Status:
RECRUITING
Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC
Lead Sponsor:
3D Medicines (Sichuan) Co., Ltd.
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 platinu...
Detailed Description
A total of approximately 390 participants are planned to be enrolled in this study. After being screened and qualified, the subjects will be randomly assigned to receive Envalfolimab or placebo plus p...
Eligibility Criteria
Inclusion
- Volunteer to participate and sign the informed consent form.
- Age ≥ 18 years old, regardless of gender.
- Histological and/or cytological diagnosis of resectable stage IIIA-IIIB (N2) NSCLC.
- Measurable lesions based on the response evaluation criteria in solid tumors version 1.1（RECIST 1.1）.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Subjects should provide tumor tissue for detection of PD-L1 expression level.
- Sufficient organ and bone marrow function.
- Expected survival ≥6 months.
- The surgeon assessed that total lung function is able to withstand the proposed pneumonectomy procedure.
Exclusion
- Tumor histologically or cytologically confirmed or combined with neuroendocrine carcinoma components, or sarcomatous/sarcomatoid lesions, or adenosquamous carcinoma, or special pathological types.
- Previous treatment with another drug that targets T cell receptors (e.g. CTLA-4, OX-40, etc.);
- Participants with known EGFR mutation or ALK translocation, and non-squamous cell carcinoma subjects need to identify EGFR and ALK mutation status;
- Upper lung sulcus tumor or locally advanced unresectable or metastatic disease.
- Previous anti-tumor therapy for the disease.
- 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.
- Any serious active infection.
- With uncontrolled or significant cardiovascular and cerebrovascular disease.
- Active autoimmune disease requiring systemic treatment.
- Immunosuppressant or systemic hormone therapy (dose \>10 mg/ day prednisone or other therapeutic hormone) for immunosuppression within 14 days prior to randomization.
Key Trial Info
Start Date :
November 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT06123754
Start Date
November 17 2023
End Date
September 30 2027
Last Update
May 20 2025
Active Locations (1)
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1
Tianjin cancer hospital
Tianjin, Tianjin Municipality, China, 300060