Table 5.
Ongoing randomised studies in oligometastatic NSCLC
SARON | OMEGA | CORE | PROMISE-005 | NRG LU 002 | Current study | |
Trial ID | NCT02417662 | NCT03827577 | NCT02759783 | NCT03808337 | NCT03137771 | CTRI/2020/04/024761 |
Country | UK | Italy | UK | USA | Multicentric | India |
Trial design | RCT III | RCT III | RCT II/III | RCT II | RCT II/III | RCT III |
OM sites (n) | ≤3 | ≤3 | ≤3 | ≤5 | ≤3 | ≤5 |
Presentation Primary Site Oncogene mutation |
Synchronous at least 1 extracranial site NSCLC Negative* |
Synchronous or metachronous NSCLC Negative and Positive |
Metachronous Breast, Prostate, NSCLC – |
Synchronous or metachronous TNBC, NSCLC Negative and Positive |
Synchronous or metachronous (extracranial) NSCLC Negative |
Synchronous NSCLC Negative |
Target accrual | 340 | 195 | 245 | 142 | 300 | 206 |
Control arm Experimental arm |
SMT RT to primary and SBRT for OM |
Systemic therapy Systemic therapy followed by LAT |
SOC SBRT followed by SOC |
SOC SBRT plus SOC |
SMT LCT+SMT |
SMT LCRT+SMT |
Primary end point | OS | OS | PFS/OS | PFS | PFS/OS | OS |
Estimated year of completion | 2022 | 2022 | 2024 | 2022 | 2022 | 2024 |
*Negative indicates for de-novo stage IV non-small cell lung cancer.
LAT, local ablative therapy; LCRT, local consolidation radiation therapy; NSCLC, non-small cell lung cancer; OM, oligometastases; OS, overall survival; PFS, progression-free survival; RCT, randomised controlled trial; SBRT, stereotactic body radiation therapy; SMT, standard maintenance therapy; SOC, standard of care; TNBC, triple-negative breast cancer.