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This is a Phase 2 study to evaluate the safety, and efficacy of IBI363 as Neoadjuvant Therapy in Resectable Stage II-III Non-Small Cell Lung Cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant Therapy | Experimental | Neoadjuvant therapy period : Subjects will receive IBI363 for up to 4 cycles before surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI363 | Drug | Subjects will receive IBI363 for up to 4 cycles, each cycle is 21 days, the first treatment cycle is 28 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response (pCR) rate | pCR rate is defined as no residual invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after neoadjuvant therapy | Up to approximately 8 weeks following completion of neoadjuvant treatment |
| Safety parameters: the incidence of Treatment-related Adverse Event, (TRAEs) | up to 90 days after the last dose | |
| Safety parameters: the incidence of treatment-emergent adverse events (TEAEs) | up to 90 days after the last dose | |
| Safety parameters: the incidence of immune-related adverse events (irAEs) | up to 90 days after the last dose | |
| Safety parameters: the incidence of adverse events of special interest (AESIs) | up to 90 days after the last dose | |
| Safety parameters: the incidence of serious adverse events (SAE) | up to 90 days after the last dose | |
| Safety parameters: the relatedness of infusion-related reactions (IRRs) to the investigational product and their severity | up to 90 days after the last dose | |
| Safety parameters: the surgery delay rate | Up to approximately 8 weeks following completion of neoadjuvant treatment | |
| Proportion of subjects with abnormal and clinically significant results including routine blood tests, blood biochemical tests, coagulation tests,, routine urine tests, pregnancy tests,ECG, etc |
| Measure | Description | Time Frame |
|---|---|---|
| Event Free Survival (EFS) | EFS is defined as the time from the first dose to the first determination by the investigator with RECIST v1.1 of inoperable disease progression, postoperative local recurrence or distant metastasis, development of another primary tumor, or death from any cause, whichever occurred first. | Up to approximately 5 years |
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Inclusion Criteria:
Males and Females, age ≥18 years and ≤75 years;
Histologically or cytologically confirmed primary NSCLC:
Participants without EGFR mutations or ALK translocation;
PD-L1 expression: TPS≥1%
At least 1 measurable lesion per RECISIT v1.1;
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
Adequate organ function confirmed at screening period.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoqin Ruan | Contact | 0512-69566088-8095 | xiaoqin.ruan@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China |
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| up to 90 days after the last dose |
| Major Pathological Response (mPR) Rate | mPR rate is defined as ≤ 10% residual invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after neoadjuvant therapy. | Up to approximately 8 weeks following completion of neoadjuvant treatment |
| Objective Response Rate (ORR)Rate | ORR is defined as the proportion of subjects assessed by the investigators as achieving complete response (CR) or partial response (PR) according to the RECIST v1.1 criteria. | Up to approximately 5 years |
| Disease Control Rate (DCR) Rate | Up to approximately 5 years |
| R0 resection rate | Up to approximately 8 weeks following completion of neoadjuvant treatment |