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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
390
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.
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.
Tianjin cancer hospital
Tianjin, Tianjin Municipality, China
RECRUITINGMPR 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)
Time frame: 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.
Time frame: Up to 5 years
pCR
pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy, assessed by BIPR;
Time frame: Up to 5 years
DFS
DFS is defined as the time from post-surgery to radiographic disease progression, local or distant recurrence, or death from any cause, assessed by BIRC;
Time frame: Up to 5 years
OS
OS is defined as the time from randomization until death from any cause.;
Time frame: Up to 5 years
EFS
EFS is defined as the time from randomization until the occurrence of events leading to inoperable disease progression, post-operative disease progression or recurrence/metastasis, or death from any cause., assessed by investigator;
Time frame: Up to 5 years
Explore the quality of life for subjects by EORTC QLQ-C30
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Time frame: Up to 5 years
Explore the quality of life for subjects by EORTC QLQ-LC13
All of the scales and single-item measures range in score from 0 to 100. A high score for the scales and single items represents a high level of symptomatology or problems.
Time frame: Up to 5 years
PD-L1, ctDNA
To explore the correlation between clinical efficacy and tumor tissue sample biomarkers (such as PD-L1 level, etc.) and blood sample biomarkers (such as ctDNA level, etc.)
Time frame: Up to 5 years