Clinical trial · Observational
Gefitinib Long-term Survivor Study
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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.
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EGFR Mutation Positive Advanced Non-small-cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Long-term survivors group (case)
- description
- EGFR M+ aNSCLC patients who continuously received gefitinib for at least 3 years
- label
- Rapid PD group (control)
- description
- EGFR M+ aNSCLC patients who had undergone PD after gefitinib treatment≤3 months
Primary outcomes (1)
- 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 (16)
- measure
- Sex
- timeFrame
- at time of Gefitinib treatment initiation,up to 10 years before study start
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available