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

3

3D Medicines

Status and phase

Enrolling
Phase 3

Conditions

Non-small Cell Lung Cancer

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT06123754
KN035-CN-017

Details and patient eligibility

About

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.

Full 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.

Enrollment

390 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

390 participants in 2 patient groups

Envalfolimab plus platinum-based doublet chemotherapy
Experimental group
Description:
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.
Treatment:
Drug: Envalfolimab subcutaneously injected+Platinum-based doublet chemotherapy intravenous injection
Placebo plus platinum-based doublet chemotherapy
Active Comparator group
Description:
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.
Treatment:
Drug: placebo subcutaneously injected +Platinum-based doublet chemotherapy intravenous injection

Trial contacts and locations

1

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Central trial contact

Changli Wang

Data sourced from clinicaltrials.gov

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