New drug combo aims to shrink lung tumors before surgery
NCT ID NCT06123754
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 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: 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Non-small cell lung cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Tianjin cancer hospital
RECRUITINGTianjin, Tianjin Municipality, 300060, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo targets stubborn KRAS lung cancer
- 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?
- Two-Drug combo takes aim at Hard-to-Treat lung cancer