Survival Outcome of EGFR-TKI in Uncommon EGFR Mutant Advanced NSCLC

January 23, 2025 updated by: Yongchang Zhang, Hunan Province Tumor Hospital

Survival Outcome of EGFR-TKI in Uncommon EGFR Mutant Advanced Non-small Cell Lung Cancer in China

This study aims to explore Survival Outcome of EGFR-TKI in Uncommon EGFR Mutant Advanced Non-small Cell Lung Cancer in China

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

inclusion criteria Uncommon EGFR Mutant Advanced Non-small Cell Lung Cancer EGFR G719X, exon 20 insert mutation without any anti-cancer treatment history

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Yongchang Zhang
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Uncommon EGFR Mutant Advanced Non-small Cell Lung Cancer in China

Description

Inclusion Criteria:

  • 18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology

    • Uncommon EGFR Mutant Advanced NSCLC

Exclusion Criteria:

  • Patients with contraindication of chemotherapy
  • Pregnant or breast feeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1 Uncommon EGFR exon 19del
patients with uncommon EGFR exon 19del
Drug: Third-generation EGFR-TKI
Third-generation EGFR-TKI including Osimertinib/Furmonertinib/Almonertinib, etc.
Cohort 2 EGFR exon 19delins
patients with EGFR exon 19delins
Drug: Third-generation EGFR-TKI
Third-generation EGFR-TKI including Osimertinib/Furmonertinib/Almonertinib, etc.
Cohort 3 EGFR exon 18del
patients with EGFR exon 18del
Drug: EGFR-TKI
All EGFR-TKI
Cohort 4 Common Uncommon Point Mutations
patients with common uncommon point mutations
Drug: EGFR-TKI
All EGFR-TKI
Cohort 5 Rare Uncommon Point Mutations
patients with rare uncommon point mutations
Drug: EGFR-TKI
All EGFR-TKI
Cohort 6 Compound Mutations Uncommon With Uncommon
patients with compound mutations uncommon with uncommon
Drug: EGFR-TKI
All EGFR-TKI
Cohort 7 Compound Mutations Uncommon With Common
patients with compound mutations uncommon with common
Drug: EGFR-TKI
All EGFR-TKI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 5 years
Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 5 years
Defined as the time from the start of treatment to the death of the subject due to any cause.
5 years
ORR
Time Frame: 5 years
Defined as the proportion of subjects achieving a complete remission (CR) or partial remission (PR) among all subjects.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hunan Province Tumor Hospital

Investigators

  • Principal Investigator: Yongchang Zhang, MD, Hunan Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2020

Primary Completion (Estimated)

December 24, 2025

Study Completion (Estimated)

December 24, 2027

Study Registration Dates

First Submitted

March 25, 2020

First Submitted That Met QC Criteria

March 25, 2020

First Posted (Actual)

March 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 23, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SONICS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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