Minimal Residual Disease Guiding Adjuvant Therapy in Stage I NSCLC

NCT06709274 | Not Yet Recruiting

• 1 other identifier: CTONG2301
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 15

Brief Summary

This investigator-initiated study aims to evaluate the effectiveness of minimal residual disease (MRD) as a biomarker for guiding adjuvant therapy decisions in patients with Stage I non-small-cell lung cancer (NSCLC). The study will compare outcomes between an MRD-guided management group and a standard-of-care group, focusing on whether the use of MRD information can improve the 3-year disease-free survival rate compared to existing treatment protocols. Participants in the MRD-guided management group will receive targeted therapy, immunotherapy, or observation based on their postoperative MRD status, while those in the standard-of-care group will receive treatments or observation according to current clinical guidelines.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 3-Year disease-free survival (DFS) Rate

  The proportion of patients remain disease-free at the 3-year mark starting from the day of randomization

  3 years post randomization

Secondary Outcomes (6)

• 5-Year disease-free survival (DFS) Rate

  5 years post randomization

• 5-Year overall survival (OS) rate

  5 years post randomization

• Disease-free survival (DFS)

  Up to 8 years post randomization

• Overall survival

  Up to 8 years post randomization

• Quality of Life (QoL) Assessed using the EORTC QLQ-C30 (Version 3.0)

  Up to 8 years post randomization

Study Arms (2)

MRD-guided management

EXPERIMENTAL

Patients who are MRD-positive after surgery in the MRD-guided management group receive adjuvant therapy. Patients who are MRD-negative in the MRD-guided management group are monitored through observation.

Drug: Osimertinib; Drug: Alectinib; Drug: TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy

Standard of care

NO INTERVENTION

Adjuvant therapy is not recommended. However, if the physician and patient decide on adjuvant therapy, the treatment regimen and cycle must be documented. Researchers are strongly advised to follow the medication guidelines laid out in the Chinese Society of Clinical Oncology (CSCO) Clinical Practice Guidelines.

Interventions

Osimertinib DRUG

80mg daily, for EGFR-positive patients

MRD-guided management

Alectinib DRUG

600mg BID, for ALK-rearranged patients

MRD-guided management

TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy DRUG

Toripalimab 240mg + Platinum-based chemotherapy (Q3W for 4 cycles), followed by Toripalimab maintenance therapy (240mg Q3W for one year), for EGFR/ALK wildtype patients

MRD-guided management

Eligibility Criteria

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

You may qualify if:

• Non-small cell lung cancer (NSCLC) confirmed by histological and/or cytological examination. Invasive subtypes are required for adenocarcinomas.
• Stage IA or IB after surgery based on pathological TNM8 staging criteria established by the International Union Against Cancer/American Joint Committee on Cancer (8th Edition).
• Completely surgical resection (R0) of the primary NSCLC via lobectomy, segmentectomy, or sleeve lobectomy. The gross tumor must be entirely removed, and all surgical margins of the excised tumor must be negative.
• Complete recovery from surgery with no evidence of disease progression within 2 weeks prior to the first treatment decision.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• Minimum life expectancy of ≥12 weeks.
• Demonstrate adequate organ function, including:
• Hematological parameters:
• Absolute neutrophil count ≥1.5×10\^9/L
• Platelet count ≥100×10\^9/L
• Hemoglobin ≥90 g/L
• Liver function:
• ALT ≤2.5× upper limit of normal (ULN)
• AST ≤2.5×ULN
• Total Bilirubin (TBL) ≤1.5×ULN Renal function: Creatinine level ≤1.25×ULN, or creatinine clearance ≥60 mL/min (measured or calculated using the Cockcroft-Gault formula).

You may not qualify if:

• Histopathologically confirmed small cell carcinoma components.
• Presence of multiple pulmonary nodules.
• Incomplete resections (R1/R2) or resections via bilateral lobectomy, pneumonectomy, or wedge resection.
• A history of any systemic anti-tumor treatment, including but not limited to surgery, neoadjuvant chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
• Significant allergies to any targeted drugs, immunotherapies, or chemotherapy agents used in the study.
• Previous use of any traditional Chinese medicine with anti-tumor properties, or use of such medicine within 2 weeks prior to surgery.
• History of other malignancies within the past 5 years, with the exception of the following:
• Other malignancies fully cured by surgery with a disease-free survival of more than 10 years
• Curable basal cell carcinoma of the skin
• Bladder carcinoma in situ
• Cervical carcinoma in situ
• History of interstitial lung disease, drug-induced interstitial lung disease, radiation-induced pneumonia requiring steroid treatment, or any evidence of clinically active interstitial lung disease.
• Active hepatitis B, defined as HBsAg positive with an HBV-DNA copy number exceeding the ULN established by the study center, accompanied by abnormal liver function, or requiring treatment as evaluated by the investigator.
• Presence of any unstable systemic disease, including but not limited to active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the past 3 months, serious arrhythmias that requires medication, liver disease, kidney disease, or metabolic disorders.
• Evidence of any other diseases, neurological or metabolic disorders, or physical exam or laboratory findings that may suggest contraindications for the investigational drug, or a high risk for treatment-related complications.

Sponsors & Collaborators

• Guangdong Association of Clinical Trials: lead
• Nanjing Geneseeq Technology Inc.: collaborator

Study Sites (15)

Dongguan People's Hospital

Dongguan, Guangdong, China

Location

The First People's Hospital of Foshan

Foshan, Guangdong, China

Location

Guangdong Provincial People's Hostpital

Guangzhou, Guangdong, China

Location

ZhuJiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Location

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Location

The Second Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Location

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

Location

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, China

Location

Hunan Cancer Hospital

Changsha, Hunan, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Location

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Location

The Third People's Hospital of Chengdu

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

osimertinib; alectinib; toripalimab; Drug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Yi-Long Wu, M.D.

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Xue-Ning Yang, M.D.

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xue-Ning Yang, M.D.

CONTACT

020-83827812; yangxuening@gdph.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2032
• Last Updated: November 29, 2024

Record last verified: 2024-11

Locations

CN (15)