Feasibility and Safety Study of Nivolumab With Irinotecan for Small Cell Lung Cancer

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04173325
• Other study ID #: GCC-20-009
• Status: Terminated
• Phase: Phase 1
• Start date: January 6, 2020
• Est. completion date: May 26, 2022

Study information

• Verified date: June 2022
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Carcinoma
• Small-cell Lung Cancer

Intervention

Drug:
• Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]
PD-1 inhibitor approved by the US FDA for treatment of patients with lung cancer.
• Irinotecan Injection [Camptosar]
Chemotherapy drug currently FDA approved for treatment of multiple tumors, including small cell lung cancer.

Locations

Country	Name	City	State
United States	Georgia Cancer Center at AU Medical Center	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

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.