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

• Register: EUCTR
• Last refreshed on: 30 June 2019
• Main ID: EUCTR2016-003503-64-IE
• Date of registration: 24/04/2017
• Prospective Registration: Yes
• Primary sponsor: Abbvie Deutschland GmbH & Co. KG
• Public title: A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)
• Date of first enrolment: 01/06/2017
• Target sample size: 740
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-003503-64
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Japan, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Russian Federation, Serbia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
• Histologically or cytologically confirmed ED SCLC (extensive stage disease at initial diagnosis)with ongoing clinical benefit (SD, PR, or CR per RECIST v1.1) 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 randomized 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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Extensive Stage Small Cell Lung Cancer (ED SCLC)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: Rovalpituzumab tesirine
Product Code: (SC16LD6.5)
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ROVALPITUZUMAB TESIRINE
CAS Number: 1613313-09-9
Current Sponsor code: SC16LD6.5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Product Name: dexamethasone
Pharmaceutical Form: Tablet
INN or Proposed INN: DEXAMETHASONE
Current Sponsor code: DEXAMETHASONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 8-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Progression-free survival (PFS) and overall survival (OS) in subjects with DLL3 high ED SCLC are the two primary efficacy endpoints.

Timepoint(s) of evaluation of this end point: PFS - From randomization to disease progression, or death of any cause, whichever occurs first.
OS - From randomization to death of any cause

Secondary Objective: To evaluate if rovalpituzumab tesirine improves progression-free survival by CRAC and overall survival in all randomized subjects compared to placebo.
To assess change in patient reported outcomes (PRO) with physical functioning as measured by the EORTC QLQ-C30 questionnaire in all randomized subjects compared to placebo.

Main Objective: To evaluate if rovalpituzumab tesirine improves progression-free survival, assessed by a Central Radiographic Assessment Committee (CRAC) according to RECIST v1.1, and overall survival in subjects with extensive-stage small cell lung cancer (ED SCLC) tumors with a high level of DLL3 expression (DLL3high) who have ongoing clinical benefit (SD, PR, or CR) following first line platinum-based chemotherapy (cisplatin or carboplatin plus irinotecan or etoposide) compared to placebo.

Secondary Outcome(s)

Secondary end point(s): - OS
-PFS per the CRAC based on RECIST v1.1
-EORTC QLQ-C30 physical functioning domain
- Objective response rate (ORR) per the CRAC and investigator assessment, respectively
- Clinical benefit rate (CBR) per the CRAC and investigator assessment, respectively
- Duration of response (DOR) per the CRAC and investigator assessment, respectively
Response assessment will be based on RECIST v1.1.
- Change from baseline in all PRO domains (except physical functioning) measured by EORTC QLQ-C30/ LC13 and EQ-5D-5L
- Safety endpoints will be summarized using data from the Safety set.

Timepoint(s) of evaluation of this end point: Disease progression will be defined as radiographic progression of disease by RECIST version 1.1.
PFS, ORR, CBR, DOR - From randomization to disease progression, or death of any cause, whichever occurs first.
Changes in PROs - From baseline (the assessment prior to first dose) to disease progression, or death of any cause, whichever occurs first.
Safety endpoints - From baseline to specified time points throughout the study.

Secondary ID(s)

M16-298

NCT03033511

2016-003503-64-EE

Source(s) of Monetary Support

AbbVie Inc

Ethics review

Status: Approved
Approval date:
Contact: