Clinical trial · Interventional
Efficacy of Erlotinib in Neoadjuvant Setting in Patients With Stage IIIA, N2-positive Non-Small Cell Lung Cancer
A Phase II Trial of Neoadjuvant Erlotinib (Tarceva®) Followed by Surgery for Selected Patients With Stage IIIA, N2-positive Non-Small Cell Lung Cancer
NCT01130753CI-TRIAL-00010471completedPhase 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 propose neoadjuvant chemotherapeutic role by erlotinib.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Erlotinib | — | UNRESOLVED | — |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoadjuvant Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib | Drug | Erlotinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Pathologic down-staging
- timeFrame
- 36 months
Secondary outcomes (4)
- measure
- Response rate
- timeFrame
- 36 months
- measure
- Toxicity
- timeFrame
- 36 months
- measure
- Progression free survival
- timeFrame
- 36 months
- measure
- Overall survival
- timeFrame
- 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed N2 positive and stage IIIA non-small cell lung cancer * Has more than 2 conditions out of following 3 conditions ; adenocarcinoma, non-smoker, women * 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: * Pulmonary carcinoid tumor * 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.