RecruitingPhase 2NCT06426511

ctDNA-MRD Guided Consolidation Toripalimab in Stage IB-IIIA NSCLC

Consolidation Toripalimab Therapy Guided by Circulating Tumor DNA (ctDNA)-Minimal Residual Disease (MRD) for Completely Resected Stage IB-IIIA Non-small-cell Lung Cancer (Without EGFR or ALK Alterations for Nonsquamous Lung Cancer)

Sponsor

Sun Yat-sen University

Enrollment

80 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Lung Cancer, Nonsmall Cell

Summary

This study aims to incorporate circulating tumor DNA (ctDNA)-minimal residual disease (MRD) to personalize the administration of consolidation toripalimab therapy in resected stage IB-IIIA non-small-cell lung cancer (NSCLC) after adjuvant therapy. Toripalimab is a humanized monoclonal antibody for human programmed cell death protein 1. Toripalimab was approved as a consolidation treatment after perioperative therapy in combination with chemotherapy for resectable stage III NSCLC.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using a blood test for traces of cancer DNA (called ctDNA/MRD) to guide consolidation immunotherapy (toripalimab) after surgery can help prevent lung cancer from coming back in patients with early-to-mid stage NSCLC. **You may be eligible if...** - You are between 18 and 75 years old - You have had a complete surgical removal (R0) of Stage IB, II, or select Stage IIIA NSCLC within the past 60 days - Your tumor does not have EGFR or ALK mutations (for non-squamous tumors) - Your blood counts and organ function meet study requirements - You are in good overall health (ECOG 0–1) **You may NOT be eligible if...** - Surgery did not fully remove the cancer - You have known EGFR or ALK mutations - You have previously received systemic treatment for lung cancer - You have a severe allergy to monoclonal antibody medications - 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

DRUGToripalimab+Chemotherapy

After surgical resection, patients received 4 cycle of toripalimab (240 mg) in combination with platinum-based adjuvant treatment. Administration of standard postoperative adjuvant chemotherapy for stage IB disease was not mandatory; decisions about whether patients with IB disease would receive adjuvant chemotherapy were made by the physicians.

DRUGToripalimab+Chemotherapy followed by consolidation toripalimab

After surgical resection, patients received 4 cycle of toripalimab (240 mg) in combination with platinum-based adjuvant treatment, and then maintenance treatment with single-agent toripalimab (240 mg) once every 3 weeks for up to 13 cycles. Administration of standard postoperative adjuvant chemotherapy for stage IB disease was not mandatory; decisions about whether patients with IB disease would receive adjuvant chemotherapy were made by the physicians.