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

NCT04324164 | Recruiting

• 1 other identifier: SONICS
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)

  5 years

Secondary Outcomes (2)

• OS

  5 years

• ORR

  5 years

Study Arms (7)

Cohort 1 Uncommon EGFR exon 19del

patients with uncommon EGFR exon 19del

Drug: Third-generation EGFR-TKI

Cohort 2 EGFR exon 19delins

patients with EGFR exon 19delins

Drug: Third-generation EGFR-TKI

Cohort 3 EGFR exon 18del

patients with EGFR exon 18del

Drug: EGFR-TKI

Cohort 4 Common Uncommon Point Mutations

patients with common uncommon point mutations

Drug: EGFR-TKI

Cohort 5 Rare Uncommon Point Mutations

patients with rare uncommon point mutations

Drug: EGFR-TKI

Cohort 6 Compound Mutations Uncommon With Uncommon

patients with compound mutations uncommon with uncommon

Drug: EGFR-TKI

Cohort 7 Compound Mutations Uncommon With Common

patients with compound mutations uncommon with common

Drug: EGFR-TKI

Interventions

Third-generation EGFR-TKI DRUG

Third-generation EGFR-TKI including Osimertinib/Furmonertinib/Almonertinib, etc.

Cohort 1 Uncommon EGFR exon 19del; Cohort 2 EGFR exon 19delins

EGFR-TKI DRUG

All EGFR-TKI

Cohort 3 EGFR exon 18del; Cohort 4 Common Uncommon Point Mutations; Cohort 5 Rare Uncommon Point Mutations; Cohort 6 Compound Mutations Uncommon With Uncommon; Cohort 7 Compound Mutations Uncommon With Common

Eligibility Criteria

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

Study Population

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

You may qualify if:

• ，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology
• Uncommon EGFR Mutant Advanced NSCLC

You may not qualify if:

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

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

Study Sites (1)

Yongchang Zhang

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yongchang Zhang, MD

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongchang Zhang, MD

CONTACT

+8613873123436; zhangyongchang@csu.edu.cn

Nong Yang, MD

CONTACT

+8613055193557; yangnong0217@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: March 27, 2020
• Study Start: March 24, 2020
• Primary Completion: December 24, 2025
• Study Completion (Estimated): December 24, 2027
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

CN (1)