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A prospective, multicenter trial of adjuvant therapy in high-risk stage I NSCLC patients after tumor radical resection

A prospective, multicenter trial of adjuvant therapy in high-risk stage I NSCLC patients after tumor radical resection

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400079461
Enrollment
Unknown
Registered
2024-01-03
Start date
2023-05-08
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

Grouping based on different adjuvant therapy methods:None

Sponsors

The First Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Obtain the patient's written informed consent; (2) Male or female, age=18 years old; (3) The pathological stage is stage I NSCLC, and the primary tumor lesion is completely removed by surgery; (4) Contains at least one high-risk factor for recurrence (pathology: low-differentiated tumor/vascular invasion/visceral pleural invasion/pathological subtype with micronipple or solid components/air cavity spread; detection: blood MRD positive 1 month after surgery); (5) EGFR sensitive mutation is positive (19del and/or L858R mutation, with or without T790M mutation), and must be confirmed by tumor tissue analysis.

Exclusion criteria

Exclusion criteria: (1) Patients who have participated in any other anti-tumor clinical research at present or in the past; (2) Any previous NSCLC treatment with systemic anti-cancer therapy as the main treatment method, including cytotoxic therapy, targeted therapy (including tyrosine kinase inhibitors or monoclonal antibodies) and immunotherapy; (3) Patients who received adjuvant treatment before joining the group; (4) The researchers evaluate patients who are not suitable for the group, such as neurological disorders or metabolic disorders, physical examinations or laboratory tests suspected to have possible diseases, or contraindications to the use of research drugs, or high risk of treatment-related complications, etc.; (5) Have a history of other malignant tumors, or have now combined with other malignant tumors (except for malignant tumors that have been radically treated and have not recured for 5 years after surgery, such as cervical cancer in situ, skin basal cell carcinoma and thyroid papillary carcinoma, etc.).

Design outcomes

Primary

MeasureTime frame
Median disease-free survival;

Secondary

MeasureTime frame
Median survival;2/3/5-year disease-free survival;2/3/5-year overall survival;Safety;

Countries

China

Contacts

Public ContactWei Liu

The First Hospital of Jilin University

l_w01@jlu.edu.cn+86 135 9608 3366

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026