Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC

NCT ID: NCT06123754

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 390 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-17
• Study Completion Date: 2027-09-30

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.

Detailed Description

A total of approximately 390 participants are planned to be enrolled in this study. After being screened and qualified, the subjects will be randomly assigned to receive Envalfolimab or placebo plus platinum-based doublet chemotherapy in 1:1 ratio for a total of 3-4 cycles of neoadjuvant therapy (determined by the investigator), the feasibility of surgery is evaluated by the investigator within 4-6 weeks after the end of neoadjuvant therapy and surgery will be performed. Envafolimab (experimental group) or placebo (control group) will be administered after surgery. After completion of treatment, subjects will enter a follow-up phase, including safety follow-up, tumor disease follow-up, and survival follow-up.All randomized subjects in this study are required to receive tumor imaging evaluation as scheduled and get continuous safety assessment during the srceening and treatment period.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Envalfolimab plus platinum-based doublet chemotherapy

Envalfolimab plus platinum-based doublet chemotherapy for a total of 3-4 cycles of neoadjuvant therapy (determined by the investigator), Envafolimab will be administered after surgery at 600 mg every 3 weeks(Q3W) for 16 cycles at most.

Group Type: EXPERIMENTAL

Envalfolimab subcutaneously injected+Platinum-based doublet chemotherapy intravenous injection

Intervention Type: DRUG

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 plus platinum-based doublet chemotherapy

Placebo plus platinum-based doublet chemotherapy for a total of 3-4 cycles of neoadjuvant therapy (determined by the investigator), placebo will be administered after surgery every 3 weeks(Q3W) for 16 cycles at most.

Group Type: ACTIVE_COMPARATOR

placebo subcutaneously injected +Platinum-based doublet chemotherapy intravenous injection

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Experimental; Active Comparator

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

3D Medicines (Sichuan) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Changli Wang

Role: PRINCIPAL_INVESTIGATOR

Tianjin Cancer Hospital

Locations

Tianjin cancer hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Changli Wang

Role: CONTACT

Wangchangli@tjmuch.com

0086-22-2340123

Facility Contacts

Changli Wang

Role: primary

Wangchangli@tjmuch.com

0086-22-2340123

Other Identifiers

KN035-CN-017

Identifier Type: -

Identifier Source: org_study_id