Table 1.
NCT number | Study population | Treatment regimen | Phase | Important primary outcome | Status | Sponsor |
---|---|---|---|---|---|---|
Ongoing clinical trials with nivolumab and ipilimumab | ||||||
NCT03377023 | Treatment naïve or pretreated advanced or metastatic NSCLC | Nivolumab plus ipilimumab plus nintedanib | Phase I/II nonrandomized, parallel assignment | Phase I: MTD Phase II: ORR |
Recruiting | H. Lee Moffitt Cancer Center |
NCT02983045 | NSCLC cohort consists of treatment naïve, IO naïve, and post anti-PD-1/PD-L1 relapsed or refractory patients | Two experimental arms
|
Phase I/II, nonrandomized, parallel assignment | Safety, tolerability, ORR | Recruiting | Nektar Therapeutics |
NCT03509584 | Advanced NSCLC patients that have received at least one prior line of therapy and eligible for localized palliative XRT | Four experimental arms
|
Phase I, randomized, parallel assignment | Incidence of immune-related adverse events | Not yet recruiting | Assistance Publique Hopitaux De Marseille |
NCT03001882 (Checkmate 592) | Stage IV or recurrent NSCLC with no prior systemic therapy | Nivolumab plus ipilimumab | Phase II, single group assignment | ORR | Recruiting | Bristol-Myers-Squibb |
NCT03425331 | Stage IV NSCLC with no prior systemic anticancer therapy | Nivolumab plus ipilimumab | Phase II, single group assignment | Best overall ORR | Recruiting | Dana-Farber Cancer Center |
NCT03573947 (TOP1705) | Stage IV NSCLC with no prior systemic anticancer therapy | Nivolumab, ipilimumab, and paclitaxel | Phase II, single group assignment | PFS | Recruiting | Jeffery Clarke, Duke University |
NCT03215706 (Checkmate 9LA) | Stage IV NSCLC with no prior systemic anticancer therapy |
|
Phase III, randomized, parallel assignment | OS | Recruiting | Bristol-Myers-Squibb |
NCT03469960 (DICIPLE) | Stage IV NSCLC with no prior systemic anticancer therapy |
|
Phase III, randomized, parallel assignment | PFS | Recruiting | Intergroupe Francophone de Cancerologie Thoracique |
Ongoing trials with durvalumab and tremelimumab | ||||||
NCT03275597 | Chemotherapy naïve or pretreated patients with stage IV NSCLC with six or less extracranial sites for SBRT | Single experimental arm SBRT followed by durvalumab 1500 mg every 4 weeks plus tremelimumab 75 mg every 4 weeks for up to 4 doses. |
Phase Ib, single group assignment | Safety and tolerability | Recruiting | University of Wisconsin |
NCT03057106 | Treatment naïve stage IV NSCLC | Two arms
|
Phase II, randomized, parallel assignment | OS | Active, not recruiting | Canadian Cancer Trials Group |
NCT03164616 (POSEIDON) | Treatment naïve stage IV NSCLC | Two experimental arms and one comparator arm
|
Phase III, randomized, parallel assignment | PFS and OS | Recruiting | AstraZeneca |
Ongoing clinical trials with other anti-PD-1/PD-L1 and anti-CTLA-4 agents | ||||||
NCT03527251 | Locally advanced or metastatic NSCLC | Ipilimumab 1 mg/kg every 34 weeks for two doses followed by anti PD-1 antibody SHR-1210 | Phase 1 | Safety | Recruiting | Sun Yat-sen University |
NCT03580694 | Nonsquamous NSCLC with unresectable stage IIIB or stage IV | Two experimental arms
|
Phase 1 | DLTs, TRAEs, irAEs, SAEs, ORR, PK for cemiplimab and REGN4656 | Recruiting | Regeneron pharmaceuticals |
NCT03430063 (EMPOWER-Lung 4) | Stage IIIB/IIIC not candidates for concurrent chemoradiation and stage IV NSCLC | Three experimental arms
|
Phase II, randomized, open label | ORR | Active, not recruiting | Regeneron pharmaceuticals and Sanofi |
NCT03302234 (Keynote 589) | Treatment naïve stage IV NSCLC with PD-L1>/=50% | Two experimental arms
|
Phase III, randomized, double blinded | OS and PFS | Active, not recruiting | Merck Sharp and Dohme |
NCT03515629 (EMPOWER-Lung 2) | Treatment naïve recurrent or metastatic NSCLC with tumor PD-L1 expression>/=50% | Two experimental arms with one active comparator Experimental arm
Pembrolizumab |
Phase III, randomized, open label, parallel assignment | PFS | Active, not recruiting | Regeneron pharmaceuticals |
Obtained from clinicaltrials.gov, accessed: June 15, 2019.
DLT, dose-limiting toxicity; irAE, immune-related adverse events; MTD, maximum-tolerated dose; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PK, pharmacokinetics; RR, response rate; SAEs, serious adverse events; TRAEs, treatment-related adverse events.