Clinical trial · Interventional
Neoadjuvant Erlotinib for Operable Stage II or IIIA NSCLC With EGFR Mutations
A Phase II Study of Neo-adjuvant Erlotinib for Operable Stage IIB or IIIA Non-small Cell Lunc Cancer With Epidermal Growth Factor Receptor Activation Mutations
NCT01470716CI-TRIAL-00057591unknownPhase 2ClinicalTrials.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)
This study examines preoperative Erlotinib in patients with operable stage II and IIIA Non-small-cell lung cancer (NSCLC) harboring EGFR mutations.
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 |
|---|---|---|---|
| NSCLC Stage II | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| NSCLC, Stage IIIA | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib | Drug | Erlotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study arm
- description
- Neo-adjuvant Erlotinib treatment arm.
- interventionNames
- Drug: Erlotinib
Primary outcomes (1)
- measure
- Progression-Free survival
- timeFrame
- every 8 week
- description
- Progression free survival will be calculated from the date of study treatment start to the first objective documentation of progressive disease or to the date of death, whichever occurs first.
Secondary outcomes (3)
- measure
- Response rate
- timeFrame
- every 4 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed stage II \& IIIA non-small cell lung cancer * EGFR exon 19 or 21 mutations * Age ≥ 18 years and ECOG performance 0\~1 * Has measurable lesion by RECIST 1.1 * No previous chemotherapy or radiation therapy * Adequate organ function by following; ANC ≥1,500/uL, hemoglobin ≥9.0g/dL, platelet ≥100,000/uL, PaO2 ≥ 60 mmHg, Serum Cr \< 1 x UNL or creatinine clearance \> 60 ml/min, Serum bilirubin \< 1 x UNL, AST (SGOT) and ALT (SGPT) \< 2.5 x UNL, alkaline phosphatase \< 5 x UNL * Written informed consent form Exclusion Criteria: * Previous chemotherapy or radiation therapy * Previous history of malignancy within 5 years from study entry except treated non-melanomatous skin cancer or uterine cervical cancer in situ * Known allergic history of erlotinib * Interstitial lung disease or fibrosis on chest radiogram * Active infection, uncontrolled systemic disease (cardiopulmonary insufficiency, fatal arrhythmias, hepatitis) * Pregnant or nursing women
References
Publications (0)
Data not yet available
No reference posted for this study.