Clinical trial · Interventional
Erlotinib 100mg or 150mg in Treating EGFR Mutated NSCLC
Phase 3 Study of Erlotinib 100mg or 150mg in Treating EGFR Mutated Patients With Non-small Cell Lung Cancer
NCT02140333CI-TRIAL-00016861unknownPhase 3ClinicalTrials.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 determine whether 100mg erlotinib had similar effect compared with 150mg erlotinib in NSCLC patients with EGFR mutation in China.
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 |
|---|---|---|---|
| EGFR Mutation | — | UNRESOLVED | — |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib | Drug | Erlotinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Erlotinib 100mg
- description
- Erlotinib 100mg
- interventionNames
- Drug: Erlotinib
- type
- ACTIVE_COMPARATOR
- label
- Erlotinib 150mg
- description
- Erlotinib 150mg
- interventionNames
- Drug: Erlotinib
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- 2 years after the initial dose
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histological diagnosis of NSCLC with phase IIIB or IV disease; 2. Sensitive mutation EGFR gene (18, 19 del, 21 L858R gene mutation) (mutation detection methods:ARMS-PCR, sequence method) 3. Never received anti-tumor therapies for the advanced stage; 4. Never used EGFR inhibitors; 5. Measurable disease by RECIST criteria; 6. Male or female patients \>=18 years of age; 7. ECOG karnofsky performance 0\~3, life expectancy is greater than 12 weeks; 8. Patients must be accessible for treatment and follow-up; Exclusion Criteria: 1. Previously used EGFR inhibitors 2. Mix ingredients in patients with squamous cell carcinoma, small cell lung cancer; 3. Allergic to erlotinib; 4. Non-measurable lesions 5. Pregnant or lactating women; 6. Patients having other factors that preventing researchers from enrollment them.
References
Publications (0)
Data not yet available
No reference posted for this study.