Small-cell Lung Cancer Clinical Trial
Official title:
Phase I Feasibility and Safety Study of Nivolumab in Combination With Irinotecan in Relapsed or Refractory Small Cell Lung Cancer (SCLC) Followed by Maintenance Nivolumab
Verified date | June 2022 |
Source | Augusta University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 10 |
Est. completion date | May 26, 2022 |
Est. primary completion date | May 26, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Georgia Cancer Center at AU Medical Center | Augusta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Augusta University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate the frequency and severity of adverse events in patients with small cell lung cancer after receiving nivolumab plus irinotecan followed by nivolumab maintenance. | CTCAE v.4.0. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. | through study completion, an average of 1 year | |
Secondary | Overall response rate | Tumor response evaluation with RECIST | through study completion, an average of 1 year | |
Secondary | Progression-free survival (PFS) | PFS as measured from start of therapy till disease progression. | through study completion, an average of 1 year | |
Secondary | Overall survival (OS) | OS as measured from start of therapy till date of death or last follow up assessment. | through study completion, an average of 1 year. |
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