NCT04610658

Immune Checkpoint Inhibition With Lurbinectedin Relapsed/Recurrent SCLC

Activity and Enhancement of Immune Checkpoint Inhibition With Lurbinectedin in Relapsed/Recurrent Small Cell Lung Cancer (SCLC)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, phase I/II trial to determine the Maximum Tolerated Dose (MTD), Recommended Phase II Dose (RP2D), and the safety and efficacy of the combination of nivolumab-ipilimumab plus lurbinectedin in patients with relapsed/recurrent small cell lung cancer after progression with first-line, platinum-based chemotherapy

Detailed description

Study was originally designed as a Phase I/II but was terminated during the Phase I portion due to dose limiting toxicities.

Conditions

• Small-cell Lung Cancer
• Relapsed Small Cell Lung Cancer
• Recurrent Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	Participants will receive 1 mg/kg Nivolumab on Day 1 of each treatment cycle for 4 cycles (induction immunotherapy). After 4 treatment cycles, Nivolumab will be continued at a flat dose of 360 mg.
DRUG	Ipilimumab	Participants will receive 3mg/kg Ipilimumab on Day 1 of each treatment cycle for 4 cycles (induction immunotherapy). After 4 cycles, Ipilimumab will be discontinued.
DRUG	Lurbinectedin	Participants will be treated at 1 of 3 dose levels of Lurbinectedin, beginning at 1.5 mg/m\^2 and increasing to 3.2 mg/m\^2 or the Maximum Tolerated Dose (MTD)

Timeline

• Start date: 2020-11-23
• Primary completion: 2023-03-24
• Completion: 2023-03-24
• First posted: 2020-10-30
• Last updated: 2024-04-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study