This trial will evaluate the safety and efficacy of Camrelizumab (SHR-1210) in combination with apatinib neoadjuvant therapy before surgery \[neoadjuvant phase\], followed by camrelizumab alone after surgery \[adjuvant phase\] in participants with resectable stage IIA-IIIA, and resectable IIIB (T3N2) non-small cell lung cancer (NSCLC).
This trial will evaluate the safety and efficacy of camrelizumab in combination with apatinib neoadjuvant chemotherapy (NAC) before surgery \[neoadjuvant phase\], followed by camrelizumab alone after surgery \[adjuvant phase\] in participants with resectable stage II, IIIA, and resectable IIIB (T3N2) non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant camrelizumab in combination with apatinib, followed by surgery and adjuvant camrelizumab will improve: 1)MPR assessed by investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) ; 2) event free survival (EFS) and 3) overall survival (DFS).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
74
Major Pathological Response (MPR) Rate
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
Time frame: Up to 8weeks following completion of neoadjuvant treatment (up to Study Week 12)
Pathological Complete Response (pCR) Rate
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.
Time frame: Up to 8weeks following completion of neoadjuvant treatment (up to Study Week 12)
Event Free Survival (EFS)
EFS is defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause. EFS determined by biopsy assessed by investigator using RECIST 1.1 .
Time frame: up to 5 years
Objective Response (OR)
Objective response is defined as a complete response or partial response, as determined by the investigator according to RECIST v1.1
Time frame: up to 6 weeks
Disease-Free Survival (DFS)
DFS is defined as the time from the first date of no disease to local or distant recurrence or death due to any cause, whichever occurs first, as determined by the investigator during the adjuvant treatment and observation follow-up
Time frame: up to 5 years
Adverse Events (AEs)
The number of participants experiencing an AE will be assessed
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Time frame: up to 17 weeks