Clinical trial · Observational
A Prospective Observational Study Evaluating c-MET Expression and EGFR Gene Mutation Correlation With Erlotinib Response
Phase 4 Study of Response to EGFR-TKI and Correlation With C-met Expression and EGFR Gene Mutation in NSCLC Patients Treated With Erlotinib
- 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)
1. Trial design: Prospective observational study 2. Target population: 200 NSCLC patients with histologically or cytologically confirmed stage IV or recurrent NSCLC who have progressive disease after 1st line chemotherapy who consent for study participation and meet the study selection criteria 3. Primary objective: To investigate C-met expression/amplification and EGFR gene mutations in NSCLC patients treated with Erlotinib * C-met expression by IHC C-met amplification by SISH EGFR mutation by real time PCR 4. We will also assess the correlation of EGFR mutations and c-MET with clinical outcome (Overall Response Rate, Progression Free survival ) 5. Duration of Trial Recruitment: 2 years
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer Metastatic | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Erlotinib treatment
Primary outcomes (1)
- measure
- The rates of C-met expression/amplification and EGFR gene mutations
- timeFrame
- Average of 1 year
- description
- To investigate C-met expression/amplification and EGFR gene mutations in NSCLC patients treated with Erlotinib : C-met expression by IHC C-met amplification by SISH EGFR mutation by real time PCR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Informed consent * 19\~80 year old male or female * Histologically proven advanced or metastatic NSCLC * Failed to 1st line chemotherapy * Tumor tissue for genetic analysis * Evaluable target lesion by RECIST v1.1 * ECOG performance from 0 to 3 * Expected survival more than 12 weeks Exclusion Criteria: * Previous treatment of EGFR-tyrosine kinase inhibitors * Severe hypersensitivity to erlotinib * Residual toxicities (above grade 2) after previous chemotherapy * Total bilirubin more than 1.5x of upper normal limit Liver function tests more than 2.5x of upper normal limits
References
Publications (0)
Data not yet available