A Phase 3, Randomized, Open Label Study to Compare Nivolumab plus Concurrent Chemoradiotherapy (CCRT) followed by Nivolumab plus Ipilimumab or Nivolumab plus CCRT Followed by Nivolumab vs CCRT followed by Durvalumab in Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) - CheckMate73

Bristol-Myers Squibb International Corporation0 个研究点目标入组 1,400 人开始时间: 2019年8月9日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•- Eastern Cooperative Oncology Group (ECOG) performance status =1
•- Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4 N0-3 M0) histologically-confirmed NSCLC, according to 8th TNM classification
•- Newly diagnosed and treatment-naïve, with no prior local or systemic anticancer therapy given as primary therapy for locally advanced disease
•Other protocol defined inclusion criteria could apply
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 770
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 630

•- Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator would preclude the patient from adhering to the protocol or would increase the risk associated with study participation
•- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti- CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
•- Active infection requiring systemic therapy within 14 days prior to randomization
•- Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
•- Participants with an active, known or suspected autoimmune disease or a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of randomization.
•- History of organ or tissue transplant that requires systemic use of immune suppressive agents.
•- Clinical evidence of hearing loss
•- Prior thoracic radiotherapy
•Other protocol defined exclusion criteria could apply

发起方