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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
342
80mg daily, for EGFR-positive patients
600mg BID, for ALK-rearranged patients
Toripalimab 240mg + Platinum-based chemotherapy (Q3W for 4 cycles), followed by Toripalimab maintenance therapy (240mg Q3W for one year), for EGFR/ALK wildtype patients
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
...and 5 more locations
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
Time frame: 3 years post randomization
5-Year disease-free survival (DFS) Rate
The proportion of patients remain disease-free at the 5-year mark starting from the day of randomization
Time frame: 5 years post randomization
5-Year overall survival (OS) rate
The proportion of patients remain alive at the 5-year mark starting from the day of randomization
Time frame: 5 years post randomization
Disease-free survival (DFS)
Defined as the time from randomization to the first recorded instance of tumor recurrence or metastasis, whichever occurs first
Time frame: Up to 8 years post randomization
Overall survival
Defined as the time from the day of randomization to death from any cause
Time frame: Up to 8 years post randomization
Quality of Life (QoL) Assessed using the EORTC QLQ-C30 (Version 3.0)
Assessed using the EORTC QLQ-C30 (Version 3.0), developed by the European Organization for Research and Treatment of Cancer. EORTC QLQ-C30 (Version 3.0) is utilized to assess the overall quality of life in cancer patients. It measures a global health status/QoL scale, five functional scales, three symptom scales, and six single items. Each dimension is scored on a scale from 0 to 100, where a high score for the global health status/QoL represents a high QoL, a high score for a functional scale represents a high/healthy level of functioning, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Time frame: Up to 8 years post randomization
Quality of Life (QoL) Assessed using the EORTC QLQ-LC13
Assessed using the EORTC QLQ-LC13, developed by the European Organization for Research and Treatment of Cancer. EORTC QLQ-LC13 is a supplementary module focusing specifically on the quality of life of patients with lung cancer. It provides additional insights into symptoms and problems related to lung cancer and its treatment. Like the QLQ-C30, responses are measured on a scale from 0 to 100, where higher scores indicate greater severity of symptoms
Time frame: Up to 8 years post randomization
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