Clinical trial NCT02932345: Gefitinib Long-term Survivor Study
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: EGFR Mutation Positive Advanced Non-small-cell Lung Cancer
Keywords: EGFR mutation; non-small-cell lung cancer;
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2016-10-13
Enrollment: 59
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will recruit approximately 150 aNSCLC patients who fulfil the inclusion/exclusion criteria

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


Eligibility 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.

Primary outcomes:
measure: Proportion of patients with specific genomic alterations(mutation, copy number change and fusion) of short or long-term survivors
timeFrame: at time of sample collection before Gefitinib treatment initiation, up to 10 years before study start
Secondary outcomes:
measure: Sex
timeFrame: at time of Gefitinib treatment initiation,up to 10 years before study start
measure: Age
timeFrame: at time of Gefitinib treatment initiation, up to 10 years before study start
measure: Pre-existing comorbidities at initiation of gefitinib therapy
timeFrame: at time of Gefitinib treatment initiation, up to 10 years before study start
measure: Cancer type and date of first ever cancer diagnosis
timeFrame: at time of Gefitinib treatment initiation, up to 10 years before study start
measure: Histological subtype
timeFrame: at time of Gefitinib treatment initiation, up to 10 years before study start
measure: Location(s) of metastatic disease at initiation of gefitinib therapy for subjects with TNM stage IV disease
timeFrame: at time of Gefitinib treatment initiation, up to 10 years before study start
measure: EGFR mutation status
timeFrame: at time of Gefitinib treatment initiation, up to 10 years before study start
measure: Smoking status
timeFrame: at time of Gefitinib treatment initiation, up to 10 years before study start
measure: ECOG performance status at time of Gefitinib treatment initiation
timeFrame: at time of Gefitinib treatment initiation, up to 10 years before study start
measure: Gefitinib treatment patterns- Starting dose
timeFrame: at time of Gefitinib treatment initiation, up to 10 years before study start
measure: Gefitinib treatment patterns- Dose reductions, treatment interruptions, discontinuation including reasons
timeFrame: from Gefitinib treatment initiation to Gefitinib treatment discontinuation or study completion, whichever occurred first, up to 12 years
measure: Gefitinib treatment patterns- Types of other systemic therapies given in combination with gefitinib
timeFrame: from Gefitinib treatment initiation to Gefitinib treatment discontinuation or study completion, whichever occurred first, up to 12 years
measure: Therapeutic agent name post-gefitinib discontinuation
timeFrame: from gefitinib discontinuation to one year post- gefitinib discontinuation, around one year
measure: 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
timeFrame: from Gefitinib treatment initiation to study completion, up to 12 years
measure: Progression Free Survival (PFS)
timeFrame: from Gefitinib treatment initiation to disease progression or study completion, whichever occurred first, up to 12 years
measure: Overval survival (OS)
timeFrame: from Gefitinib treatment initiation to death or study completion, whichever occurred first, up to 12 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Fuzhou
country: China
facility: Research Site
state: Fujian
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Zhengzhou
country: China
facility: Research Site
state: He Nan
city: Shijiazhuang
country: China
facility: Research Site
state: Hebei
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Changchun
country: China
facility: Research Site
state: Jilin
city: Shenyang
country: China
facility: Research Site
state: Liaoning
city: XI An
country: China
facility: Research Site
state: Shaanxi
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Taiyuan
country: China
facility: Research Site
state: Shanxi
city: Chengdu
country: China
facility: Research Site
state: Sichuan
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Yilong WU, Professor
role: PRINCIPAL_INVESTIGATOR
References: