Clinical trial · Interventional
Study of 3D Radiotherapy With or Without Erlotinib (Tarceva®) in Patients With Localized Non-Small Cell Lung Cancer
Phase II Randomized Trial of 3D Radiotherapy Versus the Combination of 3D Radiotherapy and Erlotinib (Tarceva®) in Patients With Localized-Unresectable Non-Small Cell Lung Cancer Non Susceptible for Chemotherapy Treatment.
- 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)
A phase II, multicenter, randomized trial of 3D Radiotherapy versus 3D Radiotherapy and erlotinib (Tarceva®) in patients with localized-unresectable (IA-IIIB) non-small cell lung cancer non susceptible for chemotherapy treatment, to compare safety and toxicity profile, and the progression-free survival in both arms of treatment (3D Radiotherapy versus 3D Radiotherapy + erlotinib) in patients who have not received previous chemotherapy.
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 |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib (Tarceva®) | Drug | Erlotinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- RT + Tarceva
- interventionNames
- Drug: Erlotinib (Tarceva®)
- type
- NO_INTERVENTION
- label
- 2
- description
- RT
Primary outcomes (1)
- measure
- To determinate the viability and toxicity profile of Erlotinib + 3D Radiotherapy treatment (% of patients presenting toxicity 3-4 during the treatment).
Secondary outcomes (4)
- measure
- The progression-free survival.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent prior to any specific procedure of the protocol. * Histologically confirmed diagnosis of non small cell lung cancer. * Unresectable (IA-IIIB) non-small cell lung cancer. * Patients non susceptible for chemotherapy treatment * Measurable disease according to RECIST criteria * Age \> 18 years. * ECOG performance status \< 2. * Adequate bone marrow, hepatic, renal and respiratory function. * Patients capable of following an adequate therapeutic compliance and accessible for a correct follow-up. * Women at a fertile age must have a negative serum or urine pregnancy test within the 7 days prior to the beginning of the treatment. * Patients of both genders at a fertile age, including those women having their last menstruation within the two previous years, must follow effective contraceptive measures. Exclusion Criteria: * Prior chemotherapy or radiotherapy. * History of other curatively treated malignancy and no evidence of disease within the past 5 years except squamous cell skin cancer, or resected cervix carcinoma. * Pregnant or lactating women. * Any other severe disease or clinical conditions, as, but not only: 1. Unstable cardiopathy despite treatment, myocardial infarction within the 6 months before entering the study 2. Uncontrolled active infection 3. Uncontrolled peptic ulcer, unstable diabetes mellitus or any other contraindication for treatment with corticosteroids. 4. Autoimmune diseases. * Concomitant treatment with any other antineoplastic therapy. * Prior experimental pharmacological agent within the 3 weeks prior to the inclusion of the study. * Prior treatment with EGFR targeted therapies. * Erlotinib known hypersensibility. * Any radiotherapy treatment contraindication. * History of significant neurological or psychiatric disorders, including epileptic seizures. * Any significant ophthalmologic impairment of the eye surface (Use of contact lenses is not recommended) * Inability to take oral medication and surgical procedures affecting the absorption or implying intravenous or parenteral feeding. * Any other underlying severe process affecting the ability to take part in the study.
References
Publications (0)
Data not yet available