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AK112 Neoadjuvant/Adjuvant Treatment for Resectable NSCLC | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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

NCT05247684•Akeso

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

February 20, 2022

Primary Completion Date

August 18, 2025

Completion Date

December 31, 2026

Last Updated

March 5, 2026

Enrollment

ACTUAL participants

Conditions

Resectable Non-small Cell Lung Cancer

Interventions

AK112

DRUG

Carboplatin

DRUG

Cisplatin

DRUG

Paclitaxel

DRUG

An Observational Study to Evaluate Neoadjuvant Nivolumab (OPDIVO®) in Combination With Platinum-Based Chemotherapy in Non-Metastatic Non-Small Cell Lung Cancer Participants in Germany

NCT06169956

Resectable Non-small Cell Lung Cancer

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ACTIVE_NOT_RECRUITINGPHASE2

A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery

NCT06161441

Resectable Non-small Cell Lung Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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AK112 Neoadjuvant/Adjuvant Treatment for Resectable NSCLC

Inclusion Criteria

Exclusion Criteria

An Observational Study to Evaluate Neoadjuvant Nivolumab (OPDIVO®) in Combination With Platinum-Based Chemotherapy in Non-Metastatic Non-Small Cell Lung Cancer Participants in Germany

A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery

Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments

Ivonescimab Monotherapy or in Combination With Chemotherapy as Neoadjuvant/Adjuvant Therapy for Resectable Non-small Cell Lung Cancer

A Multicenter Phase II Randomized Trial of Limertinib Followed by Sintilimab and Chemotherapy vs. Limertinib Followed by Limertinib and Chemotherapy as Neoadjuvant Therapy in Resectable Stage II-IIIB EGFR-Mutant NSCLC

Comparison of Neoadjuvant Cadonilimab Versus Chemotherapy Combined With PD-1 in the Treatment of Resectable Non-Small Cell Lung Cancer With High PD-L1 Expression: A Single-Center, Randomized, Exploratory Clinical Study