who are candidates for neoadjuvant treatment will receive intravenous (IV) PF-08634404 in combination with chemotherapy.

experimental: Part B: Adjuvant PF-08634404 Monotherapy

Participants with early-stage or locally advanced, resectable NSCLC without AGAs who did not achieve pCR after standard-of-care (SOC) neoadjuvant chemo-immunotherapy and are candidates for adjuvant treatment will receive PF-08634404 IV.

experimental: Part C: PF-08634404 Monotherapy Consolidation after Definitive Chemoradiotherapy

Participants with locally advanced, unresectable NSCLC without AGAs who did not have progressive disease per RECIST 1.1 after definitive, platinum-based concurrent chemoradiotherapy (cCRT) and are candidates for consolidation treatment will receive PF-08634404 IV.

Interventions

PF-08634404

Concentrate for solution for infusion

Chemotherapy Regimen 1

Injection for intravenous use

Chemotherapy Regimen 2

Injection for intravenous use

Primary outcome measure

  • Number of Participants With Adverse Events (AEs) [ Time Frame: Through 90 days after the last dose of study intervention (Part A only: or 90 days after surgery, whichever is later) ]
  • Part A: Surgical Feasibility Rate [ Time Frame: Up to approximately 6 months after first dose ]
  • Part A: Pathological Complete Response (pCR) rate per International Association for the Study of Lung Cancer (IASLC) guidelines as assessed by central pathology review [ Time Frame: Up to approximately 6 months after first dose ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Clearview Cancer Institute (Crestwood)

Recruiting

Huntsville, Alabama, United States, 35801

Clearview Cancer Institute

Recruiting

Huntsville, Alabama, United States, 35805

University Cancer & Blood Center, LLC

Recruiting

Athens, Georgia, United States, 30607

Hope and Healing Clinical Research

Recruiting

Hinsdale, Illinois, United States, 60521

Hope and Healing Clinical Research

Recruiting

New Lenox, Illinois, United States, 60451

Cancer Partners of Nebraska

Recruiting

Lincoln, Nebraska, United States, 68516

University of Tennessee Medical Center

Recruiting

Knoxville, Tennessee, United States, 37920

More Information

Sponsor

Pfizer

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • early stage non small cell lung cancer
  • NSCLC
  • adjuvant NSCLC
  • locally advanced non small cell lung cancer
  • resectable NSCLC
  • unresectable NSCLC
  • neoadjuvant NSCLC
  • consolidation NSCLC
  • squamous NSCLC
  • non-squamous NSCLC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Pfizer on 2026-08-17.