Actively Recruiting
Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC
Led by 3D Medicines (Sichuan) Co., Ltd. · Updated on 2026-03-25
390
Participants Needed
1
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, controlled, double-blind, multicenter Phase 3 clinical study to assess the efficacy and safety of envafolimab plus platinum-based doublet chemotherapy versus placebo plus platinum-based doublet chemotherapy as neoadjuvant/adjuvant therapy in subjects with resectable stage IIIA and IIIB (N2) NSCLC. Primary study endpoints are MPR rate assessed by BIPR and EFS assessed by BIRC.
CONDITIONS
Official Title
Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteer to participate and sign the informed consent form.
- Age 18 years or older.
- Histological and/or cytological diagnosis of resectable stage IIIA-IIIB (N2) non-small cell lung cancer.
- Measurable lesions based on RECIST 1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Ability to provide tumor tissue for PD-L1 expression testing.
- Sufficient organ and bone marrow function.
- Expected survival of at least 6 months.
- Surgeon assessment that lung function allows for proposed pneumonectomy.
You will not qualify if you...
- Tumor with neuroendocrine carcinoma components, sarcomatous/sarcomatoid lesions, adenosquamous carcinoma, or special pathological types.
- Previous treatment with drugs targeting T cell receptors (e.g., CTLA-4, OX-40).
- Known EGFR mutation or ALK translocation; non-squamous cell carcinoma must have EGFR and ALK mutation status identified.
- Upper lung sulcus tumor, locally advanced unresectable, or metastatic disease.
- Prior anti-tumor therapy for this lung cancer.
- Known or suspected interstitial pneumonia, radiation pneumonia, or moderate to severe lung disease affecting respiratory function.
- Any serious active infection.
- Uncontrolled or significant cardiovascular or cerebrovascular disease.
- Active autoimmune disease requiring systemic treatment.
- Use of immunosuppressants or systemic hormone therapy (over 10 mg/day prednisone or equivalent) within 14 days prior to randomization.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin cancer hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
C
Changli Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here