New lung cancer drug shows promise in early trial
NCT ID NCT07489066
First seen Jun 24, 2026 · Last updated Sep 15, 2026 · Updated 7 times
Summary
This study tests a new medicine called PF-08634404, given alone or with chemotherapy, for adults with early or locally advanced non-small cell lung cancer. The trial has three parts: before surgery, after surgery if cancer remains, or after chemoradiation. Researchers will check safety and how well the drug shrinks or controls the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PF-08634404 (also known as SSGJ-707), a biologic drug given by infusion, sometimes with chemotherapy
- What this could lead to
- If successful, this could offer a new treatment option for non-small cell lung cancer, potentially shrinking tumors before surgery or controlling cancer after standard therapy.
- What could go wrong
- This is an early Phase 2 study with only 120 participants, so results may not apply to everyone. The drug may cause side effects or not work better than existing treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jul 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
27 sites in 7 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Cancer hospital
RECRUITINGBeijing, Beijing Municipality, 100142, China
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Cancer Partners of Nebraska
RECRUITINGLincoln, Nebraska, 68516, United States
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Chung Shan Medical University Hospital
RECRUITINGTaichung, 40201, Taiwan
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Clearview Cancer Institute
RECRUITINGHuntsville, Alabama, 35805, United States
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Clearview Cancer Institute (Crestwood)
RECRUITINGHuntsville, Alabama, 35801, United States
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Guangdong Provincial People's Hospital
RECRUITINGGuangzhou, Guangdong, 510180, China
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Hope and Healing Clinical Research
RECRUITINGHinsdale, Illinois, 60521, United States
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Hope and Healing Clinical Research
RECRUITINGNew Lenox, Illinois, 60451, United States
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Hospital Oncologico Dr. Isaac Gonzalez Martinez
RECRUITINGRio Piedras, 00935, Puerto Rico
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National Cheng Kung University Hospital
RECRUITINGTainan, 704, Taiwan
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National Taiwan University Hospital
NOT_YET_RECRUITINGTaipei, 100, Taiwan
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New Mexico Oncology Hematology Consultants, Ltd
NOT_YET_RECRUITINGAlbuquerque, New Mexico, 87109, United States
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Pan American Center for Oncology Trials, LLC - Bayamón Office
RECRUITINGBayamón, 00959, Puerto Rico
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Pan American Center for Oncology Trials, LLC - Ciudadela Office
RECRUITINGSan Juan, 00909, Puerto Rico
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Pan American Center for Oncology Trials, LLC - Manati Office
RECRUITINGManati, 00674, Puerto Rico
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Pan American Center for Oncology Trials, LLC - Ponce Office
RECRUITINGPonce, 00730, Puerto Rico
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Prince of Wales Hospital
NOT_YET_RECRUITINGHong Kong, Hong Kong
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Sourasky Medical Center
NOT_YET_RECRUITINGTel Aviv, TELL ABĪB, 6423906, Israel
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Stanford Cancer Institute
RECRUITINGStanford, California, 94305, United States
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Stanford Hospital Investigational Drug Services
RECRUITINGStanford, California, 94305, United States
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Stanford Hospital and Clinics
RECRUITINGStanford, California, 94305, United States
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Taipei Medical University Hospital
RECRUITINGTaipei, 110, Taiwan
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Taipei Veterans General Hospital
RECRUITINGTaipei, 11217, Taiwan
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The Affiliated Cancer Hospital of Shandong First Medical University
RECRUITINGJinan, Shandong, 250117, China
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University Cancer & Blood Center, LLC
RECRUITINGAthens, Georgia, 30607, United States
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University of Tennessee Medical Center
RECRUITINGKnoxville, Tennessee, 37920, United States
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Western Health-Sunshine & Footscray Hospitals
RECRUITINGSt Albans, Victoria, 3021, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Smaller chest drain may speed recovery after lung cancer surgery
- Gut bacteria may hold clues to why some cancer treatments work better
- Breath-Tracking sensor aims to sharpen lung cancer scans
- Can PET scan signals predict who beats lung cancer with immunotherapy?
- Which nerve block wins for lung surgery pain?