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
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Rate of surgical delays
Study Overview
Brief Summary
AK112, alone or in combination with chemotherapy for the neoadjuvant/adjuvant treatment of resectable NSCLC
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 to 75 years old
- •Be able and willing to provide written informed consent and to comply with all requirements of study participation
- •Histologically confirmed resectable stage II-IIIB NSCLC
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Has adequate organ function
- •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.
Arms & Interventions
arm 2(AK112+Carboplatin/cisplatin + paclitaxel)
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)
Intervention: Cisplatin (Drug)
arm 1(AK112)
Neoadjuvant therapy was 3-4 cycles of AK112(Q3W), followed by surgery ,followed by adjuvant therapy for 16 cycles of AK112(Q3W)
Intervention: AK112 (Drug)
arm 2(AK112+Carboplatin/cisplatin + paclitaxel)
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)
Intervention: AK112 (Drug)
arm 2(AK112+Carboplatin/cisplatin + paclitaxel)
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)
Intervention: Paclitaxel (Drug)
arm 2(AK112+Carboplatin/cisplatin + paclitaxel)
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)
Intervention: Carboplatin (Drug)
Outcomes
Primary Outcomes
Rate of surgical delays
Time Frame: Up to approximately 2 years
Proportion of subjects exceeding the maximum surgical time window
Abnormal laboratory findings of clinical significance
Time Frame: Up to approximately 2 years
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.
Major pathological response (MPR)
Time Frame: Up to approximately 2 years
Proportion of subjects with ≤10% residual live tumor cells in resected primary tumor and lymph nodes
Incidence and severity of adverse events (AE)
Time Frame: Up to approximately 2 years
Summary of AE incidence; summary after grading of AE according to NCI CTCAE version 5.0
Secondary Outcomes
- Pathological complete response (pCR)(Up to approximately 2 years)
- Overall survival (OS)(Up to approximately 2 years)
- Event free survival (EFS)(Up to approximately 2 years)
- Objective response rate (ORR)(Up to approximately 2 years)
- R0 resection rate(Up to approximately 2 years)
- Tumor descending stage rate(Up to approximately 2 years)