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)
- Conditions
- lung cancer10029107non-small cell lung cancer
- Registration Number
- NL-OMON55684
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
• 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
3a-b.
• 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
effusions.
• Active infection requiring systemic therapy, known human immunodeficiency
virus infection, positive test for hepatitis B or hepatitis C.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method