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. 2021 Mar 16;11(3):e043628. doi: 10.1136/bmjopen-2020-043628

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.