RecruitingPhase 2NCT05377658

AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer

A Single-Arm, Phase II Study of AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer


Sponsor

Henan Cancer Hospital

Enrollment

43 participants

Start Date

Jul 26, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

AK104, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. The aim of this study is to evaluate the efficacy and safety of AK104 with chemotherapy as neoadjuvant and adjuvant therapy for patients with resectable stage II-IIIA NSCLC.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug (AK104, a dual checkpoint inhibitor) to standard chemotherapy before and after surgery can improve outcomes for patients with early-stage, surgically removable non-small cell lung cancer (NSCLC). **You may be eligible if...** - You have Stage II or IIIA non-small cell lung cancer that can be surgically removed - You have not previously received any treatment for this lung cancer - You have at least one measurable tumor lesion - You are in good overall health (ECOG performance status 0 or 1) **You may NOT be eligible if...** - You have a mixed lung cancer type (NSCLC + small cell) - You have had another active cancer in the past 3 years - You have known autoimmune disease - You have been on immunosuppressant medications recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAK104

10 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.

DRUGAlbumin-Bound Paclitaxel

260mg/m\^2 via intravenous infusion on Day 1 of each 21-day cycle.

DRUGCarboplatin

AUC 5 mg/mL/min via intravenous infusion on Day 1 of each 21-day cycle.


Locations(1)

Henan Cancer Hospital

Zhengzhou, Henan, China

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NCT05377658


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