AK112 Neoadjuvant/Adjuvant Treatment for Resectable NSCLC

NCT05247684 | Active Not Recruiting Phase 2

• 1 other identifier: AK112-205
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Resectable Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• R0 resection rate

  Up to approximately 2 years

• Tumor descending stage rate

  Up to approximately 2 years

• pCR

  Up to approximately 2 years

• OS

  Up to approximately 2 years

• EFS

  Up to approximately 2 years

Study Arms (2)

arm 1(AK112)

EXPERIMENTAL

Neoadjuvant therapy was 3-4 cycles of AK112(Q3W), followed by surgery ,followed by adjuvant therapy for 16 cycles of AK112(Q3W)

Drug: AK112

arm 2(AK112+Carboplatin/cisplatin + paclitaxel)

EXPERIMENTAL

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; Drug: Carboplatin; Drug: Cisplatin; Drug: Paclitaxel

Interventions

AK112 DRUG

IV infusion

arm 1(AK112); arm 2(AK112+Carboplatin/cisplatin + paclitaxel)

Carboplatin DRUG

IV infusion

arm 2(AK112+Carboplatin/cisplatin + paclitaxel)

Cisplatin DRUG

IV infusion

arm 2(AK112+Carboplatin/cisplatin + paclitaxel)

Paclitaxel DRUG

IV infusion

arm 2(AK112+Carboplatin/cisplatin + paclitaxel)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Interventions

Carboplatin; Cisplatin; Paclitaxel

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Changli Wang

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 21, 2022
• Study Start: February 20, 2022
• Primary Completion: August 18, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

CN (1)