non-small cell lung cancer
Conditions
Interventions
Treatment with docetaxel monotherapy or docetaxel in combination with
GSK3359609.
Sponsors
GlaxoSmithKline
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival (randomization to death). | — |
Secondary
| Measure | Time frame |
|---|---|
| Milestone survival rate month 12 and 18. Complete or partial response, stable disease, disease progression (CR or PR, SD, PD). Overall response rate (ORR), progression free survival (PFS), Duration of response (DoR). (Serious) adverse events. PK parameters. | — |
Countries
Netherlands
Outcome results
None listed