Clinical trial · Interventional
SRT for Residual Oligometastases of NSCLC After 3rd Generation EGFR-TKIs
An Open-label, Single-Arm, Phase 2 Trial of Stereotactic Radiotherapy for Patients With Residual Oligometastases of NSCLC After 3rd Generation EGFR-TKIs
NCT04764214CI-TRIAL-00079887completedPhase 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 is an open-label, single-arm phase 2 trial to evaluate the efficacy and safety of stereotactic radiotherapy (SRT) for patients with oligo-residual NSCLC after 3rd generation EGFR-TKIs.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EGFR Activating Mutation | — | UNRESOLVED | — |
| NSCLC Stage IV | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3rd generation EGFR-TKI | Drug | — | UNRESOLVED |
| Consolidative SRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 3rd generation EGFR-TKI+ SRT
- description
- Patients were treated with the intent to ablate all residual disease with consolidative SRT. EGFR-TKI treatment was continued during and after consolidative SRT until disease progression or intolerable toxicity.
- interventionNames
- Drug: 3rd generation EGFR-TKI
- Radiation: Consolidative SRT
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- Two years
- description
- PFS was measured from the date of enrollment to the date of disease progression as defined by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 or death due to any cause, whichever occurred first. For patients whose disease did not progress, PFS was evaluated by censoring patients at their most recent imaging.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * The patient has a diagnosis of pathologically confirmed NSCLC by tumor biopsy and/or fine-needle aspiration. * The patient has a diagnosis of American Joint Committee on Cancer (AJCC) 8th Edition stage IV NSCLC. * The patient receives 3rd generation EGFR-TKI in the first line setting. * The patient is ≥18 years of age and ≤75 years of age at the time of screening. * The patient's Karnofsky performance score (KPS) is ≥70 at study entry. * The patient has adequate baseline tumor assessment before initiation of 3rd generation EGFR-TKI. * The patient has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. * The patient presents with a residual "oligometastatic" state after 3rd generation EGFR-TKI therapy that would be amenable to consolidative SRT in the opinion of the investigator. * The patient has signed informed consent. * EGFR Exon19 deletion or Exon21 L858R mutation Exclusion Criteria: * History of another malignancy or concurrent malignancy. Patients with cervical carcinoma in situ or adequately treated basal cell carcinoma who have been disease free for \> 5 years are eligible. * The patient is pregnant (confirmed by serum b-HCG if applicable) or is breastfeeding. * Patients with uncontrolled epilepsy, mental disorders, drug abuse, or social condition that may affect compliance or ability to sign a written informed consent in the opinion of the investigator. * Patients with residual metastatic disease after 3rd generation EGFR-TKI therapy that is deemed not amenable to consolidative SRT.
References
Publications (1)
- DERIVEDZhou Y, Peng L, Liang F, Chu L, Chu X, Yang X, Zhang J, Guo T, Jiang S, Pang Y, Wang Z, Zhang L, Ni J, Zhu Z. Safety and efficacy of consolidative stereotactic radiotherapy for oligo-residual EGFR-mutant non-small cell lung cancer after first-line third-generation EGFR-tyrosine kinase inhibitors: a single-arm, phase 2 trial. EClinicalMedicine. 2024 Sep 26;76:102853. doi: 10.1016/j.eclinm.2024.102853. eCollection 2024 Oct. PMID 39398493