Gefitinib Long-term Survivor Study

A Study of Clinical and Genomic Analysis on Long-term Survivors of EGFR Mutation Positive Advanced Non-small-cell Lung Cancer Patients With Gefitinib Treatment in China

The primary objective is to describe the genomic profile of long-term survivors, especially to find out potential genomic prognosis and/or predictive factors for gefitinib long-term efficacy as compared to rapid PD patients

Study Overview

• Status: Terminated
• Conditions: EGFR Mutation Positive Advanced Non-small-cell Lung Cancer

• Study Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Research Site
  • Fujian
    • Fuzhou, Fujian, China
      • Research Site
  • Guangdong
    • Guangzhou, Guangdong, China
      • Research Site
  • He Nan
    • Zhengzhou, He Nan, China
      • Research Site
  • Hebei
    • Shijiazhuang, Hebei, China
      • Research Site
  • Hubei
    • Wuhan, Hubei, China
      • Research Site
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Research Site
  • Jilin
    • Changchun, Jilin, China
      • Research Site
  • Liaoning
    • Shenyang, Liaoning, China
      • Research Site
  • Shaanxi
    • XI An, Shaanxi, China
      • Research Site
  • Shanghai
    • Shanghai, Shanghai, China
      • Research Site
  • Shanxi
    • Taiyuan, Shanxi, China
      • Research Site
  • Sichuan
    • Chengdu, Sichuan, China
      • Research Site
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study will recruit approximately 150 aNSCLC patients who fulfil the inclusion/exclusion criteria

Description

Inclusion Criteria:

For inclusion in the long-term survivors group, the study subjects must fulfil the following criteria at the time of screening:

1. Provision of informed consent or EC approve informed consent waiver prior to any study specific procedures
2. Histological or cytological confirmed locally advanced NSCLC (stage III B) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy
3. EGFR mutation positive
4. Patients who continuously received gefitinib for at least 3 years without evidence of PD
5. Patients with OS ≥ 5 years from NSCLC diagnosis will be preferred
6. Collect archival tumour tissue before gefitinib treatment (blood and re-biopsy tumour tissue are optional); tumor tissue samples requirements: 1) slices requirements: >1 cm2, thickness 4-5 μm, ≥ 15 slices. or, whole FFPE block; 2) tumor percentage > 20% and necrosis < 30% by pathology QC.

For inclusion in the rapid PD group, the study subjects must fulfil the following criteria:

1. Provision of informed consent or EC approve informed consent waiver prior to any study specific procedures
2. Histological or cytological confirmed locally advanced NSCLC (stage III B) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy
3. EGFR mutation positive
4. Patients who had undergone PD after gefitinib treatment≤3 months (Rapid PD)
5. Collect archival tumour tissue before gefitinib treatment (blood and re-biopsy tumour tissue samples are optional) ; tumor tissue samples requirements: 1) slices requirements: >1 cm2, thickness 4-5 μm, ≥ 15 slices. or, whole FFPE block; 2) tumor percentage > 20% and necrosis < 30% by pathology QC.

Exclusion Criteria:

For the active patients, who must not enter the study if any of the following exclusion criteria are fulfilled 1. Patients who disagree to participate this study.

For the terminated patients, who must not enter the study if any of the following exclusion criteria are fulfilled

1. Patients in whose medical objection was recorded to use the existing data from medical practice for scientific research.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Long-term survivors group (case); EGFR M+ aNSCLC patients who continuously received gefitinib for at least 3 years
Rapid PD group (control); EGFR M+ aNSCLC patients who had undergone PD after gefitinib treatment≤3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with specific genomic alterations(mutation, copy number change and fusion) of short or long-term survivors	at time of sample collection before Gefitinib treatment initiation, up to 10 years before study start

Secondary Outcome Measures

Outcome Measure	Time Frame
Sex	at time of Gefitinib treatment initiation,up to 10 years before study start
Age	at time of Gefitinib treatment initiation, up to 10 years before study start
Pre-existing comorbidities at initiation of gefitinib therapy	at time of Gefitinib treatment initiation, up to 10 years before study start
Cancer type and date of first ever cancer diagnosis	at time of Gefitinib treatment initiation, up to 10 years before study start
Histological subtype	at time of Gefitinib treatment initiation, up to 10 years before study start
Location(s) of metastatic disease at initiation of gefitinib therapy for subjects with TNM stage IV disease	at time of Gefitinib treatment initiation, up to 10 years before study start
EGFR mutation status	at time of Gefitinib treatment initiation, up to 10 years before study start
Smoking status	at time of Gefitinib treatment initiation, up to 10 years before study start
ECOG performance status at time of Gefitinib treatment initiation	at time of Gefitinib treatment initiation, up to 10 years before study start
Gefitinib treatment patterns- Starting dose	at time of Gefitinib treatment initiation, up to 10 years before study start
Gefitinib treatment patterns- Dose reductions, treatment interruptions, discontinuation including reasons	from Gefitinib treatment initiation to Gefitinib treatment discontinuation or study completion, whichever occurred first, up to 12 years
Gefitinib treatment patterns- Types of other systemic therapies given in combination with gefitinib	from Gefitinib treatment initiation to Gefitinib treatment discontinuation or study completion, whichever occurred first, up to 12 years
Therapeutic agent name post-gefitinib discontinuation	from gefitinib discontinuation to one year post- gefitinib discontinuation, around one year
Documented tumour response (complete or partial response or stable disease, according to RECIST) as determined by the treating physician by clinical judgment and/or imaging after first ever initiation of gefitinib	from Gefitinib treatment initiation to study completion, up to 12 years
Progression Free Survival (PFS)	from Gefitinib treatment initiation to disease progression or study completion, whichever occurred first, up to 12 years
Overval survival (OS)	from Gefitinib treatment initiation to death or study completion, whichever occurred first, up to 12 years

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2016
• Primary Completion (Actual): July 4, 2017
• Study Completion (Actual): July 4, 2017

Study Registration Dates

• First Submitted: September 12, 2016
• First Submitted That Met QC Criteria: October 11, 2016
• First Posted (Estimate): October 13, 2016

Study Record Updates

• Last Update Posted (Actual): March 24, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: EGFR mutation; non-small-cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: D7913R00020