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EGFR Mutation Positive Advanced Non-small-cell Lung CancerNCT02932345

Gefitinib Long-term Survivor Study

An observational study of EGFR Mutation Positive Advanced Non-small-cell Lung Cancer, run by AstraZeneca at 14 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 Read more about this study

Who is it for?
Any age
How many people
59 participants
Where
14 sitesChina
Study dates
31 Oct 2016to 4 Jul 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: This study will recruit approximately 150 aNSCLC patients who fulfil the inclusion/exclusion criteria

Who may be able to join

  • For inclusion in the long-term survivors group, the study subjects must fulfil the following criteria at the time of screening:
  • Provision of informed consent or EC approve informed consent waiver prior to any study specific procedures
  • Histological or cytological confirmed locally advanced NSCLC (stage III B) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy
  • EGFR mutation positive
  • Patients who continuously received gefitinib for at least 3 years without evidence of PD
  • Patients with OS ≥ 5 years from NSCLC diagnosis will be preferred
Show all 13Show fewer
  • 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:
  • Provision of informed consent or EC approve informed consent waiver prior to any study specific procedures
  • Histological or cytological confirmed locally advanced NSCLC (stage III B) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy
  • EGFR mutation positive
  • Patients who had undergone PD after gefitinib treatment≤3 months (Rapid PD)
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

China14 sites

  • Research Site

    Beijing, Beijing Municipality

  • Research Site

    Changchun, Jilin

  • Research Site

    Chengdu, Sichuan

  • Research Site

    Fuzhou, Fujian

  • Research Site

    Guangzhou, Guangdong

  • Research Site

    Hangzhou, Zhejiang

  • Research Site

    Nanjing, Jiangsu

  • Research Site

    Shanghai, Shanghai Municipality

  • Research Site

    Shenyang, Liaoning

  • Research Site

    Shijiazhuang, Hebei

  • Research Site

    Taiyuan, Shanxi

  • Research Site

    Wuhan, Hubei

  • Research Site

    Xi'an, Shaanxi

  • Research Site

    Zhengzhou, Henan

Other trials in China

About this 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

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

Keywords
EGFR mutation; non-small-cell lung cancer;
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02932345
Study groupRoleWhat they receive
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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with specific genomic alterations(mutation, copy number change and fusion) of short or long-term survivors

    Measured: at time of sample collection before Gefitinib treatment initiation, up to 10 years before study start

Secondary outcomes (16)

  1. Sex

    Measured: at time of Gefitinib treatment initiation,up to 10 years before study start

  2. Age

    Measured: at time of Gefitinib treatment initiation, up to 10 years before study start

  3. Pre-existing comorbidities at initiation of gefitinib therapy

    Measured: at time of Gefitinib treatment initiation, up to 10 years before study start

  4. Cancer type and date of first ever cancer diagnosis

    Measured: at time of Gefitinib treatment initiation, up to 10 years before study start

  5. Histological subtype

    Measured: 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

    Measured: at time of Gefitinib treatment initiation, up to 10 years before study start

  7. EGFR mutation status

    Measured: at time of Gefitinib treatment initiation, up to 10 years before study start

  8. Smoking status

    Measured: at time of Gefitinib treatment initiation, up to 10 years before study start

  9. ECOG performance status at time of Gefitinib treatment initiation

    Measured: at time of Gefitinib treatment initiation, up to 10 years before study start

  10. Gefitinib treatment patterns- Starting dose

    Measured: at time of Gefitinib treatment initiation, up to 10 years before study start

  11. Gefitinib treatment patterns- Dose reductions, treatment interruptions, discontinuation including reasons

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: from Gefitinib treatment initiation to study completion, up to 12 years

  15. Progression Free Survival (PFS)

    Measured: from Gefitinib treatment initiation to disease progression or study completion, whichever occurred first, up to 12 years

  16. Overval survival (OS)

    Measured: from Gefitinib treatment initiation to death or study completion, whichever occurred first, up to 12 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2016 (estimated)
  2. Study start31 Oct 2016
  3. Primary completion4 Jul 2017
  4. Study completion4 Jul 2017

Why it stopped: Due to strategic decision, AZ has applied to terminate study at all participating sites and has committed that the data generated during the course of the study will not be submitted to China National Medical Products Administration.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02932345
Sponsor's protocol ID
D7913R00020
Status last verified
Dec 2021
First submitted
12 Sep 2016
Last updated
24 Mar 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of EGFR Mutation Positive Advanced Non-small-cell Lung Cancer, run by AstraZeneca at 14 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Due to strategic decision, AZ has applied to terminate study at all participating sites and has committed that the data generated during the course of the study will not be submitted to China National Medical Products Administration.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02932345.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.

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