NCT06123754 Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC
| NCT ID | NCT06123754 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | 3D Medicines (Sichuan) Co., Ltd. |
| Condition | Non-small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 390 participants |
| Start Date | 2023-11-17 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 390 participants in total. It began in 2023-11-17 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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.
Contact & Investigator
Changli Wang
PRINCIPAL INVESTIGATOR
Tianjin Cancer Hospital
Frequently Asked Questions
Who can join the NCT06123754 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06123754 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 390 participants.
Is NCT06123754 currently recruiting?
Yes, NCT06123754 is actively recruiting participants. Contact the research team at Wangchangli@tjmuch.com for enrollment information.
Where is the NCT06123754 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06123754 clinical trial?
NCT06123754 is sponsored by 3D Medicines (Sichuan) Co., Ltd.. The principal investigator is Changli Wang at Tianjin Cancer Hospital. The trial plans to enroll 390 participants.
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