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Lurbinectedin (PM01183) Combined With Pembrolizumab in Small Cell Lung Cancer.

NCT04358237 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-06-04

No results posted yet for this study

Summary

This is a prospective, open-label, uncontrolled and multicenter phase I/II study of PM01183 in combination with pembrolizumab in patients with relapsed small cell lung cancer (SCLC).

The study will be divided into two stages:

* A dose-ranging phase I stage with escalating doses of PM01183 in combination with a fixed dose of pembrolizumab, followed by:
* A non-randomized phase II stage as an expansion study at the recommended dose (RD) determined during the phase I stage.

The phase I stage will focus on the selection of the RD based on safety/tolerability, while the phase II stage will assess the overall response rate (ORR) and clinical response.

Conditions

  • Small Cell Lung Carcinoma

Interventions

DRUG

Lurbinectedin

Lurbinectedin will be presented as a lyophilized powder for concentrate for solution for infusion in 4-mg vials. Before use, the 4-mg vial will be reconstituted with 8 mL of sterile water for injection, to give a solution containing 0.5 mg/mL of PM01183. For administration to patients as IV infusion, reconstituted vials will be diluted with glucose 50 mg/mL (5%) or sodium chloride 9 mg/mL (0.9%) solution for infusion. PM01183 will be administered as a 1 hour IV infusion Q3W, in a minimum volume of 100 mL of solution for infusion (either 5% glucose or 0.9% sodium chloride), or a minimum volume of 250 mL if through a peripheral line, always at a fixed rate and through a pump device.

DRUG

Pembrolizumab

Pembrolizumab will be supplied as a solution for infusion in a single-use vial. Each vial contains 100 mg of MK3475 (pembrolizumab) in 4 ml of solution. Pembrolizumab 200 mg will be administered as a 30 minute IV infusion Q3W.

Sponsors & Collaborators

  • MedSIR

    collaborator OTHER

  • PharmaMar

    collaborator INDUSTRY

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Antonio Calles Blanco

    lead OTHER

Principal Investigators

  • Antonio Calles · Hospital Gregorio Marañon

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-21
Primary Completion
2023-09-30
Completion
2025-05-20

Countries

  • Spain

Study Locations

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Entities

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 NCT04358237 on ClinicalTrials.gov