AK112 Neoadjuvant/Adjuvant Treatment for Resectable NSCLC

Study Overview
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Brief Summary
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AK112, alone or in combination with chemotherapy for the neoadjuvant/adjuvant treatment of resectable NSCLC

Detailed Description
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Phase II clinical study of AK112, an anti-PD-1 and VEGF bispecific antibody, alone or in combination with chemotherapy for the neoadjuvant/adjuvant treatment of resectable non-small cell lung cancer

Official Title
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Phase II Clinical Study of AK112, an Anti-PD-1 and VEGF Bispecific Antibody, Alone or in Combination With Chemotherapy for the Neoadjuvant/Adjuvant Treatment of Resectable Non-small Cell Lung Cancer

Conditions
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Resectable Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: AK112
* Drug: Carboplatin
* Drug: Cisplatin
* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1、18 to 75 years old 2、Be able and willing to provide written informed consent and to comply with all requirements of study participation 3、Histologically confirmed resectable stage II-IIIB NSCLC 4、Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 5、Has adequate organ function 6、All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment. Exclusion Criteria: Is currently participating in a study of an investigational agent or using an investigational device Has an active autoimmune disease that has required systemic treatment in the past 2 years Has an active infection requiring systemic therapy Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected) Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study Has received a live virus vaccine within 30 days prior to first dose of study treatment Is pregnant, breastfeeding, or expecting to conceive or father a child within the projected duration of the study including 120 days following the last dose of study treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: arm 1(AK112)<br>Neoadjuvant therapy was 3-4 cycles of AK112(Q3W), followed by surgery ,followed by adjuvant therapy for 16 cycles of AK112(Q3W) | Drug: AK112<br>* IV infusion<br>|
| Experimental: arm 2(AK112+Carboplatin/cisplatin + paclitaxel)<br>Neoadjuvant therapy was 3-4 cycles of AK112 plus Carboplatin/cisplatin + paclitaxel(Q3W), followed by surgery ,followed by adjuvant therapy for 16 cycles of AK112(Q3W) | Drug: AK112<br>* IV infusion<br>Drug: Carboplatin<br>* IV infusion<br>Drug: Cisplatin<br>* IV infusion<br>Drug: Paclitaxel<br>* IV infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events (AE) | Summary of AE incidence; summary after grading of AE according to NCI CTCAE version 5.0 | Up to approximately 2 years | 
| rate of surgical delays | Proportion of subjects exceeding the maximum surgical time window | Up to approximately 2 years | 
| abnormal laboratory findings of clinical significance | Proportion of subjects with abnormal and clinically significant results including routine blood tests, blood biochemical tests, coagulation tests, thyroid function tests, routine urine tests, pregnancy tests, etc. | Up to approximately 2 years | 
| MPR | Proportion of subjects with ≤10% residual live tumor cells in resected primary tumor foci and lymph nodes | Up to approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R0 resection rate | Proportion of subjects with pathologically complete resection of primary tumors | Up to approximately 2 years | 
| Tumor descending stage rate | Proportion of subjects with the most recent tumor staging prior to surgery (using TNM staging version 8) who were down-staged relative to baseline | Up to approximately 2 years | 
| pCR | Proportion of subjects with no residual tumor in the resected tumor primary and lymph nodes | Up to approximately 2 years | 
| OS | Time from first dose until death from any cause | Up to approximately 2 years | 
| EFS | Time from first dose to the occurrence of any of the following events, whichever occurs first: disease progression, local recurrence or distant metastasis or death from any cause, as assessed according to RECIST v1.1. | Up to approximately 2 years | 
| ORR | ORR is the proportion of subjects with CR or PR,based on recist v1.1 | Up to approximately 2 years |