Real-World Outcomes of Resected EGFR-Mutated NSCLC Patients Treated With Adjuvant EGFR-TKI in China

NCT07593248 | Not Yet Recruiting

• 1 other identifier: D5164R00012
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multi-centre, observational study, with retrospective data collection and prospective active follow-up. The aim is to measure the treatment pattern and real-world outcomes of EGFR-TKI as an adjuvant therapy in patients with early-stage EGFR-mutated NSCLC. The study period ranges from July 1st, 2022 to June 30th, 2031. Approximately 2,000 patients will be enrolled from 15 sites in China.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• To assess the effectiveness in real world of EGFR-TKI adjuvant therapy in resected NSCLC as measured by 5-year OS rate

  OS is defined as the time from the first dose of EGFR-TKI adjuvant therapy until the date of death due to any cause. The analysis will include all patients received EGFR-TKI adjuvant therapy during the study. All deaths will be included, regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy. The primary measure of interest is the OS rate at 5 years

  from enrollment up to 5 years after treatment initiation

Secondary Outcomes (4)

• To assess the effectiveness in real world of EGFR-TKI adjuvant therapy in resected as measured by 2, 3, 4, 5-year DFS rate

  from enrollment up to 5 years after treatment initiation

• To assess the treatment duration and reason for discontinuation in real world of EGFR-TKI adjuvant therapy in resected NSCLC

  from enrollment up to 5 years after treatment initiation

• To assess the treatment duration and reason for discontinuation in real world of EGFR-TKI adjuvant therapy in resected NSCLC

  from enrollment up to 5 years after treatment initiation

• To assess the safety of EGFR-TKI used as an adjuvant， neoadjuvant therapy and used for post recurrence in resected NSCLC

  from enrollment up to 5 years after treatment initiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

stage IB to III NSCLC who have received adjuvant EGFR-TKI therapy.

You may qualify if:

• Diagnosed stage IB-III NSCLC on or prior to the index date;
• Initiated adjuvant EGFR-TKI from July 1st, 2023 to June 30th, 2026

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• YiLong Wu

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 30, 2031
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.