drugset / Trial / NCT04696939
Combined Atezolizumab and Chemotherapy (Carboplatin Plus Etoposide) in Neoadjuvant Treating Limited-Stage Small Cell Lung Cancer Patients
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This Phase II study was designed to evaluate the safety and efficacy of Atezolizumab in combination with Chemotherapy compared with treatment with Chemotherapy alone in previously untreated Limited-Stage Small Cell Lung Cancer patients.
Timeline
- Start
- 2021-01
- Primary completion
- 2022-08
- Completion
- 2023-10
Publications
- Background Paz-Ares L, Dvorkin M, Chen Y, Reinmuth N, Hotta K, Trukhin D, Statsenko G, Hochmair MJ, Ozguroglu M, Ji JH, Voitko O, Poltoratskiy A, Ponce S, Verderame F, Havel L, Bondarenko I, Kazarnowicz A, Losonczy G, Conev NV, Armstrong J, Byrne N, Shire N, Jiang H, Goldman JW; CASPIAN investigators. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial. Lancet. 2019 Nov 23;394(10212):1929-1939. doi: 10.1016/S0140-6736(19)32222-6. Epub 2019 Oct 4.
- Background Horn L, Mansfield AS, Szczesna A, Havel L, Krzakowski M, Hochmair MJ, Huemer F, Losonczy G, Johnson ML, Nishio M, Reck M, Mok T, Lam S, Shames DS, Liu J, Ding B, Lopez-Chavez A, Kabbinavar F, Lin W, Sandler A, Liu SV; IMpower133 Study Group. First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer. N Engl J Med. 2018 Dec 6;379(23):2220-2229. doi: 10.1056/NEJMoa1809064. Epub 2018 Sep 25.
- Background Yang CJ, Chan DY, Shah SA, Yerokun BA, Wang XF, D'Amico TA, Berry MF, Harpole DH Jr. Long-term Survival After Surgery Compared With Concurrent Chemoradiation for Node-negative Small Cell Lung Cancer. Ann Surg. 2018 Dec;268(6):1105-1112. doi: 10.1097/SLA.0000000000002287.
- Background Yang CJ, Chan DY, Speicher PJ, Gulack BC, Tong BC, Hartwig MG, Kelsey CR, D'Amico TA, Berry MF, Harpole DH. Surgery Versus Optimal Medical Management for N1 Small Cell Lung Cancer. Ann Thorac Surg. 2017 Jun;103(6):1767-1772. doi: 10.1016/j.athoracsur.2017.01.043. Epub 2017 Apr 25.
- Background Faivre-Finn C, Snee M, Ashcroft L, Appel W, Barlesi F, Bhatnagar A, Bezjak A, Cardenal F, Fournel P, Harden S, Le Pechoux C, McMenemin R, Mohammed N, O'Brien M, Pantarotto J, Surmont V, Van Meerbeeck JP, Woll PJ, Lorigan P, Blackhall F; CONVERT Study Team. Concurrent once-daily versus twice-daily chemoradiotherapy in patients with limited-stage small-cell lung cancer (CONVERT): an open-label, phase 3, randomised, superiority trial. Lancet Oncol. 2017 Aug;18(8):1116-1125. doi: 10.1016/S1470-2045(17)30318-2. Epub 2017 Jun 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 1200 mg | Intravenous |
| Background | Carboplatin | Small molecule | 75 mg/m2 | Intravenous |
| Background | Etoposide | Small molecule | 100 mg/m2 | Intravenous |