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

Sponsor
Antonio Calles Blanco
Study ID
NCT04358237
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Small Cell Lung Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lurbinectedin — DRUG
    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.
  • Pembrolizumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 21, 2020
Status verified
May 2025
Primary completion
Sep 30, 2023
Completion
May 20, 2025

Study Design

Enrollment
28 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: lurbinectedin (PM01183) + pembrolizumab
    During the phase I stage, patients will start receiving pembrolizumab at a fixed dose of 200 mg as a 30-min intravenous (IV) infusion followed by lurbinectedin at a starting dose of 2.4 mg/m2 as a 1-h IV infusion on Day 1, both every 3 weeks (Q3W). Lurbinectedin dose will be escalated from the starting dose in successive cohorts of patients, with a pre-established fixed dose increase (in mg/m2) of approximately 30%. During the phase II stage, patients will receive pembrolizumab at a fixed dose of 200 mg as a 30-min IV infusion followed by lurbinectedin as a 1-h IV infusion on Day 1 Q3W at the redommended dose (RD) determined during the phase I stage. A cycle is defined as an interval of 3 weeks. No dose escalation will be allowed during the phase II stage.

Primary Outcome Measure

Phase I: Maximum tolerated dose (MTD) and recommended phase II dose (RD) of lurbinectedin in combination with pembrolizumab in patients with relapsed SCLC. [ Time Frame: 12 months ]

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