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TerminatedNCT02932345Updated Mar 24, 2022

Gefitinib Long-term Survivor Study

An observational study in EGFR Mutation Positive Advanced Non-small-cell Lung Cancer, sponsored by AstraZeneca. Terminated at 14 sites in China. Per ClinicalTrials.gov, last updated 2022-03-24.

Sponsored by AstraZeneca · Observational

Why this study was terminated
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.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
59
Sex
All
01

Study 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

02

Conditions studied

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

Keywords

  • EGFR mutation; non-small-cell lung cancer;
03

In context

Carcinoma, Non-Small-Cell Lung

6,645 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.

This study's enrollment of 59 is below the median of 164 across 974 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,492 studies on the registry; 265 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.

Browse AstraZeneca studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
59 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

14 sites
  • Research Site
    Beijing, Beijing Municipality, China
  • Research Site
    Fuzhou, Fujian, China
  • Research Site
    Guangzhou, Guangdong, China
  • Research Site
    Shijiazhuang, Hebei, China
  • Research Site
    Zhengzhou, Henan, China
  • Research Site
    Wuhan, Hubei, China
  • Research Site
    Nanjing, Jiangsu, China
  • Research Site
    Changchun, Jilin, China
  • Research Site
    Shenyang, Liaoning, China
  • Research Site
    Xi'an, Shaanxi, China
  • Research Site
    Shanghai, Shanghai Municipality, China
  • Research Site
    Taiyuan, Shanxi, China
  • Research Site
    Chengdu, Sichuan, China
  • Research Site
    Hangzhou, Zhejiang, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2016 to primary completion in Jul 2017, 8 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2016
First posted
Oct 13, 2016
StartActual
Oct 31, 2016
Primary completionActual
Jul 4, 2017
CompletionActual
Jul 4, 2017
Last update
Mar 24, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02932345
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Oct 13, 2016
Start date
Oct 31, 2016
Primary completion
Jul 4, 2017
Completion
Jul 4, 2017
Last update
Mar 24, 2022

Study contacts

Yilong WU, Professor
principal investigator · Guangdong Provincial People's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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