NCT04830826|Completed

A Real-world Study of Adjuvant Therapy in Early Stage NSCLC With EGFR Mutation-Positive in China

ADDRESS

A Prospective, National, Multi-center, Non-intervention Real-world Study of Adjuvant Therapy in Early Stage NSCLC With EGFR Mutation-Positive in China

The First Affiliated Hospital of Guangzhou Medical University ClinicalTrials.gov

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1 other identifier

D7913C00727

Study Type

observational

Target

1,490

Locations

1 country

Sites

Timeline

RegisteredApr 2021

StartedJul 2020

CompletionApr 2025

Brief Summary

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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,490

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jul 2020

Longer than P75 for all trials

Geographic Reach

1 country

51 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.7 years study duration

Study Start

First participant enrolled

July 9, 2020

Completed

9 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2021

Completed

12 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2024

Completed

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2025

Completed

Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

4 years

First QC Date

March 24, 2021

Last Update Submit

July 28, 2025

Conditions

NSCLC, Stage I NSCLC, Stage II NSCLC, Stage III

Keywords

EGFR MutationNSCLCAdjuvant Therapy

Outcome Measures

Primary Outcomes (4)

The distribution of participants with initial adjuvant treatment pattern after radical resection surgery for early-stage NSCLC patients
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);
2 years
Time on initial adjuvant treatment
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.
2 years
The interval from the date of operation to the start date of initial adjuvant therapy with EGFR-TKI.
Calculate the interval of operation to the adjuvant therapy with EGFR-TKI, which is classified into single-drug therapy and combined therapy. 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.
2 years
Numbers of therapy cycles of initial adjuvant treatment
The patients with chemotherapy were mainly calculated, divided into chemotherapy and targeted combination chemotherapy. The total number of chemotherapy cycles, the number of missing cases, the mean, standard deviation, the median, the 25th and 75th percentiles, the minimum and the maximum were statistically described
2 years

Secondary Outcomes (4)

The distribution of participants with follow-up treatment pattern after initial adjuvant treatment.
2 years
Time on follow-up treatment
2 years
The interval from the date of operation to the start date of the follow-up treatment with EGFR-TKI.
2 years
Numbers of therapy cycles of follow-up treatment
2 years

Interventions

SurgeriesPROCEDURE

Surgeries

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Continuously enroll all patients with early-stage (stage I-III), histopathologically confirmed, and EGFR mutation-positive NSCLC after R0 resection

You may qualify if:

Informed consent signed;
Newly confirmed EGFR Mutation-Positive NSCLC confirmed by histopathology except for cytology;
Receiving or not receiving neoadjuvant treatment before surgery;
Patients with stage I-III NSCLC undergo confirmed radical R0 resection;

You may not qualify if:

Patients who currently or have previously participated in any other anti-tumor clinical studies;
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;
Patients who have received adjuvant therapy before enrollment.
Patients with stage I-III NSCLC whose surgical resection cannot be confirmed.
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.

Contact the study team to confirm eligibility.