Clinical trial · Interventional
Stereotactic Radiosurgery or Other Local Ablation Then Erlotinib in Epidermal Growth Factor Receptor (EGFR)
Phase II Study of Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib for Patients With Epidermal Growth Factor Receptor(EGFR) Mutation Who Have Previously Progressed on an Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor (EGFR-TKI)
NCT01573702CI-TRIAL-00049384completedPhase 2Results postedClinicalTrials.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)
\- Progression free survival after locally ablative therapy and erlotinib in EGFR patients progressed after EGFR-TKI therapy
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 |
| Stereotactic Radiosurgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Stereotactic Radiosurgery Followed by Erlotinib
- description
- Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib
- interventionNames
- Procedure: Stereotactic Radiosurgery
- Drug: Erlotinib
Primary outcomes (1)
- measure
- Percentage of Participants With Progression Free Survival
- timeFrame
- 3 months after Initiation of Stereostatic Radiotherapy
- description
- Progression free survival (PFS) after locally ablative therapy and erlotinib in EGFR-mutant NSCLC patients who progressed on prior EGFR-tyrosine kinase inhibitor (TKI) therapy reported as percentage of participants who are alive and without progressive disease at 3 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or the appearance of new lesions.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * 18 years of age or older * Histologically or cytologically confirmed stge IV EGFR-mutant NSCLC * History of previous response to EGFR-TKI defined by a RECIST 1.1 criteria * Progressive disease following EGFR-TKI therapy * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Adequate organ and marrow function * Negative urine or serum pregnancy test for female patients * Patients who can have children must agree to adequate contraception Exclusion Criteria: * Unresolved chronic toxicities greater than 2, measured by CTCAE v4 * Treatment with any FDA approved or experimental cancer treatment following progression on EGFR-TKI * Any history of previous greater than grade 3 toxicity attributable to erlotinib * Pregnant or lactating female * Any previous radiation to sites of planned Stereostatic Radiosurgery * History of another malignancy * Concomitant anticancer therapy, immunotherapy, or radiation therapy (within 4 weeks) * Evidence of severe or uncontrolled systemic diseases * Known hypersensitivity reaction or idiosyncrasy to erlotinib * Psychological, familial, sociological, or geographical conditions * Any other condition in investigator's opinion jeopardize compliance with protocol
References
Publications (0)
Data not yet available
No reference posted for this study.