Envalfolimab subcutaneously injected+Platinum-based doublet chemotherapy intravenous injection: 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.
placebo subcutaneously injected +Platinum-based doublet chemotherapy intravenous injection: 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.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
MPR by BIPR — Up to 5 years MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy (evaluated by BIPR)
EFS by BIRC — Up to 5 years EFS is defined as the time from randomization until the occurrence of events leading to inoperable disease progression, post-operative disease progression (BIRC assessment based on RECIST 1.1) or recurrence/metastasis, or death from any cause.
Trial sites (1)
Facility
City
Region
Status
Tianjin cancer hospital
Tianjin
Tianjin Municipality
Recruiting
More 3D Medicines (Sichuan) Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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