Clinical trial · Interventional
First-line Treatment for Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation
An Open-label, Multi-centre Study to Evaluate Efficacy and Safety of Gefitinib as the First-line Treatment for Locally Advanced (IIIB), Metastatic (IV) or Recurrent Pulmonary Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation.
NCT00344773CI-TRIAL-00003611completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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 this study is to evaluate the overall objective tumor response rate (ORR) of Gefitinib.
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 |
|---|---|---|---|
| Pulmonary Cancer | Lung Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gefitinib | Drug | Gefitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gefitinib
- description
- Gefitinib 250mg tablet once daily
- interventionNames
- Drug: Gefitinib
Primary outcomes (1)
- measure
- Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.
- timeFrame
- baseline to 12 months
- description
- Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients. RECIST criteria: CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diameter of target lesions PD = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet above criteria
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Patients require histological biopsy and paraffin block more than 5mg from the original tumour or metastatic site to perform EGFR mutational analysis * WHO Performance Status 0-2 * No prior chemotherapy, biological or immunological therapy/surgery Exclusion Criteria: * Any evidence of clinically active interstitial lung disease * Newly diagnosed CNS metastases that have not yet been definitively treated with surgery /radiation * Patients with previously diagnosed and treated CNS metastases or spinal cord compression
References
Publications (1)
- DERIVEDKim DW, Lee SH, Lee JS, Lee MA, Kang JH, Kim SY, Shin SW, Kim HK, Heo DS. A multicenter phase II study to evaluate the efficacy and safety of gefitinib as first-line treatment for Korean patients with advanced pulmonary adenocarcinoma harboring EGFR mutations. Lung Cancer. 2011 Jan;71(1):65-9. doi: 10.1016/j.lungcan.2010.04.005. PMID 20430469