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

Recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Third-generation EGFR-TKI; Drug: EGFR-TKI

• Registration Number: NCT04324164
• Lead Sponsor: Hunan Province Tumor Hospital

Brief Summary

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

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 Timeline

• Study Start: 2020-03-24
• Study First Submitted: 2020-03-25
• Study First Submitted QC: 2020-03-25
• Study First Posted: 2020-03-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27
• Primary Completion: 2025-12-24
• Study Completion: 2027-12-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1 Uncommon EGFR exon 19del	Third-generation EGFR-TKI	patients with uncommon EGFR exon 19del
Cohort 2 EGFR exon 19delins	Third-generation EGFR-TKI	patients with EGFR exon 19delins
Cohort 5 Rare Uncommon Point Mutations	EGFR-TKI	patients with rare uncommon point mutations
Cohort 4 Common Uncommon Point Mutations	EGFR-TKI	patients with common uncommon point mutations
Cohort 3 EGFR exon 18del	EGFR-TKI	patients with EGFR exon 18del
Cohort 6 Compound Mutations Uncommon With Uncommon	EGFR-TKI	patients with compound mutations uncommon with uncommon
Cohort 7 Compound Mutations Uncommon With Common	EGFR-TKI	patients with compound mutations uncommon with common

Primary Outcome Measures

Name	Time	Method
PFS	5 years	Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Yongchang Zhang; 🇨🇳 Changsha, Hunan, China