NCT05170581 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Gao S, Li N, Gao S, Xue Q, Ying J, Wang S, Tao X, Zhao J, Mao Y, Wang B, Shao K, Lei W, Wang D, Lv F, Zhao L, Zhang F, Zhao Z, Su K, Tan F, Gao Y, Sun N, Wu D, Yu Y, Ling Y, Wang Z, Duan C, Tang W, Zhang L, He S, Wu N, Wang J, He J
Neoadjuvant PD-1 inhibitor (Sintilimab) in NSCLC. J Thorac Oncol. 2020 May;15(5):816-826. doi: 10.1016/j.jtho.2020.01.017. Epub 2020 Feb 6.
Provencio M, Nadal E, Insa A, García-Campelo MR, Casal-Rubio J, Dómine M, Majem M, Rodríguez-Abreu D, Martínez-Martí A, De Castro Carpeño J, Cobo M, López Vivanco G, Del Barco E, Bernabé Caro R, Viñolas N, Barneto Aranda I, Viteri S, Pereira E, Royuela A, Casarrubios M, Salas Antón C, Parra ER, Wistuba I, Calvo V, Laza-Briviesca R, Romero A, Massuti B, Cruz-Bermúdez A
Neoadjuvant chemotherapy and nivolumab in resectable non-small-cell lung cancer (NADIM): an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2020 Nov;21(11):1413-1422. doi: 10.1016/S1470-2045(20)30453-8. Epub 2020 Sep 24.

Efficacy and Safety of Sintilimab Combined With Platinum-containing Chemotherapy in Neoadjuvant Treatment of Resectable Stage ⅡB～ⅢA Non-small Cell Lung Cancer

Details for clinical trial NCT05170581

Clinical trial NCT05170581 - References