Clinical trial · Interventional
Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC)
A Phase II Study of Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer
NCT01091376CI-TRIAL-00003452RT0901unknownPhase 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)
Concomitant chemoradiotherapy is the standard treatment of locally advanced,non-resectable, non-small cell lung cancer (NSCLC). However,the optimal chemotherapy regimen is still controversial.The objective of this study was to evaluate the efficacy and toxicity of a concomitant treatment using Erlotinib and radiotherapy followed by Erlotinib consolidation treatment.
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 |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib | Drug | Erlotinib | ALIAS |
| Thoracic radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Concomitant Erlotinib and radiotherapy
- description
- Patients received Erlotinib and radiation therapy.
- interventionNames
- Drug: Erlotinib
- Radiation: Thoracic radiotherapy
Primary outcomes (2)
- measure
- Tumor response rate (Response was analyzed according to the RECIST system, based on CT scans.)
- timeFrame
- After the thoracic radiotherapy and concurrent Erlotinib treatment
- measure
- The safety (The safety was evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0.)
- timeFrame
- Every one month
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven non-small cell lung cancer (squamous cell carcinoma, adenocarcinoma, large cell carcinoma and etc) * Tumor EGFR mutation * Presence of measurable disease by RECIST * stage IIIA or IIIB, non-resectable * ECOG performance status 0-2 * No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy * Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital. Exclusion Criteria: * Carcinoid tumor, small cell carcinoma of lung * Patients with any distant metastasis * History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix * Any other morbidity or situation with contraindication for radiotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment) * Pregnant or lactating women, women who has not taken test of pregnancy (within 7 days before the first administration) and pregnant women * Women and men of childbearing potential who have no willing of employing adequate contraception * Tumor EGFR wild
References
Publications (0)
Data not yet available
No reference posted for this study.