Table 4.
Selected ongoing clinical trials investigating the combination of target therapies and RT in NSCLC patients with BMs.
| NCT identifier | Study phase | Number of patients estimated | Study population | Standard arm | Experimental arm | Primary endpoint |
|---|---|---|---|---|---|---|
| NCT03535363 (Case Comprehensive Cancer Center) | I | 6 (actual enrolment) | Stage IV EGFR Mutated with 1-10 BMs | – | Osimertinib before, concurrently and after SRS | MTD of Osimertinib with SRS |
| NCT04147728 (Peking University Third Hospital) | II | 50 | Limited BMs (1-5) | – | Anlotinib + SRS | Edema Index |
| NCT04905550 (Chongqing University Cancer Hospital Chongqing) | II | 50 | Stage IV EGFR Mutated with BMs | – | Almonertinib + SRT or SRS or WBRT | iPFS |
| NCT03769103 (British Columbia Cancer Agency) | II | 76 | Stage IV EGFR Mutated with BMs | SRS + Osimertinib | Osimertinib alone | iPFS |
| NCT03497767 (Trans Tasman Radiation Oncology Group) | II | 80 | EGFR-mutated NSCLC with BMs diagnosed de novo or developed while on first-line EGFR-TKI | – | A. : Osimertinib aloneB. : Upfront SRS followed by Osimertinib | 1y iPFS |
| NCT04829019 (Department of Medical Oncology, Cancer Center of Sun Yat-Sen University Guangzhou) | II | 88 | EGFR-mutated NSCLC with BMs | Osimertinib + WBRT | Osimertinib | NCF |
| NCT02726568 (West China Hospital Chengdu) | II | 30 | EGFR-mutated NSCLC with BMs | – | Icotinib + SRS when intracranial progression | iPFS |
| NCT03754530 | II | 162 | EGFR-mutated NSCLC with BMs | – | A. : IcotinibB. : Icotinib + RT (WBRT or SRS) | iPFS |
| NCT04193007 (The Second Affiliated Hospital of Nanchang University Nanchang) | II | 100 | Asymptomatic NSCLC BMs with Gene-Sensitive Mutation | Molecular targeted therapy (EGFR-TKI or the first generation of ALK inhibitors) | Brain Radiotherapy and molecular targeted therapy | iPFS, ORR |
| NCT04058704 (Zhejiang Cancer Hospital Hangzhou) | III | 296 | EGFR-mutated NSCLC with BMs | – | A. : Early intervention (Icotinib + RT)B. : Late intervention (Icotinib + RT | OS |
| NCT02714010 (Sun Yat-sen University of cancer center Recruiting Guangzhou) | III | 601 | Stage IV EGFR Mutated with BMs | EGFR-TKI + concurrent WBRT | EGFR-TKI alone till tumor progression | iPFS |
| NCT02882984 (Sichuan PPH, Cancer Center Recruiting Chengdu) | III | 325 | Stage IV EGFR Mutated with BMs | WBRT along with TKI | HFSRS with EGFR TKI | iPFS |
NA, not applicable; WBRT, Whole Brain Radiation Therapy; SRS, Radiosurgery; SRT, fractionated stereotactic radiotherapy; EGFR, Epidermal Growth Factor Receptor; TKI, Tyrosin Kinase Inhibitor; iPFS, Progression Free Survival; MTD, Maximum Tolerated Dose; NCF,NeuroCognitive Function; OS,Overall Survival; ORR, Overall Response Rate.