RecruitingPhase 2NCT06769295

A Phase II Study of AK112 (PD1/VEGF Bispecific) in Combination with Chemotherapy in Patients with NSCLC

A Phase II Study of AK112 (PD-1/VEGF Bispecific) in Combination with Chemotherapy for Patients with Advanced Non-squamas Non-mall Cell Lung Cancer and Malignant Pleural Effusion


Sponsor

Sichuan University

Enrollment

28 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Summary

This is a phase II study. All patients are stage IV non-squamas non-small cell lung cancer(NSCLC) with malignant pleura effusion, Eastern Cooperative Oncology Group (ECOG) performance status 0-2. The purpose of this study is to evaluate the efficacy and safety of AK112 in combination with chemotherapy in patients with NSCLC with malignant pleura effusion.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing AK112 — a drug that simultaneously blocks both PD-1 (immune checkpoint) and VEGF (tumor blood supply) — combined with chemotherapy in patients with stage IV non-squamous non-small cell lung cancer (NSCLC) that has spread to the lining around the lungs (malignant pleural effusion). **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with stage IV non-squamous NSCLC confirmed by biopsy - Your cancer has spread to the pleural space around the lungs (malignant pleural effusion confirmed by cytology or imaging) - Your cancer does not have known driver gene mutations (such as EGFR, ALK, ROS1) - Your general health is good (ECOG score 0-2) with adequate organ function **You may NOT be eligible if...** - Your lung cancer has a targetable driver mutation for which a specific approved therapy exists - You have already received systemic treatment for advanced NSCLC - You have active or poorly controlled autoimmune disease - Your lung or organ function is too compromised to handle chemotherapy 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

DRUGAK112

non-Squamous NSCLC with malignant pleura effusions:Subjects receive AK112 plus Pemetrexed and Carboplatin/Cisplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK112 plus Pemetrexed until progression.


Locations(1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

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NCT06769295