Clinical trial · Interventional
SRS Study in Patients With Non-Small Cell Lung Cancer
Phase II Stereotactic Body Radiotherapy for Stage I (T1-T2, N0, M0), Selective Stage II (Chest Wall T3, N0M0) or Isolated Peripheral Lung Recurrent Non-Small Cell Lung Cancer (NSCLC)
- 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)
The goal of this clinical research study is to learn if stereotactic body radiotherapy (SBRT) can help to control NSCLC. The safety of SBRT will also be studied. Objectives: To assess therapeutic efficacy and toxicities of stereotactic body radiotherapy (SBRT) for patients with medically inoperable stage I (T1-2, N0,M0), selective stage II (chest wall T3, N0M0) or isolated peripheral lung recurrent non-small cell lung cancer (NSCLC). Primary goal: Improve 2 years progression free survival at the treated primary tumor site. Secondary goals: 1. Improve disease free survival, disease specific survival and overall survival at 2 years. 2. Decrease grade 3 and above acute and/or chronic toxicities. 3. Collect blood for future biomarkers study
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- Stereotactic Body Radiation Therapy (SBRT) Stage I NSCLC
- interventionNames
- Procedure: Stereotactic Body Radiation Therapy (SBRT)
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- Stereotactic Body Radiation Therapy (SBRT) Selective Stage II NSCLC
- interventionNames
- Procedure: Stereotactic Body Radiation Therapy (SBRT)
- type
- EXPERIMENTAL
- label
- Cohort 3
- description
- Stereotactic Body Radiation Therapy (SBRT) Isolated Peripheral Lung Recurrent NSCLC
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Cohort 1: Histologically or cytologically documented NSCLC. 2. Cohort 1: Inoperable stage IA (T1N0MO), IB (T2N0MO) and selective stage II (T3 due to chest wall involvement, N0M0). Patient refuses surgery is eligible. Secondary lung cancer is eligible if primary cancers have been cured or stable with life expectance longer than 2 years. If primary cancer is lung cancer, patient needs to be lung cancer free for more than 5 year for same histology or more than 2 years for different histology. 3. Cohort 1: Patients with hilar or mediastinal lymph nodes \<= 1cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Patients with \> 1 cm hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but on-diagnostic uptake) may still be eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer. Patient who received induction chemotherapy or other systemic therapy are eligible. 4. Cohort 1: Performance score Karnofsky performance status (KPS) 60-100. 5. Cohort 2: Histologically or cytologically documented NSCLC. 6. Cohort 2: Inoperable isolated lung parenchyma recurrent NSCLC without evidence of lymph node or mediastinal involvement (clinical stage T1-2, chest wall involvement T3, N0M0) after surgical resection or definitive radiotherapy with/without chemotherapy. Recurrent disease is defined as NSCLC with same histology, same lobe that recurs within 5 years after initial definitive therapy. Patient refuses surgery is also eligible. Patient received systemic therapy is eligible. 7. Cohort 2: Performance score KPS 60-100. 8. Cohort 3: Histologically or cytologically documented NSCLC. 9. Cohort 3: Previous history of NSCLC that has been cured or stable. New development of inoperable isolated lung parenchyma lesion that has been documented histologically or cytologically as NSCLC without evidence of lymph node or mediastinal involvement (clinical stage T1-2, chest wall involvement T3, N0M0) and not eligible for cohort 1 and recurrent disease as defined in Cohort 2. This includes NSCLC happens within 5 years after initial definitive treatment of prior NSCLC, and/or is located in the different lobes. 10. (cont.) Cohort 3: Possible stage IV disease is eligible as long as it meets the criteria above since there is no definitive way to confirm it. Patient refuses surgery is eligible. Patient received systemic therapy is eligible. 11. Cohort 3: Performance score KPS 60-100. Exclusion Criteria: 1. Any tumor involving main bronchus, major vessels, heart, esophagus, trachea, carina, spinal cord. 2. Any tumor that causes collapsed lobe of lung. 3. Any tumor with malignant pleural effusion. 4. Direct evidence of hilar, mediastinal lymph node or distant metastasis based on staging work up. 5. Pregnancy. Patients (men and women) of child bearing potential should use an effective (for them) method of birth control throughout their participation in this study.
References
Publications (1)
- DERIVEDSun B, Brooks ED, Komaki R, Liao Z, Jeter M, McAleer M, Balter PA, Welsh JD, O'Reilly M, Gomez D, Hahn SM, Sepesi B, Rice DC, Heymach JV, Chang JY. Long-Term Outcomes of Salvage Stereotactic Ablative Radiotherapy for Isolated Lung Recurrence of Non-Small Cell Lung Cancer: A Phase II Clinical Trial. J Thorac Oncol. 2017 Jun;12(6):983-992. doi: 10.1016/j.jtho.2017.02.018. Epub 2017 Mar 1. PMID 28259750