EGFR Mutation Positive Advanced Non-small-cell Lung Cancer Clinical Trial
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
| NCT number | NCT02932345 |
| Other study ID # | D7913R00020 |
| Secondary ID | |
| Status | Terminated |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 31, 2016 |
| Est. completion date | July 4, 2017 |
| Verified date | December 2021 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Terminated |
| Enrollment | 59 |
| Est. completion date | July 4, 2017 |
| Est. primary completion date | July 4, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Research Site | Beijing | Beijing |
| China | Research Site | Changchun | Jilin |
| China | Research Site | Chengdu | Sichuan |
| China | Research Site | Fuzhou | Fujian |
| China | Research Site | Guangzhou | Guangdong |
| China | Research Site | Hangzhou | Zhejiang |
| China | Research Site | Nanjing | Jiangsu |
| China | Research Site | Shanghai | Shanghai |
| China | Research Site | Shenyang | Liaoning |
| China | Research Site | Shijiazhuang | Hebei |
| China | Research Site | Taiyuan | Shanxi |
| China | Research Site | Wuhan | Hubei |
| China | Research Site | XI An | Shaanxi |
| China | Research Site | Zhengzhou | He Nan |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Sex | at time of Gefitinib treatment initiation,up to 10 years before study start | ||
| Secondary | Age | at time of Gefitinib treatment initiation, up to 10 years before study start | ||
| Secondary | Pre-existing comorbidities at initiation of gefitinib therapy | at time of Gefitinib treatment initiation, up to 10 years before study start | ||
| Secondary | Cancer type and date of first ever cancer diagnosis | at time of Gefitinib treatment initiation, up to 10 years before study start | ||
| Secondary | Histological subtype | at time of Gefitinib treatment initiation, up to 10 years before study start | ||
| Secondary | 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 | ||
| Secondary | EGFR mutation status | at time of Gefitinib treatment initiation, up to 10 years before study start | ||
| Secondary | Smoking status | at time of Gefitinib treatment initiation, up to 10 years before study start | ||
| Secondary | ECOG performance status at time of Gefitinib treatment initiation | at time of Gefitinib treatment initiation, up to 10 years before study start | ||
| Secondary | Gefitinib treatment patterns- Starting dose | at time of Gefitinib treatment initiation, up to 10 years before study start | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | Therapeutic agent name post-gefitinib discontinuation | from gefitinib discontinuation to one year post- gefitinib discontinuation, around one year | ||
| Secondary | 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 | ||
| Secondary | Progression Free Survival (PFS) | from Gefitinib treatment initiation to disease progression or study completion, whichever occurred first, up to 12 years | ||
| Secondary | Overval survival (OS) | from Gefitinib treatment initiation to death or study completion, whichever occurred first, up to 12 years |