Gefitinib Long-term Survivor Study

Terminated

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

• Registration Number: NCT02932345
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2016-10-11
• Study First Posted: 2016-10-13
• Study Start: 2016-10-31
• Primary Completion: 2017-07-04
• Study Completion: 2017-07-04
• Status Verified: 2021-12
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
EGFR mutation status	at time of Gefitinib treatment initiation, up to 10 years before study start
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
Histological subtype	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
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
Progression Free Survival (PFS)	from Gefitinib treatment initiation to disease progression or study completion, whichever occurred first, up to 12 years
Cancer type and date of first ever cancer diagnosis	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
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
Gefitinib treatment patterns- Starting dose	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
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
Overval survival (OS)	from Gefitinib treatment initiation to death or study completion, whichever occurred first, up to 12 years

Trial Locations

Locations (1)

Research Site; 🇨🇳 Hangzhou, Zhejiang, China