RecruitingPhase 2NCT07408635

IBI363 (PD-1/IL-2α-bias) in Combination With Chemotherapy as Neoadjuvant Therapy in Initially Unresectable Stage III Non-Small Cell Lung Cancer

IBI363 (PD-1/IL-2α-bias) in Combination With Chemotherapy as Neoadjuvant Therapy to Convert Initially Unresectable Stage III Non-Small Cell Lung Cancer To Resectable Disease: a Phase II, Single-Arm Clinical Trial


Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Enrollment

43 participants

Start Date

Jan 7, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a single-arm, phase II clinical trial evaluating the safety and efficacy of IBI363 combined with chemotherapy as a neoadjuvant treatment of non-small cell lung cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of a new immunotherapy drug (IBI363, which activates the immune system against cancer) with standard chemotherapy as a pre-surgery treatment (neoadjuvant therapy) for patients with Stage III non-small cell lung cancer (NSCLC) that cannot be surgically removed initially. **You may be eligible if...** - You are 18 or older with good overall health (ECOG 0-1) - You have Stage III NSCLC (squamous or non-squamous) that is not surgically removable - This is your first treatment — you have not had any prior chemotherapy, immunotherapy, or radiation - You have adequate heart, liver, and kidney function - Your tumor does not have specific genetic mutations (EGFR, ALK) that have approved targeted therapies **You may NOT be eligible if...** - Your tumor has driver mutations (like EGFR or ALK) that are targeted by approved drugs - You have active autoimmune disease or are on immune-suppressing medications - You have had a recent heart attack, stroke, or uncontrolled high blood pressure - You have active hepatitis B, C, or HIV - You have current or prior lung inflammation (pneumonitis or pulmonary fibrosis) - You are pregnant or breastfeeding 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

DRUGIBI363 + Chemotherapy

1. Neoadjuvant treatment: IBI363 combined with platinum-based chemotherapy. 2. Multidisciplinary team(MDT) assessment: Participants deemed operable by the MDT will undergo surgery, and then can continue to receive standard adjuvant therapy for one year. If the NSCLC remained unresectable, concurrent chemoradiotherapy was administered followed by immune checkpoint inhibitor consolidation therapy to maintain.


Locations(1)

Shanghai Pulmonary Hospital

Shanghai, China

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NCT07408635


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