Clinical trial · Observational
Retrospective Study in Non Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR)
Retrospective Multicenter Observational Study in NSCLC Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutation Treated First Line by Tyrosine Kinase Inhibitor (TKI)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of our retrospective study is to describe which circumstances EGFR TKI is continued despite progression according to the usual Response Evaluation CrIteria in Solid Tumours (RECIST) in patients with EGFR activating mutations and acquired resistance to EGFR TKI .We will collect their social and demographic data (age, sex), first Progression Free Survival ( PFS) - from start of EGFR TKI to 1st progression PFS 1- and - from first progression according to RECIST to second progression : PFS2- , Overall Survival (OS) - from diagnosis OS 1 and from first progression OS 2 -, mutational status. We will analyze more closely the mode of progression (site), the therapeutic approach at disease progression. We will define two subgroups: those for whom EGFR TKI was continued at least three months despite progression defined according to RECIST criteria, and those for whom a second-line treatment (chemotherapy without EGFR TKI) was chosen at disease progression. It will be individualized the subgroup of patients in whom it was continued TKI after progression.
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 |
|---|---|---|---|
| NSCLC Non Small Cells Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients NSCLC EGFR mutated
- description
- This is an observational study, there is no intervention.
Primary outcomes (1)
- measure
- Proportion of patients continuing TKI at 1st progression and proportion of patients discontinuing EGFR TKI at 1st progression. Analysis of the therapeutic management in the 2 groups. This outcome consists in multiple measures.
- timeFrame
- Patients are followed up to 48 Months maximum
- description
- • Primary outcome: the therapeutic management of secondary resistance to EGFR TKI (erlotinib or gefitinib) in patients with advanced NSCLC with EGFR activating mutation. Comparison of demographic, clinical, biological features and outcome of patients continuing EGFR TKI at progression versus interrupting TKI at progression. Composite measures will be performed : demographic and clinical data, Progression Free Survival (PFS), Overall Survival (OS), mutational status, mode of progression, therapeutic approach at progressive disease in patients with EGFR mutation treated in first line by EGFR TKI (all population and subgroups : patients receiving EGFR-TKI at progressive disease - Group 1 -, patients discontinuing EGFR TKI at progressive disease - Group 2- ).
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Eligibility criteria: * Inclusion criteria: * NSCLC patients with activating mutations of EGFR * First-line treatment with a TKI monotherapy * Measurable lesion according to RECIST 1.1 * Age\> 18 years * secondary or acquired resistance of EGFR TKIs according to the jackman criteria * patients for whom it was started a TKI treatment in first line from January 2010 until June 2012 (patients who received 1 Chemotherapy cycle could be included). * Exclusion criteria: * Patients with small cell carcinoma * Patients without EGFR mutation * Patients not treated with EGFR TKI in first line treatment * Not measurable lesion to RECIST 1.1
References
Publications (1)
- DERIVEDAuliac JB, Fournier C, Audigier Valette C, Perol M, Bizieux A, Vinas F, Decroisette Phan van Ho C, Bota Ouchlif S, Corre R, Le Garff G, Fournel P, Baize N, Lamy R, Vergnenegre A, Arpin D, Marin B, Chouaid C, Gervais R. Impact of Continuing First-Line EGFR Tyrosine Kinase Inhibitor Therapy Beyond RECIST Disease Progression in Patients with Advanced EGFR-Mutated Non-Small-Cell Lung Cancer (NSCLC): Retrospective GFPC 04-13 Study. Target Oncol. 2016 Apr;11(2):167-74. doi: 10.1007/s11523-015-0387-4. PMID 26315967