NCT03116971

Phase Ib/II Study of M3814 With Etoposide and Cisplatin in Small Cell Lung Cancer (SCLC) Extensive Disease (ED)

A Multicenter Study With an Open Label Phase Ib Part Followed by a Randomized, Placebo-controlled, Double-blind, Phase II Part to Evaluate Efficacy, Safety, Tolerability, and PK of M3814 in Combination With Etoposide and Cisplatin in Subjects With Treatment-naïve Small Cell Lung Cancer (SCLC) Extensive Disease (ED)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

M3814 is an investigational drug under evaluation for treatment of lung cancer. The purpose of the study was to assess the Safety and Efficacy of M3814 in combination with chemotherapy with SCLC ED.

Detailed description

The study was intended to be a phase I/II trial, but the study never moved forward to Phase II due to recruitment challenges.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	M3814	Participants received M3814 PiC or hot melt extrusion (HME) tablet orally once daily in combination with etoposide (intravenously) and cisplatin for 6 cycles with each cycle lasting 3 weeks (21 days).
DRUG	Cisplatin	Cisplatin 75 milligram per square meter (mg/m\^2) was administered over a 60-minute intravenous infusion on Day 1.
DRUG	Etoposide	Etoposide 100 mg/m\^2 over a 60 minute IV infusion on Days 1-3 was administered for 6 cycles with each cycle lasting 3 weeks (21 days).

Timeline

• Start date: 2017-05-25
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2017-04-17
• Last updated: 2020-09-16

Locations

80 sites across 13 countries: United States, Belgium, Bulgaria, Canada, Czechia, Denmark, Germany, Hungary, Italy, Poland, Romania, Spain, United Kingdom

Regulatory

• FDA-regulated drug study