Gefitinib Long-term Survivor Study

Study identifier:D7913R00020

ClinicalTrials.gov identifier:NCT02932345

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

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

Medical condition

EGFR mutation positive advanced non-small-cell lung cancer

Phase

N/A

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

Study type

Observational

Age

N/A

Date

Study Start Date: 31 Oct 2016

Primary Completion Date: 04 Jul 2017

Study Completion Date: 04 Jul 2017

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -

Verification:

Verified 01 Dec 2021 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

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.

No locations available

Arms	Assigned Interventions
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	-

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Yilong WU

Guangdong General Hospital