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. 2021 Jul;10(7):3369–3384. doi: 10.21037/tlcr-20-1134

Table 1. Ongoing clinical trials including TME evaluation in OMD/OPD lung cancer.

Phase ClinicalTrials.gov identifier Setting N Treatment Type of tumor sample Primary endpoints Secondary endpoints Status
IIb NCT04216121 OPD EGFR-mutant NSCLC 39 LAT (SBRT or surgery) + first line osimertinib Surgical specimen1 PFS2 Time to next line systemic therapy; patterns of progression to LAT; QoL Active, recruiting
II NCT02759835 OPD EGFR-mutant NSCLC 37 LAT (surgery, RT, radiofrequency ablation) before or after the start of osimertinib(any line) Surgical specimen1 Liquid biopsy PFS, PFS2 RR, OS Active, not recruiting
II NCT03808662 OPD triple negative breast cancer or NSCLC 160 SBRT to all the OPD sites vs. SOC Tissue biopsy2 PFS OS Active, recruiting
II NCT04255836 OMD NSCLC 35 Durvalumab + first line (carboplatin + paclitaxel or cisplatin + pemetrexed) + SBRT Tissue biopsy2 PFS ORR, OS, Safety Active, not recruiting
II/III NCT02759783 Extracranial OMD prostate cancer, breast cancer or NSCLC 245 SOC +/− SBRT Tissue biopsy2 PFS OS, local lesion control, QoL, FFWMD Active, not recruiting
II NCT02316002 OMD NSCLC 51 Pembrolizumab after definitive therapy Tissue biopsy or surgical specimen2 PFS Active, not recruiting
III NCT03391869 Stage IV NSCLC 270 Nivolumab + ipilimumab +/− LCT Tissue biopsy or cytological sample2 OS; OS in OMD subgroup PFS, TANM Active, recruiting
III NCT02076477 OMD NSCLC 420 CT (cisplatin + docetaxel or pemetrexed) + RT Tissue biopsy or cytological sample2 RR PFS Active, recruiting
II NCT03965468 OMD NSCLC 47 Durvalumab + carboplatin-paclitaxel + SBRT on all the metastatic sites + surgery or radical RT on the primary Surgical specimen1 PFS OS, OR, DoR, distant PFS Active, recruiting
II NCT03410043 Stage IIIB or IV EGFR-mutated NSCLC 143 Osimertinib +/− LAT (surgery and/or RT) Surgicalspecimen1 PFS OS; PFS in OMD subgroup; TANM; time to progression of target lesions Active, recruiting
III NCT03827577 OMD NSCLC 195 SOC +/− LAT of all metastatic sites and resection of the primary Surgical specimen3 OS Active, recruiting

1, surgical specimen available if LAT is performed with surgery of the oligometastatic sites; 2, baseline tissue biopsy, cytological sample or surgical specimen (either on primary tumor or on metastasis); 3, surgical specimen of primary and/or of all oligometastases. N, number; OPD, oligoprogressive disease; NSCLC, non-small cell lung cancer; LAT, local ablative therapy; SBRT, stereotactic body radiotherapy; PFS, progression free survival; PFS2, progression free survival (at second progression); QoL, quality of life; RT, radiotherapy; RR, response rate; OS, overall survival; SOC, standard of care; OMD, oligometastatic disease; ORR, overall response rate; FFWMD, freedom from widespread metastatic disease; LCT, Local Consolidation Therapy; TANM, Time to Appearance of New Metastases; CT, chemotherapy; OR, overall response; DoR, duration of response.