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Immune Checkpoint Inhibition With Lurbinectedin Relapsed/Recurrent SCLC

NCT04610658 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-04-02

No results posted yet for this study

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

Conditions

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

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Alberto A Chiappori, MD · Moffitt Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-23
Primary Completion
2023-03-24
Completion
2023-03-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04610658 on ClinicalTrials.gov