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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| apatinib+ Neoadjuvant/Adjuvant camrelizumab | Experimental | Neoadjuvant: Prior to surgery, participants receive 3 cycles (cycle length: 2 weeks) of camrelizumab [200 mg, intravenous (IV); given on cycle day 1] in combination with apatinib ,5 days on 2days off]. Adjuvant: 4-8 weeks following surgery, participants receive up to 12 cycles (cycle length: 2 weeks) of camrelizumab [200 mg, IV; given on cycle day 1]. Participants who can not able to benefit from immunotherapy will not receive camrelizumab adjuvant therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1210 | Drug | PD-1 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 8weeks following completion of neoadjuvant treatment (up to Study Week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 8weeks following completion of neoadjuvant treatment (up to Study Week 12) |
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Inclusion Criteria:
8. Patients who have not received anti-tumor treatment for NSCLC; 9. Patients with normal function of main organs; 10. The fertile female patients must carry out the serum pregnancy test within 72 hours before the first medication, and the result is negative. The fertile female subjects and the male subjects whose partners are fertile females must agree to use efficient methods of contraception and lactation during the study period and within 90 days after the last administration of the study drug.
Exclusion Criteria:
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
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| Apatinib | Drug | VEGFR2 |
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| 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 . |
| 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 | 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 | up to 5 years |
| Adverse Events (AEs) | The number of participants experiencing an AE will be assessed | up to 17 weeks |