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Active, Not Recruiting

NCT Number: NCT05247684

AK112 Neoadjuvant/Adjuvant Treatment for Resectable NSCLC

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Resectable Non-small Cell Lung Cancer

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AK112

Drug

IV infusion

carboplatin

Drug

IV infusion

Cisplatin

Drug

IV infusion

paclitaxel

Drug

IV infusion

Primary outcomes

  1. 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

  2. Rate of surgical delays

    Time frame: Up to approximately 2 years

    Proportion of subjects exceeding the maximum surgical time window

  3. 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.

  4. MPR

    Time frame: Up to approximately 2 years

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

Secondary outcomes

  1. R0 resection rate

    Time frame: Up to approximately 2 years

    Proportion of subjects with pathologically complete resection of primary tumors

  2. Tumor descending stage rate

    Time frame: Up to approximately 2 years

    Proportion of subjects with the most recent tumor staging prior to surgery (using TNM staging version 8) who were down-staged relative to baseline

  3. pCR

    Time frame: Up to approximately 2 years

    Proportion of subjects with no residual tumor in the resected tumor primary and lymph nodes

  4. OS

    Time frame: Up to approximately 2 years

    Time from first dose until death from any cause

  5. EFS

    Time frame: Up to approximately 2 years

    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.

  6. ORR

    Time frame: Up to approximately 2 years

    ORR is the proportion of subjects with CR or PR,based on recist v1.1

Sponsors and collaborators

Lead sponsor

Akeso

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Feb 21, 2022
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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