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.