Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC
A Randomized, Controlled, Double-blind, Multicenter Phase III Clinical Study of Envafolimab Plus Platinum-based Doublet Chemotherapy Versus Placebo Plus Platinum-based Doublet Chemotherapy in Patients With Non-small Cell Lung Cancer
3D Medicines (Sichuan) Co., Ltd.
390 participants
Nov 17, 2023
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria9
- 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 Criteria10
- 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.
Interventions
The subjects receive Envafolimab/placebo treatment with a dosage of 600 mg/3 ml subcutaneously injected every 3 weeks.It will last about 3-4 cycles before surgery and 16 cycles after surgery.
The subjects received platinum-based doublet chemotherapy on day 1 of every cycle. It's 3 weeks per cycle and lasts 3-4 cycles before surgery.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06123754