Clinical trial · Observational
A Real-world Study of Adjuvant Therapy in Early Stage NSCLC With EGFR Mutation-Positive in China
A Prospective, National, Multi-center, Non-intervention Real-world Study of Adjuvant Therapy in Early Stage NSCLC With EGFR Mutation-Positive in China
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a prospective, national, multi-center, non-interventional study. The main purpose is to explore the initial adjuvant treatment pattern after radical resection for early-stage NSCLC patients with EGFR Mutation-Positive in the real world. The secondary purpose was to observe the postoperative follow-up treatment pattern and its subgroups (based on different EGFR mutation status and different clinical stages).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC, Stage I | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| NSCLC, Stage II | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| NSCLC, Stage III | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgeries | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- The distribution of participants with initial adjuvant treatment pattern after radical resection surgery for early-stage NSCLC patients
- timeFrame
- 2 years
- description
- Descriptive summary statistics ( total number of cases, number of missing cases, frequency, and percentage of each category) were used to describe the distribution of participants with initial adjuvant treatment patterns, including chemical, targeted, combined, or other therapy. Set subgroup analysis for different initial adjuvant treatment pattern, including different clinical stages (according to phase I/ Phase II/ stage III) and different EGFR mutation status (19del or 21 L858R);
- measure
- Time on initial adjuvant treatment
- timeFrame
- 2 years
- description
- Calculate the time from the start date to the end of initial adjuvant treatment. The total number of cases, number of missing cases, mean, standard deviation, median, 25th and 75th percentiles, minimum and maximum were used for statistical description.
- measure
- The interval from the date of operation to the start date of initial adjuvant therapy with EGFR-TKI.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Informed consent signed; 2. Newly confirmed EGFR Mutation-Positive NSCLC confirmed by histopathology except for cytology; 3. Receiving or not receiving neoadjuvant treatment before surgery; 4. Patients with stage I-III NSCLC undergo confirmed radical R0 resection; Exclusion Criteria: 1. Patients who currently or have previously participated in any other anti-tumor clinical studies; 2. Patients with NSCLC who have received any systemic anti-cancer therapy as the main treatment in the past. Cytotoxic therapy, targeted therapy (tyrosine kinase inhibitors or monoclonal antibodies) and immunotherapy included except for the use of neoadjuvant therapy; 3. Patients who have received adjuvant therapy before enrollment. 4. Patients with stage I-III NSCLC whose surgical resection cannot be confirmed. 5. Patients assessed by the investigator as unfit for enrollment, such as neurological disorders or metabolic disorders, physical examination or laboratory examination suspected that the patient has a possible disease, or has contraindications to the use of study drugs, or has treatment-related complications High risk etc.
References
Publications (0)
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