RecruitingPhase 2NCT07122687

IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer

A Phase II Study Evaluating the Efficacy and Safety of IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer


Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Enrollment

170 participants

Start Date

Aug 26, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a randomized, open-label Phase 2 study to compare the efficacy and safety of IBI363 Combined with Chemotherapy or Pembrolizumab Combined with Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two pre-surgery (neoadjuvant) treatment combinations — one using a new drug called IBI363 with chemotherapy and another using pembrolizumab (an established immunotherapy) with chemotherapy — to shrink tumors before surgery in people with resectable non-small cell lung cancer. **You may be eligible if...** - You are 18–75 years old - You have confirmed non-squamous non-small cell lung cancer (NSCLC), stage IB through IIIB - You have not yet received any treatment for your lung cancer - You are able to undergo surgery **You may NOT be eligible if...** - You have previously received cancer treatment for your lung cancer - Your cancer has spread to the brain or other distant sites - You have serious autoimmune conditions or have had severe reactions to immunotherapy before - 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

DRUGPemetrexed

500 mg/m2 D1 IV Q3W

DRUGCisplatin

75 mg/m2 D1 IV Q3W

DRUGIBI363

1.5 mg/kg D1 IV Q3W

DRUGCarboplatin

AUC 5 mg/ml/min D1 IV Q3W

DRUGKeytruda

200mg D1 IV Q3W


Locations(1)

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, China

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NCT07122687