AK112 Neoadjuvant/Adjuvant Treatment for Resectable NSCLC

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Resectable Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin; Drug: AK112

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China
      • Tianjin Medical University Cancer Institute & Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

1. Is currently participating in a study of an investigational agent or using an investigational device
2. Has an active autoimmune disease that has required systemic treatment in the past 2 years
3. Has an active infection requiring systemic therapy
4. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected)
5. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
6. Has received a live virus vaccine within 30 days prior to first dose of study treatment
7. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: AK112; IV infusion
Experimental: 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)	Drug: Paclitaxel; IV infusion; Drug: Carboplatin; IV infusion; Drug: Cisplatin; IV infusion; Drug: AK112; IV infusion

What is the study measuring?

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
MPR	Proportion of subjects with ≤10% residual live tumor cells in resected primary tumor foci and lymph nodes	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

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

Collaborators and Investigators

• Sponsor: Akeso
• Investigators: Principal Investigator: Changli Wang, Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2022
• Primary Completion (Actual): August 18, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Taxoids; Cyclodecanes; Diterpenes; Platinum Compounds; Carboplatin; Paclitaxel; Cisplatin
• Other Study ID Numbers: AK112-205

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No