Current treatment landscape for oligometastatic non-small cell lung cancer

Table 1 Main studies on stereotactic body radiotherapy for the treatment of oligometastatic non-small cell lung carcinoma

Ref.	Year	Patients (n)	Site of oligo-metastasis	N	Dose (Gy/fraction)	Systemic therapy	Median follow-up (mo)	Median PFS (mo)	Median OS (mo)
Retrospective studies
Inoue et al[27]	2010	411	Brain, lung, adrenal	< 5	48/8 (adrenal)35-60/4-8 (lung)	NA	20	3-yr PFS 20%	24
Hasselle et al[28]	2012	25	Multiple	< 5	24-70/3-20	Various	21	4.2 (all); 12 (1 met)	23 (1 met)
De Rose et al[26]	2016	60	Lung	< 5	48-60/3-8	Chemo	28	32.2 (actuarial)	32.1 (actuarial)
Single arm prospective trials
Salama et al[23]	2012	611	Multiple	< 5	24-48/3	Chemo	20.9	2-yr PFS 22%	2-yr OS 56.7%
De Ruysscher et al[20]	2012	40	Multiple	< 5	54/32	Chemo	27.7	12.1	13.5
Collen et al[29]	2014	26	Multiple	< 5	50/10	Chemo	16.4	11.2	23
Randomized phase II trials
Gomez et al[25]	2016	49	Multiple	< 3	NR	Chemo	12.4	14.2 vs 4.4	41.2 vs 17
Iyengar et al[10]	2018	29	Multiple	< 5	21-37.5/1-5	Chemo	9.6	9.7 vs 3.5	Not reached vs 17
Palma et al[11]	2019	99	Multiple	< 5	35-60/3-8	Chemo	25	12 vs 6	41 vs 28

¹Diverse primary histology including non-small cell lung carcinoma.

²Only 1patient received stereotactic body radiotherapy.

Chemo: Chemotherapy; N: Number of oligometastatic lesions per patient; NA: Not applicable; NR: Not reported; OS: Overall survival; PFS: Progression-free survival.

Table 2 Ongoing studies on stereotactic body radiotherapy in oligometastatic non-small cell lung carcinoma

Title	Patients	Study design	Estimated completion
Stereotactic Ablative Radiotherapy for Oligometastatic Non-Small Cell Lung Cancer. A Randomised Phase III Trial	340	Phase 3 multicenter: chemotherapy alone or chemotherapy + radical radiotherapy (conventional RT and SABR)	August 2022
Institution: University College London
		Primary histology: all NSCLC
		1-3 oligometastatic lesions
		Primary outcome measure: OS
Clinical Trials.gov identifier: NCT02417662
Maintenance Systemic Therapy Versus Local Consolidative Therapy (LCT) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial (NRG LU-002)	400	Phase 2/3 multicenter: maintenance chemotherapy or SBRT + maintenance chemotherapy	August 2022
		Primary histology: all NSCLC
		1-3 oligometastatic lesions
Institution: NRG Oncology
		Primary outcome measure: PFS
Clinical Trials.gov identifier: NCT03137771
Randomized Phase III Trial of Local Consolidation Therapy after Nivolumab and Ipilimumab for Immunotherapy-naive Patients with Metastatic NSCLC (LONESTAR)-Strategic Alliance: BMS	360	Phase 3 multicenter; systemic treatment only with nivolumab and ipilimumab, or induction nivolumab and ipilimumab followed by local consolidative therapy with surgery and/or radiotherapy	December 2022
Institution: M.D. Anderson Cancer Center		Primary histology: all NSCLC
		1 oligometastatic lesions
Clinical Trials.gov identifier: NCT03391869
		Primary outcome: OS
A Randomised Trial of Conventional Care Versus Radioablation (Stereotactic Body Radiotherapy) for Extracranial Oligometastases	245	Phase 2/3 multicenter: standard of care + SBRTPrimary histology: breast, prostate or NSCLC	October 2024
		1-3 oligometastatic lesions
Institution: Royal Marsden NHS Foundation Trust
		Primary outcome measure: PFS
Clinical Trials.gov identifier: NCT02759783
A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of 4-10 Oligometastatic Tumors (SABR-COMET 10)	159	Phase 3 multicenter: stereotactic ablative radiotherapy, plus standard of care treatment; chemotherapy, immunotherapy, hormones, or observation given at the discretion of the treating oncologist	January 2029
Institution: Lawson Health Research Institute
Clinical Trials.gov identifier: NCT03721341
		Various histology including NSCLC
		4-10 oligometastatic lesions
		Primary outcome: OS
Randomized Phase II Trial of Osimertinib With or Without Local Consolidation Therapy (LCT) for Patients With EGFR-Mutant Metastatic NSCLC (NORTHSTAR)	143	Phase 2 multicenter: osimertinib followed by local consolidative therapy with surgery and/or radiotherapy or maintenance osimertinib alonePrimary histology: NSCLC	January 2023
Institution: M.D. Anderson Cancer Center
		> 1oligometastatic lesion
		Primary outcome: PFS
Clinical Trials.gov identifier: NCT03410043
A Multicenter Single Arm Phase II Trial Assessing the Efficacy of Immunotherapy, Chemotherapy and Stereotactic Radiotherapy to Metastases Followed by Definitive Surgery or Radiotherapy to the Primary Tumor, in Patients With Synchronous Oligometastatic Non-small Cell Lung Cancer	47	Phase 2 multicenter: durvalumab, carboplatin/paclitaxel chemotherapy, followed by SBRT to all oligometastases. Restaging at 3 mo definitive local treatment with surgical resection of primary tumor or RT 60-66 Gy to the primary tumor if not disease progression	December 2023
Institution: European Thoracic Oncology Platform
		1-3 oligometastatic lesions
		Primary outcome: PFS
Clinical Trials.gov identifier: NCT03965468

OS: Overall survival; PFS: Progression-free survival; RT: Radiotherapy; SABR: Stereotactic ablation radiotherapy; SBRT: Stereotactic body radiotherapy.