Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a randomized, open-label Phase 2 study to compare the efficacy and safety of IBI363 Combined with Chemotherapy or Pembrolizumab Combined with Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI363 | Experimental | Neoadjuvant Treatment period: up to 3 cycles of IBI363 plus platinum-based chemotherapy prior to surgery. |
|
| Keytruda | Active Comparator | Neoadjuvant Treatment period: up to 3 cycles of Keytruda plus platinum-based chemotherapy prior to surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pemetrexed | Drug | 500 mg/m2 D1 IV Q3W |
| |
| 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 all adverse events (AEs) | 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 |
Not provided
Inclusion Criteria:
Males and Females, age ≥18 years and ≤75 years;
Histologically or cytologically confirmed primary non-squamous NSCLC:
Participants without EGFR mutations or ALK translocation;
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:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| wei zhang | Contact | 15005136320 | wei.zhang02@innoventbio.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liaoning Cancer Hospital and Institute | Recruiting | Shenyang | Liaoning | 110000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cisplatin |
| Drug |
75 mg/m2 D1 IV Q3W |
|
| IBI363 | Drug | 1.5 mg/kg D1 IV Q3W |
|
| Carboplatin | Drug | AUC 5 mg/ml/min D1 IV Q3W |
|
| Keytruda | Drug | 200mg D1 IV Q3W |
|
| 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 | ORR is defined as the proportion of subjects assessed by the investigators as achieving complete response (CR) 、partial response (PR) or stable Disease(SD) according to the RECIST v1.1 criteria. | Up to approximately 5 years |
| R0 resection rate | R0 resection rate is defined as negative margins, systematic lymph node dissection or sampling, and tumor-negative highest mediastinal lymph nodes. | Up to approximately 8 weeks following completion of neoadjuvant treatment |
| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| C582435 | pembrolizumab |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
Not provided
Not provided