To hear about similar clinical trials, please enter your email below
Trial Title:
Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC
NCT ID:
NCT06123754
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Envafolimab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This study is a randomized, controlled, double-blind, multicenter phase Ⅲ study
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Envalfolimab subcutaneously injected+Platinum-based doublet chemotherapy intravenous injection
Description:
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.
Arm group label:
Envalfolimab plus platinum-based doublet chemotherapy
Other name:
Experimental
Intervention type:
Drug
Intervention name:
placebo subcutaneously injected +Platinum-based doublet chemotherapy intravenous injection
Description:
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.
Arm group label:
Placebo plus platinum-based doublet chemotherapy
Other name:
Active Comparator
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin cancer hospital
Address:
City:
Tianjing
Zip:
300060
Country:
China
Status:
Recruiting
Contact:
Last name:
Changli Wang
Phone:
0086-22-2340123
Email:
Wangchangli@tjmuch.com
Start date:
November 17, 2023
Completion date:
September 30, 2027
Lead sponsor:
Agency:
3D Medicines (Sichuan) Co., Ltd.
Agency class:
Industry
Source:
3D Medicines
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06123754
