NCT06123754RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 25 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 390 (estimated)
- First submitted
- 25 Oct 2023
- Start date
- 17 Nov 2023
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- 3D Medicines (Sichuan) Co., Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT06123754
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 390
- From 17 Nov 2023 to the primary completion date, 30 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with another drug that targets T cell receptors (e.g. CTLA-4, OX-40, etc.);
- Previous anti-tumor therapy for the disease.
- Immunosuppressant or systemic hormone therapy (dose \>10 mg/ day prednisone or other therapeutic hormone) for immunosuppression within 14 days prior to randomization.
Other illness
- Upper lung sulcus tumor or locally advanced unresectable or metastatic 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.
Lab values
- Participants with known EGFR mutation or ALK translocation, and non-squamous cell carcinoma subjects need to identify EGFR and ALK mutation status;
Other
- Tumor histologically or cytologically confirmed or combined with neuroendocrine carcinoma components, or sarcomatous/sarcomatoid lesions, or adenosquamous carcinoma, or special pathological types.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Cancer Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.