A randomized, double-blind, placebo-controlled, phase III study evaluating the efficacy and safety of canakinumab in combination with docetaxel versus placebo in combination with docetaxel in subjects with non-small cell lung cancer (NSCLC) previously treated with PD-(L)1 inhibitors and platinum-based chemotherapy (CANOPY-2) -

OVARTIS PHARMA AG0 个研究点目标入组 245 人开始时间: 2021年9月3日最近更新: 2021年9月13日

适应症

试验速览

暂无简介。

•The main inclusion criteria are listed below. Other inclusion criteria, defined in the protocol, may apply.
•3.Histologically confirmed locally advanced/metastatic (stage IIIBIV) NSCLC.
•4.Subject has received one prior platinum-based chemotherapy and one prior PD-(L)1 inhibitor therapy for locally advanced or metastatic disease.
•5.Subject with ECOG performance status (PS) of 0 or 1.
•6.Subject with at least 1 evaluable (measurable or non measurable) lesion by RECIST 1.1 in solid tumors criteria.
•7.Serum lipase = 1.5 x ULN.
•8.Creatinine clearance = 60 mL/ min by calculation using Cockcroft- Gault formula.
•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 135
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 110

•The main exclusion criteria are listed below. Other exclusion criteria, defined in the protocol, may apply. 1.Subject who previously received docetaxel, canakinumab (or another IL-1ß inhibitor), or any systemic therapy for their locally advanced or metastatic NSCLC other than one platinum-based chemotherapy and one prior PD-(L)1 inhibitor.
•2.Subject with EGFR or ALK positive tumor.
•2.Subjects with pure squamous cell histology that are known to have EGFR/ ALK sensitizing mutations are excluded.
•2.Subjects with known BRAF V600 mutation or ROS1 rearrangement will be excluded if required by local guidelines.
•3.History of severe hypersensitivity reaction to monoclonal antibodies, taxanes or excipients of docetaxel or canakinumab.
•6.Subject with suspected or proven immunocompromised state or infections, including evidence of active or latent tuberculosis (TB) as determined by locally approved screening methods. If the results of the screening per local treatment guidelines or clinical practice require treatment, then the patient is not eligible.
•12.Subject with history of interstitial lung disease or pneumonitis grade
•18.Participation in a prior investigational study within 30 days prior to enrollment or within 5-half lives of the investigational product (other than chemotherapy or checkpoint inhibitors), whichever is longer or those who are expected to receive any other investigational drug or device the conduct of the study.

发起方