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Gefitinib Long-term Survivor Study

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ClinicalTrials.gov Identifier: NCT02932345
Recruitment Status : Completed
First Posted : October 13, 2016
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease
EGFR Mutation Positive Advanced Non-small-cell Lung Cancer

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Study Type : Observational
Actual Enrollment : 59 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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
Actual Study Start Date : October 31, 2016
Actual Primary Completion Date : July 4, 2017
Actual Study Completion Date : July 4, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Gefitinib

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



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

Secondary Outcome Measures :
  1. Sex [ Time Frame: at time of Gefitinib treatment initiation,up to 10 years before study start ]
  2. Age [ Time Frame: at time of Gefitinib treatment initiation, up to 10 years before study start ]
  3. Pre-existing comorbidities at initiation of gefitinib therapy [ Time Frame: at time of Gefitinib treatment initiation, up to 10 years before study start ]
  4. Cancer type and date of first ever cancer diagnosis [ Time Frame: at time of Gefitinib treatment initiation, up to 10 years before study start ]
  5. Histological subtype [ Time Frame: at time of Gefitinib treatment initiation, up to 10 years before study start ]
  6. Location(s) of metastatic disease at initiation of gefitinib therapy for subjects with TNM stage IV disease [ Time Frame: at time of Gefitinib treatment initiation, up to 10 years before study start ]
  7. EGFR mutation status [ Time Frame: at time of Gefitinib treatment initiation, up to 10 years before study start ]
  8. Smoking status [ Time Frame: at time of Gefitinib treatment initiation, up to 10 years before study start ]
  9. ECOG performance status at time of Gefitinib treatment initiation [ Time Frame: at time of Gefitinib treatment initiation, up to 10 years before study start ]
  10. Gefitinib treatment patterns- Starting dose [ Time Frame: at time of Gefitinib treatment initiation, up to 10 years before study start ]
  11. Gefitinib treatment patterns- Dose reductions, treatment interruptions, discontinuation including reasons [ Time Frame: from Gefitinib treatment initiation to Gefitinib treatment discontinuation or study completion, whichever occurred first, up to 12 years ]
  12. Gefitinib treatment patterns- Types of other systemic therapies given in combination with gefitinib [ Time Frame: from Gefitinib treatment initiation to Gefitinib treatment discontinuation or study completion, whichever occurred first, up to 12 years ]
  13. Therapeutic agent name post-gefitinib discontinuation [ Time Frame: from gefitinib discontinuation to one year post- gefitinib discontinuation, around one year ]
  14. 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 [ Time Frame: from Gefitinib treatment initiation to study completion, up to 12 years ]
  15. Progression Free Survival (PFS) [ Time Frame: from Gefitinib treatment initiation to disease progression or study completion, whichever occurred first, up to 12 years ]
  16. Overval survival (OS) [ Time Frame: from Gefitinib treatment initiation to death or study completion, whichever occurred first, up to 12 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will recruit approximately 150 aNSCLC patients who fulfil the inclusion/exclusion criteria
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02932345


Locations
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China, Beijing
Research Site
Beijing, Beijing, China
China, Fujian
Research Site
Fuzhou, Fujian, China
China, Guangdong
Research Site
Guangzhou, Guangdong, China
China, He nan
Research Site
Zhengzhou, He nan, China
China, Hebei
Research Site
Shijiazhuang, Hebei, China
China, Hubei
Research Site
Wuhan, Hubei, China
China, Jiangsu
Research Site
Nanjing, Jiangsu, China
China, Jilin
Research Site
Changchun, Jilin, China
China, Liaoning
Research Site
Shenyang, Liaoning, China
China, Shaanxi
Research Site
Xi an, Shaanxi, China
China, Shanghai
Research Site
Shanghai, Shanghai, China
China, Shanxi
Research Site
Taiyuan, Shanxi, China
China, Sichuan
Research Site
Chengdu, Sichuan, China
China, Zhejiang
Research Site
Hangzhou, Zhejiang, China
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Yilong WU, Professor Guangdong Provincial People's Hospital

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02932345     History of Changes
Other Study ID Numbers: D7913R00020
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017
Keywords provided by AstraZeneca:
EGFR mutation; non-small-cell lung cancer;
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action