Envafolimab with chemotherapy for resectable stage III lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 clinical study evaluates the effectiveness and safety of envafolimab combined with platinum-based chemotherapy compared to a placebo with the same chemotherapy in patients with resectable stage IIIA and IIIB non-small cell lung cancer (NSCLC). Approximately 390 participants will be randomly assigned to receive either the experimental treatment or placebo for 3-4 cycles before surgery. Following surgery, participants will continue to receive either envafolimab or placebo. The study aims to assess the major pathological response rate and event-free survival through rigorous follow-up and imaging evaluations.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tianjin cancer hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: Changli Wang — Tianjin Cancer Hospital Airport Hospital
• Study coordinator: Changli Wang
• Email: Wangchangli@tjmuch.com
• Phone: 0086-22-2340123

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combination treatment for resectable HER2-mutant non-small cell lung cancer

  This study is testing a new combination treatment for people with resectable HER2-mutant non-small cell lung cancer to see if it can improve their chances of recovery after surgery.

  Recruiting Phase 2 Guangdong Provincial People's Hospital · Guangzhou · NCT06734182

• Combining Envafolimab and Lenvatinib for treating advanced solid tumors

  This study is testing if combining two drugs, Envafolimab and Lenvatinib, can help people with advanced solid tumors feel better when other treatments haven't worked.

  Recruiting at 16 sites Phase 1/2 3D Medicines · Bengbu, Anhui and 22 other locations · NCT05024214

• Patient-specific MRD liquid biopsy for resected NSCLC

  This study tests a personalized MRD blood and bronchial washing test after surgery to see if it can signal recurrence earlier in people with resected NSCLC.

  Recruiting Yonsei University · Yongin-si, Gyeonggi-do and 2 other locations · NCT07921888

• Osimertinib Plus SRS/SRT for EGFR-Mutant NSCLC with Symptomatic Brain Metastases

  This study tests whether adding targeted brain radiotherapy to osimertinib helps control brain metastases in adults with EGFR-mutant NSCLC and neurological symptoms.

  Recruiting Phase 2 Cho Ray Hospital · Ho Chi Minh City · NCT07911449

• Dato-DXd in solid tumors (Urothelial Cancer and KRAS-mutant NSCLC) in two sub-studies

  This study tests Datopotamab Deruxtecan (Dato-DXd) alone or with other cancer drugs in people with urothelial cancer or KRAS-mutant non-small cell lung cancer.

  Recruiting Phase 1/2 Daiichi Sankyo · Taichung · NCT07890714

• SI-B036 safety test in advanced and metastatic solid tumors

  This early-phase study checks whether SI-B036 is safe and tolerable in adults with advanced or metastatic solid cancers who have had prior therapy.

  Recruiting at 4 sites Phase 1 SystImmune Inc. · New Haven, Connecticut and 6 other locations · NCT07857616

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.