Small-cell Lung Cancer, Small Cell Lung Carcinoma
Conditions
Keywords
Lung cancer, Relapsed lung cancer
Brief summary
This study will determine the frequency of adverse events (side effects) in patients with relapsed or refractory small cell lung cancer (SCLC) when given nivolumab and irinotecan together followed by nivolumab maintenance. This study will test the safety of the study treatments when given together and see what effect (good or bad) it has on participants and their cancer.
Interventions
PD-1 inhibitor approved by the US FDA for treatment of patients with lung cancer.
Chemotherapy drug currently FDA approved for treatment of multiple tumors, including small cell lung cancer.
Sponsors
Augusta University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed SCLC with known UGT1A genotype. * Patients who have received at least 1 prior platinum-based chemotherapy. * Life expectancy of 3 months or more. * Measurable disease.
Exclusion criteria
* Patients with UGT1A polymorphism. * Currently receiving chemotherapy. * Pregnant and nursing women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the frequency and severity of adverse events in patients with small cell lung cancer after receiving nivolumab plus irinotecan followed by nivolumab maintenance. | through study completion, an average of 1 year | CTCAE v.4.0. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate | through study completion, an average of 1 year | Tumor response evaluation with RECIST |
| Progression-free survival (PFS) | through study completion, an average of 1 year | PFS as measured from start of therapy till disease progression. |
| Overall survival (OS) | through study completion, an average of 1 year. | OS as measured from start of therapy till date of death or last follow up assessment. |
Countries
United States
Outcome results
None listed