Health Condition 1: null- Small Cell Lung Cancer
Conditions
Interventions
Intervention1: Dinutuximab: Dinutuximab injection, for intravenous (IV) use
Control Intervention1: Irinotecan
: Irinotecan injection, IV infusion
Control Intervention2: Topotecan: Topotecan for inje
Sponsors
United Therapeutics
Eligibility
Inclusion criteria
Inclusion criteria: 1.Have histologically or cytologically confirmed SCLC (undifferentiated small-cell carcinoma arising in or consistent with lung cancer origin). 2.Documented relapse or disease progression during or after first-line platinum-based therapy (subjects refractory to initial platinum-based therapy are eligible). 3.Have no curative therapy available. 4.Have a life expectancy of at least 12 weeks. 5.Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6.Have adequate bone marrow and hepatic function. 7.Have calculated creatinine clearance (CrCL) >=30 mL/minute or serum creatinine 8.Women of reproductive potential must not be pregnant or breastfeeding and have a negative urine or serum pregnancy test obtained within 7 days prior to the first dose of study treatment. 9.Subjects must agree to consistently use 2 forms of highly effective contraception/birth control between signing of the informed consent and 60 days after the last study drug administration.
Exclusion criteria
Exclusion criteria: 1.Candidate for re-treatment with original platinum-based regimen as second-line therapy. 2.Prior treatment with irinotecan, topotecan, or dinutuximab. 3.Have active brain metastases. Subjects with brain metastases are allowed if they completed definitive brain therapy, are asymptomatic and radiologically stable, and if they are not currently receiving corticosteroids or radiation. 4.Have mixed small cell and non-small cell histologic features. 5.Have a previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta and Tis [carcinoma in situ]) or any previous cancer curatively treated 6.Have a history or current evidence of uncontrolled cardiovascular disease. 7.Have had a major surgery or significant trauma within 4 weeks of enrollment (Part 1) or randomization (Part 2). 8.Have had organ allograft or hematopoietic transplantation. 9.Have a history of hypersensitivity to any study drugs or their excipients, or intolerance to hydration due to preexisting pulmonary or cardiac impairment, or intolerance to opioid pain medications, or a history of severe hypersensitivity to any other antigen. 10.Have a history or current evidence of human immunodeficiency virus (HIV) infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS)Timepoint: [Time Frame: Up to approximately 2.5 years] | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) Objective response rate (ORR) Clinical benefit rate (CBR) Area under the concentration versus time curve (AUC) of dinutuximab Maximum concentration (Cmax) of dinutuximab Halt-life (t1/2) of dinutuximab Clearance (CL) of dinutuximab Incidence of adverse events Incidence of toxicitiesTimepoint: 1. Up to approximately 2.5 years 2. Up to approximately 2.5 years 3. Up to approximately 2.5 years 4. Approximately 4 months 5. Approximately 4 months 6. Approximately 4 months 7. Approximately 4 months 8. Up to approximately 2.5 years 9. Up to approximately 2.5 years | — |
Countries
Australia, Bulgaria, Canada, France, Georgia, Germany, Hong Kong, Hungary, India, Italy, Lithuania, Malaysia, Philippines, Poland, Republic of Korea, Romania, Russian Federation, Spain, Taiwan, Thailand, Ukraine, United Kingdom, United States of America
Contacts
Public ContactLokesh Chaudhari
United Therapeutics
Outcome results
None listed