Envafolimab with chemotherapy for resectable stage III lung cancer

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

This study is testing if adding a new drug called envafolimab to standard chemotherapy can help people with resectable stage III lung cancer do better before and after surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 390 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: 3D Medicines (Industry-sponsored)
• Drugs / interventions: Radiation, prednisone, envafolimab, chemotherapy, Envalfolimab
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT06123754 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical study evaluates the effectiveness and safety of envafolimab combined with platinum-based chemotherapy compared to a placebo with the same chemotherapy in patients with resectable stage IIIA and IIIB non-small cell lung cancer (NSCLC). Approximately 390 participants will be randomly assigned to receive either the experimental treatment or placebo for 3-4 cycles before surgery. Following surgery, participants will continue to receive either envafolimab or placebo. The study aims to assess the major pathological response rate and event-free survival through rigorous follow-up and imaging evaluations.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of resectable stage IIIA-IIIB NSCLC and good overall health.

Not a fit: Patients with certain types of lung cancer, such as neuroendocrine carcinoma or those who have previously received similar immunotherapy treatments, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with resectable stage III NSCLC.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in lung cancer, indicating potential for success in this trial.

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.

Where this trial is running

Tianjin, Tianjin Municipality

• Tianjin cancer hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Principal investigator: Changli Wang — Tianjin Cancer Hospital
• Study coordinator: Changli Wang

Conditions Non-small Cell Lung Cancer; Envafolimab