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New lung cancer drug shows promise in early trial

NCT ID NCT07489066

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jul 2031

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    27 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Beijing Cancer hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Cancer Partners of Nebraska

    RECRUITING

    Lincoln, Nebraska, 68516, United States

  • Chung Shan Medical University Hospital

    RECRUITING

    Taichung, 40201, Taiwan

  • Clearview Cancer Institute

    RECRUITING

    Huntsville, Alabama, 35805, United States

  • Clearview Cancer Institute (Crestwood)

    RECRUITING

    Huntsville, Alabama, 35801, United States

  • Guangdong Provincial People's Hospital

    RECRUITING

    Guangzhou, Guangdong, 510180, China

  • Hope and Healing Clinical Research

    RECRUITING

    Hinsdale, Illinois, 60521, United States

  • Hope and Healing Clinical Research

    RECRUITING

    New Lenox, Illinois, 60451, United States

  • Hospital Oncologico Dr. Isaac Gonzalez Martinez

    RECRUITING

    Rio Piedras, 00935, Puerto Rico

  • National Cheng Kung University Hospital

    RECRUITING

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    NOT_YET_RECRUITING

    Taipei, 100, Taiwan

  • New Mexico Oncology Hematology Consultants, Ltd

    NOT_YET_RECRUITING

    Albuquerque, New Mexico, 87109, United States

  • Pan American Center for Oncology Trials, LLC - Bayamón Office

    RECRUITING

    Bayamón, 00959, Puerto Rico

  • Pan American Center for Oncology Trials, LLC - Ciudadela Office

    RECRUITING

    San Juan, 00909, Puerto Rico

  • Pan American Center for Oncology Trials, LLC - Manati Office

    RECRUITING

    Manati, 00674, Puerto Rico

  • Pan American Center for Oncology Trials, LLC - Ponce Office

    RECRUITING

    Ponce, 00730, Puerto Rico

  • Prince of Wales Hospital

    NOT_YET_RECRUITING

    Hong Kong, Hong Kong

  • Sourasky Medical Center

    NOT_YET_RECRUITING

    Tel Aviv, TELL ABĪB, 6423906, Israel

  • Stanford Cancer Institute

    RECRUITING

    Stanford, California, 94305, United States

  • Stanford Hospital Investigational Drug Services

    RECRUITING

    Stanford, California, 94305, United States

  • Stanford Hospital and Clinics

    RECRUITING

    Stanford, California, 94305, United States

  • Taipei Medical University Hospital

    RECRUITING

    Taipei, 110, Taiwan

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 11217, Taiwan

  • The Affiliated Cancer Hospital of Shandong First Medical University

    RECRUITING

    Jinan, Shandong, 250117, China

  • University Cancer & Blood Center, LLC

    RECRUITING

    Athens, Georgia, 30607, United States

  • University of Tennessee Medical Center

    RECRUITING

    Knoxville, Tennessee, 37920, United States

  • Western Health-Sunshine & Footscray Hospitals

    RECRUITING

    St Albans, Victoria, 3021, Australia

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