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

NCT06123754 | Recruiting Phase 3 DMC

• 1 other identifier: KN035-CN-017
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Envafolimab

Outcome Measures

Primary Outcomes (2)

• MPR by BIPR

  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)

  Up to 5 years

• EFS by BIRC

  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.

  Up to 5 years

Secondary Outcomes (7)

• pCR

  Up to 5 years

• DFS

  Up to 5 years

• OS

  Up to 5 years

• EFS

  Up to 5 years

• Explore the quality of life for subjects by EORTC QLQ-C30

  Up to 5 years

Study Arms (2)

Envalfolimab plus platinum-based doublet chemotherapy

EXPERIMENTAL

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.

Drug: Envalfolimab subcutaneously injected+Platinum-based doublet chemotherapy intravenous injection

Placebo plus platinum-based doublet chemotherapy

ACTIVE COMPARATOR

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.

Drug: placebo subcutaneously injected +Platinum-based doublet chemotherapy intravenous injection

Interventions

Envalfolimab subcutaneously injected+Platinum-based doublet chemotherapy intravenous injection 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.

Also known as: Experimental

Envalfolimab plus platinum-based doublet chemotherapy

placebo subcutaneously injected +Platinum-based doublet chemotherapy intravenous injection 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.

Also known as: Active Comparator

Placebo plus platinum-based doublet chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Tumor histologically or cytologically confirmed or combined with neuroendocrine carcinoma components, or sarcomatous/sarcomatoid lesions, or adenosquamous carcinoma, or special pathological types.
• Previous treatment with another drug that targets T cell receptors (e.g. CTLA-4, OX-40, etc.);
• Participants with known EGFR mutation or ALK translocation, and non-squamous cell carcinoma subjects need to identify EGFR and ALK mutation status;
• Upper lung sulcus tumor or locally advanced unresectable or metastatic disease.
• Previous anti-tumor therapy for the 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.
• Immunosuppressant or systemic hormone therapy (dose \>10 mg/ day prednisone or other therapeutic hormone) for immunosuppression within 14 days prior to randomization.

Sponsors & Collaborators

• 3D Medicines (Sichuan) Co., Ltd.: lead

Study Sites (1)

Tianjin cancer hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Changli Wang

  Tianjin Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Changli Wang

CONTACT

0086-22-2340123; Wangchangli@tjmuch.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a randomized, controlled, double-blind, multicenter phase Ⅲ study

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: November 9, 2023
• Study Start: November 17, 2023
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

CN (1)