Table 2.
Ongoing registered clinical trials of immune checkpoint inhibitors in advanced cancers that are expected to recruit patients with lung carcinoids.
| ClinicalTrials.gov Identifier | First Posted | Molecule | Trial Name | Phase | Assigned Intervention | Primary Outcome | Estimated Study Completion Date | Trial Status |
|---|---|---|---|---|---|---|---|---|
| NCT02628067 | 11 December 2015 | Pembrolizumab | A clinical trial of pembrolizumab (MK-3475) evaluating predictive biomarkers in subjects with advanced solid tumors (KEYNOTE 158) | Phase II | Arm I: pembrolizumab 200 mg IV on day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years of treatment); arm II: pembrolizumab 400 mg every 6 weeks for up to 18 administrations (up to approximately 2 years of treatment) | Objective response rate (time frame: up to approximately 2 years) | 18 June 2026 | Recruiting |
| NCT02923934 | 5 October 2016 | Nivolumab + ipilimumab | A phase II clinical trial evaluating ipilimumab and nivolumab in combination for the treatment of rare gastrointestinal, neuro-endocrine and gynaecological cancers | Phase II | Nivolumab at 3 mg/kg + ipilimumab at 1 mg/kg concurrently every 3 weeks for 4 doses followed by nivolumab only at 3 mg/kg every 2 weeks until progression (up to 48 total doses of nivolumab) | CBR (time frame: at 12 weeks following randomization then every 6 weeks until disease progression) | December 2023 | Active, not recruiting |
| NCT03074513 | 8 March 2017 | Atezolizumab + bevacizumab | A phase II, single-arm open-label study of the combination of atezolizumab and bevacizumab in rare solid tumors | Phase II | Atezolizumab + bevacizumab IV over 60 min on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity | Objective response (time frame: up to 4 years) | 31 March 2021 | Active, not recruiting |
| NCT03095274 | 29 March 2017 | Durvalumab + tremelimumab | A phase II study of durvalumab (MEDI4736) plus tremelimumab for the treatment of patients with advanced neuroendocrine neoplasms of gastroenteropancreatic or lung origin (the DUNE Trial) | Phase II | Durvalumab, 1500 mg every 4 weeks for 12 months + tremelimumab 75 mg every 4 weeks for up to 4 doses/cycles | CBR (time frame: 9 months) | April 2022 | Recruiting |
| NCT03110978 | 12 April 2017 | Nivolumab + SABR | Phase II randomized clinical trials comparing immunotherapy plus stereotactic ablative radiotherapy (I-SABR) versus SABR alone for stage I, selected stage IIa, or isolated lung parenchymal recurrent Non-small cell lung cancer: I-SABR | Phase II | Arm I: SABR over 1–2 weeks; arm II: SABR over 1–2 weeks + nivolumab IV over 30 min on day 1. Cycles with nivolumab repeat every 4 weeks for up to 12 weeks | Event-free survival (time frame: from the randomization date, assessed up to 5 years) | 30 June 2022 | Recruiting |
| NCT03420521 | 5 February 2018 | Nivolumab + ipilimumab | An open-label, single arm phase II study of nivolumab in combination with ipilimumab in subjects with advanced neuroendocrine tumors | Phase II | Nivolumab 240 mg IV over 60 min every 2 weeks + ipilimumab 1 mg/kg IV over 30 min every 6 weeks | Objective response rate [time frame: 6-weeks post-intervention] | 1 May 2024 | Active, not recruiting |
| NCT03728361 | 2 November 2018 | Nivolumab + temozolomide | A phase II, multi-cohort trial of combination nivolumab and temozolomide in recurrent/refractory small-cell lung cancer and advanced neuroendocrine tumors | Phase II | Nivolumab IV on day 1 of a 28-day cycle + temozolomide PO on days 1–5. Courses repeat every 28 days | Objective response rate [time frame: up to 3 years] | 31 December 2021 | Active, not recruiting |
| NCT04197310 | 13 December 2019 | Nivolumab + cabozantinib | phase II trial of cabozantinib in combination with nivolumab for advanced carcinoid tumors | Phase II | Nivolumab 240 mg, IV, day 1 and 15 of a 28-day cycle + cabozantinib 40 mg, orally, daily for a 28 day cycle | Objective response rate (time frame: 2 years) | 26 December 2022 | Recruiting |
| NCT04579757 | 8 October 2020 | Tislelizumab + surufatinib | Surufatinib in combination with tislelizumab in subjects with advanced solid tumors | Phase Ib/II | Part 1 (dose escalation): surufatinib PO once daily + tislelizumab 200 mg IV every 3 weeks; Part 2 (dose expansion): surufatinib at the recommended phase 2 dose as determined in Part 1 + 200 mg tislelizumab IV, every 3 weeks | Part 1: Incidence of dose limiting toxicity (time frame: up to 60 days) Part 2: objective response rate (time frame: up to 2 years) |
27 February 2023 | Recruiting |
CBR, clinical benefit rate; IV, intravenously; PO, per os; SABR, stereotactic ablative radiotherapy.