Clinical trial · Interventional
Thoracal Radiotherapy and Tarceva
Concomitant Radiotherapy and Erlotinib in Advanced Lung Cancer
NCT02714530CI-TRIAL-00050949ThoRaTterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
The purpose of this study is to determine if erlotinib given orally along with concurrent palliative irradiation to lung cancer improves local control compared to those treated with radiotherapy alone.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib | Drug | Erlotinib | ALIAS |
| Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radiotherapy combined with erlotinib
- description
- Standard treatment 3 Gy x 10 to lung tumor and mediastinal lymph nodes and erlotinib given concomitantly, 150 mg p.o. daily from the day before radiation, until the last day of radiation.
- interventionNames
- Drug: Erlotinib
- Radiation: Radiation
- type
- ACTIVE_COMPARATOR
- label
- Radiotherapy alone
- description
- Radiotherapy 3 Gy x 10 alone
- interventionNames
- Radiation: Radiation
Primary outcomes (1)
- measure
- Number of patients with progression in radiation field among patients treated with erlotinib combined with radiotherapy compared to radiotherapy alone
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 years * Histological or cytological verified NSCLC * Palliative radiotherapy to thorax indicated * ECOG Performance status 0-2 * Fertile patients must use contraception * Signed informed consent * Ability to understand and fill in QoL questionnaires * Capability to take per os medication * Serum bilirubin \< 2 times upper limit of normal (ULN) * AST and ALT \< 2 times ULN (\< 5 times ULN if liver metastases are present) * Creatinine \< 5 times ULN Exclusion Criteria: * Pregnancy or nursing * Other prior or concurrent malignant disease likely to interfere with study treatment or comparisons * No evidence of other significant laboratory finding or concurrent uncontrolled medical illness, that in the opinion of the investigator, would interfere with study treatment or results comparison or render the patient at high risk for treatment complications * No prior radiotherapy to the same organ / place * No concurrent treatment with other experimental drugs * Known brain metastases in need of radiotherapy * Known hypersensitivity to erlotinib or other substances in the erlotinib tablets.
References
Publications (2)
- DERIVEDNymoen HM, Alver TN, Horndalsveen H, Eide HA, Bjaanaes MM, Brustugun OT, Gronberg BH, Haakensen VD, Helland A. Thoracic radiation in combination with erlotinib-results from a phase 2 randomized trial. Front Oncol. 2024 Aug 1;14:1412716. doi: 10.3389/fonc.2024.1412716. eCollection 2024. PMID 39148905
- DERIVEDAbravan A, Eide HA, Londalen AM, Helland A, Malinen E. Mapping Bone Marrow Response in the Vertebral Column by Positron Emission Tomography Following Radiotherapy and Erlotinib Therapy of Lung Cancer. Mol Imaging Biol. 2019 Apr;21(2):391-398. doi: 10.1007/s11307-018-1226-7. PMID 29916117