Minimal Residual Disease Guiding Adjuvant Therapy in Stage I NSCLC
NCT ID: NCT06709274
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
342 participants
INTERVENTIONAL
2024-11-30
2032-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MRD-guided management
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.
Osimertinib
80mg daily, for EGFR-positive patients
Alectinib
600mg BID, for ALK-rearranged patients
TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy
Toripalimab 240mg + Platinum-based chemotherapy (Q3W for 4 cycles), followed by Toripalimab maintenance therapy (240mg Q3W for one year), for EGFR/ALK wildtype patients
Standard of care
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.
No interventions assigned to this group
Interventions
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Osimertinib
80mg daily, for EGFR-positive patients
Alectinib
600mg BID, for ALK-rearranged patients
TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy
Toripalimab 240mg + Platinum-based chemotherapy (Q3W for 4 cycles), followed by Toripalimab maintenance therapy (240mg Q3W for one year), for EGFR/ALK wildtype patients
Eligibility Criteria
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Inclusion Criteria
2. 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).
3. 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.
4. Complete recovery from surgery with no evidence of disease progression within 2 weeks prior to the first treatment decision.
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
6. Minimum life expectancy of ≥12 weeks.
7. 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).
8. Male or female, age between 18 and 75 years.
9. Written informed consent must be obtained from the subject or their legal representative.
10. Participants regardless of sex must agree to use effective contraception during the study period and for 3 months following treatment completion.
11. Willingness and ability to comply with visit schedules, treatment plans, and laboratory assessments.
Exclusion Criteria
2. Presence of multiple pulmonary nodules.
3. Incomplete resections (R1/R2) or resections via bilateral lobectomy, pneumonectomy, or wedge resection.
4. A history of any systemic anti-tumor treatment, including but not limited to surgery, neoadjuvant chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
5. Significant allergies to any targeted drugs, immunotherapies, or chemotherapy agents used in the study.
6. Previous use of any traditional Chinese medicine with anti-tumor properties, or use of such medicine within 2 weeks prior to surgery.
7. 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
8. 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.
9. 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.
10. 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.
11. 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.
12. Any of the following cardiac conditions:
* Resting ECG QT interval (QTc) \> 470 msec.
* Significant abnormalities in rhythm, conduction, or morphology on resting ECG, including complete left bundle branch block, third-degree atrioventricular block, or second-degree atrioventricular block
* Factors increasing the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death in a first-degree relative under the age of 40, or use of medications known to prolong QT interval.
13. Blood transfusion within 2 weeks prior to and during the surgery.
14. History of alcohol or drug abuse.
15. Pregnant or breastfeeding females.
16. Any other factors that the investigator deems may affect the progress of the study or compromise the trial data
18 Years
75 Years
ALL
No
Sponsors
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Nanjing Geneseeq Technology Inc.
INDUSTRY
Guangdong Association of Clinical Trials
OTHER
Responsible Party
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Xue-Ning Yang
Principal Investigator
Principal Investigators
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Yi-Long Wu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial People's Hospital
Xue-Ning Yang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial People's Hospital
Locations
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Dongguan People's Hospital
Dongguan, Guangdong, China
The First People's Hospital of Foshan
Foshan, Guangdong, China
Guangdong Provincial People's Hostpital
Guangzhou, Guangdong, China
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
The Third People's Hospital of Chengdu
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CTONG2301
Identifier Type: -
Identifier Source: org_study_id