A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)

Phase 1

• Conditions: Extensive Stage Small Cell Lung Cancer (ED SCLC); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-003503-64-GB
• Lead Sponsor: Abbvie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-25
• Study Completion: 2019-11-29
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 748

Inclusion Criteria

• Histologically or cytologically confirmed ED SCLC (extensive stage disease at initial diagnosis) with ongoing clinical benefit (SD, PR, or CR per RECIST v.1.1) following completion of 4 cycles of first-line platinum-based therapy (cisplatin or carboplatin in combination with etoposide or
irinotecan).
• Subject is eligible to be randomised at least 3 but no more than 9 weeks from Day 1 of the fourth cycle of first-line platinum-based chemotherapy.
• Participants with a history of central nervous system (CNS) metastases prior to the initiation of first-line platinum-based chemotherapy must have received definitive local treatment and have documentation of stable or improved CNS disease status
• Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
• Participants must have adequate bone marrow, renal and hepatic function

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 500

Exclusion Criteria

• Any prior systemic chemotherapy, small molecule inhibitors, immune checkpoint inhibitors, other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, T-cell or other cell-based or biologic therapies, or any other anti-cancer therapy than that described in inclusion criteria 3-5 for SCLC
• Any disease-directed radiotherapy (except, PCI, palliative
radiotherapy to a radiographically documented non-progressing lesion for symptom control, or pre-planned radiotherapy for CNS metastases present prior to start of first-line therapy and non-progressing) after last dose of first-line chemotherapy.
• Prior exposure to a pyrrolobenzodiazepine (PBD)- or indolinobenzodiazepine-based drug, prior participation in a rovalpituzumab tesirine clinical trial, or known hypersensitivity or other contraindications to rovalpituzumab tesirine or excipient contained in the drug formulation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified