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New drug combo aims to shrink lung tumors before surgery

NCT ID NCT06123754

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding the immunotherapy drug envafolimab to standard chemotherapy helps shrink tumors before surgery and delays cancer return in people with stage III non-small cell lung cancer. About 390 participants will receive either envafolimab plus chemo or a placebo plus chemo, followed by surgery and more treatment. The main goals are to see how many tumors have few remaining cancer cells after treatment and how long people live without the cancer getting worse.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 390 people

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

Started

Nov 2023

Expected to finish

Dec 2027

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: 1. Volunteer to participate and sign the informed consent form. 2. Age ≥ 18 years old, regardless of gender. 3. Histological and/or cytological diagnosis of resectable stage IIIA-IIIB (N2) NSCLC. 4. Measurable lesions based on the response evaluation criteria in solid tumors version 1.1(RECIST 1.1). 5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 6. Subjects should provide tumor tissue for detection of PD-L1 expression level. 7. Sufficient organ and bone marrow function. 8. Expected survival ≥6 months. 9. The surgeon assessed that total lung function is able to withstand the proposed pneumonectomy procedure. Exclusion Criteria: 1. Tumor histologically or cytologically confirmed or combined with neuroendocrine carcinoma components, or sarcomatous/sarcomatoid lesions, or adenosquamous carcinoma, or special pathological types. 2. Previous treatment with another drug that targets T cell receptors (e.g. CTLA-4, OX-40, etc.); 3. Participants with known EGFR mutation or ALK translocation, and non-squamous cell carcinoma subjects need to identify EGFR and ALK mutation status; 4. Upper lung sulcus tumor or locally advanced unresectable or metastatic disease. 5. Previous anti-tumor therapy for the disease. 6. Subjects with known or suspected interstitial pneumonia.Radiation pneumonia or other moderate to severe lung disease that may interfere with the detection or management of drug-related pulmonary toxicity and seriously affect respiratory function. 7. Any serious active infection. 8. With uncontrolled or significant cardiovascular and cerebrovascular disease. 9. Active autoimmune disease requiring systemic treatment. 10. Immunosuppressant or systemic hormone therapy (dose \>10 mg/ day prednisone or other therapeutic hormone) for immunosuppression within 14 days prior to randomization.

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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

    1 site. 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

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Contacts and locations

Locations

  • Tianjin cancer hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300060, China

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