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

NCT06426511 | Recruiting Phase 2 DMC

• 1 other identifier: GASTO10112
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer, Nonsmall Cell

Outcome Measures

Primary Outcomes (1)

• The 2-year DFS rate of ctDNA-MRD guided consolidation toripalimab

  Determine if ctDNA-MRD guided consolidation toripalimab has a non-inferior 2-year DFS to direct 13 cycles of consolidation toripalimab therapy. 2-year DFS was defined as the proportion of patients who were disease free at 2 years.

  Baseline to 24 months

Secondary Outcomes (5)

• The 2-year OS rate of ctDNA-MRD guided consolidation toripalimab

  Baseline to 24 months

• The 2-year DFS in patients with persistently detectable ctDNA

  Baseline to 24 months

• Percentage of patients with undetectable ctDNA after consolidation toripalimab.

  Baseline to 15 months

• Percentage of patients with detectable ctDNA after adjuvant chemotherapy plus toripalimab.

  Baseline to 3 months

• Adverse Events

  Baseline to 36 months

Study Arms (2)

Observation for undetectable ctDNA after adjuvant therapy

EXPERIMENTAL

Observation follow-up for patients with undetectable ctDNA after 4 cycles of adjuvant chemotherapy plus toripalimab.

Drug: Toripalimab+Chemotherapy

Consolidation toripalimab for detectable ctDNA after adjuvant therapy

ACTIVE COMPARATOR

Consolidation toripalimab therapy for up to 13 cycles for patients with detectable ctDNA after 4 cycles of adjuvant chemotherapy plus toripalimab.

Drug: Toripalimab+Chemotherapy followed by consolidation toripalimab

Interventions

Toripalimab+Chemotherapy DRUG

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.

Observation for undetectable ctDNA after adjuvant therapy

Toripalimab+Chemotherapy followed by consolidation toripalimab DRUG

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.

Consolidation toripalimab for detectable ctDNA after adjuvant therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have undergone complete surgical resection (R0) of their stage IB , II and select IIIA NSCLC according to the AJCC 8th edition staging;
• Squamous or non-squamous NSCLC histology;
• Subjects should be without EGFR or ALK alterations for nonsquamous NSCLC;
• Male and female, aged 18-75 years;
• Surgery for lung cancer must be completed ≤ 60 days prior to study treatment;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level);
• Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN;
• Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min;
• Female subjects should not be pregnant or breast-feeding;
• Written informed consent provided. Being willing and able to comply with the visits, treatment plan, laboratory examinations and other study procedures scheduled in the study.

You may not qualify if:

• Not R0 resection, or metastatic disease.
• Subjects with known EGFR sensitive mutations or ALK translocation, EGFR and ALK mutation status needs to be identified for the subjects with non-squamous NSCLC;
• Previous treatment with systemic antitumor therapy for NSCLC;
• Severe allergic reaction to other monoclonal antibodies;
• Subjects with any known or suspected autoimmune disorder or immunodeficiency, with the following exceptions: hypothyroidism, hormone therapy is not needed, or well controlled at physiological dose; controlled type I diabetes;
• Uncontrolled active hepatitis B (defined as positive hepatitis B surface antigen in screening period with HBV-DNA detected higher than the upper limit of normal at the clinical laboratory of the study center); active hepatitis C (defined as positive hepatitis C surface antibody in screening period and positive HCV-RNA);
• Vaccination of live vaccine within 30 days prior to the first dose;
• Evidence of clinically active interstitial lung disease;
• Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);
• Inability to comply with protocol or study procedures;
• Any unstable systemic disease (including active infection, active tuberculosis uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease);
• A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study and may confuse the study results;
• History of another malignancy in the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
• Women who are pregnant or nursing.
• Ingredients mixed with small cell lung cancer patients.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Si-Yu Wang, MD

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Si-Yu Wang, MD

CONTACT

+86 20 87343439; wangsy@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Incorporate ctDNA-MRD to personalize the administration of consolidation toripalimab therapy for completely resected stage IB-IIIA NSCLC

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 23, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (1)