A Phase II, Randomized, Open-label Platform Trial Utilizing a MastercProtocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants (study 205801) - study 205801 (ENTREE)

GlaxoSmithKline0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

Trial ended prematurely

•Male or female, age 18 years and above.
•Histologically or cytologically confirmed diagnosis of NSCLC (squamous or
•non-squamous).
•Documented disease progression during or after a maximum of 2 lines of
•systemic treatment for locally/regionally advanced recurrent, Stage IIIb/Stage
•IV or metastatic disease. For further details: see protocol section 6.1, item
•Measurable disease.
•ECOG performance status 0-1.
•Fresh tumor sample (preferred) or archival tumor tissue obtained at any time
•from the initial diagnosis to study.
•Not pregnant or postmenopausal females and females of non-reproductive
•potential or reproductive potential and agrees to follow a required
•contraceptive method. For further details: see protocol section 6.1, item 9 and
•appendix 6.
•Male subjects who agree to use one of the required methods of contraception
•and refrain from sperm donation. For further details: see protocol section 6.1,
•item 8 and appendix 6.

•Prior treatment with docetaxel, any of the investigational agents tested in
•this study, systemic approved or investigational treatment within 30 days,
•prior radiotherapy within 2 weeks. For further details: see protocol section
•6.2, item 1.
•Three or more lines of therapy for NSCLC, including patients with BRAF
•molecular alternations. Patients with known EGFR/ALK/ROS1 molecular alterations
•are excluded from participation.
•CNS metastases. Exception: see protocol section 6.2, item 4.
•Autoimmune disease (current en history) that has required systemic treatment
•within the last 2 years. Replacement therapy is not considered a form of
•systemic treatment. For further details: see protocol section 6.2, item 6-7.
•Live vaccine within 30 days.
•Within the past 6 months: acute diverticulitis, inflammatory bowel disease,
•intra-abdominal abscess, or gastrointestinal obstruction.
•History or evidence of cardiac and pulmonary abnormalities. For further
•details: see protocol section 6.2, item 11, 14.
•Within 6 months: uncontrolled symptomatic ascites or pleural or pericardial
•Active infection requiring systemic therapy, known human immunodeficiency
•virus infection, positive test for hepatitis B or hepatitis C.

发起方