A randomized, double blind, placebo-controlled, multicenter phase II study to evaluate efficacy and safety of roniciclib in subjects with extensive-stage disease small cell lung cancer (SCLC) who are receiving cisplatin + etoposide or carboplatin + etoposide as first-line therapy - Randomized phase II study of roniciclib vs placebo in subjects receiving chemotherapy for SCLC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004198-28-BE

Enrollment

140

Registered

2014-04-14

Start date

2014-06-02

Completion date

Unknown

Last updated

2018-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

extensive-stage disease small cell lung cancer (ED SCLC)

Interventions

Product Name: CDK inhibitor Product Code: BAY1000394, 2.5 mg tablet Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Roniciclib Current Sponsor code: BAY 1000349 Other descriptive name: CD

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Male or female subjects aged =18 years (or country-specific legal age of maturity, if >18 years) • Histologically or cytologically confirmed ED SCLC • At least 1 solid tumor lesion measurable by computer tomography (CT) scan or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90

Exclusion criteria

Exclusion criteria: • Prior systemic anticancer therapy for SCLC (including previous therapy with a cyclin-dependent kinase [CDK] inhibitor)

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to compare roniciclib with placebo in addition to background treatment with chemotherapy (either cisplatin + etoposide or carboplatin + etoposide) in terms of progression free survival (PFS) in SCLC patients. ;Secondary Objective: Additional efficacy parameters will be assessed as secondary objectives. Additional objectives of this study are to assess: • Safety • Patient reported outcomes (PROs) • Pharmacokinetics • Biomarker profile ;Primary end point(s): Progression free survival (PFS) as assessed by the investigator;Timepoint(s) of evaluation of this end point: PFS - every 6 weeks until end of treatment visit	—

Measure

Time frame

Main Objective: The primary objective is to compare roniciclib with placebo in addition to background treatment with chemotherapy (either cisplatin + etoposide or carboplatin + etoposide) in terms of progression free survival (PFS) in SCLC patients. ;Secondary Objective: Additional efficacy parameters will be assessed as secondary objectives. Additional objectives of this study are to assess: • Safety • Patient reported outcomes (PROs) • Pharmacokinetics • Biomarker profile ;Primary end point(s): Progression free survival (PFS) as assessed by the investigator;Timepoint(s) of evaluation of this end point: PFS - every 6 weeks until end of treatment visit

—

Secondary

Measure	Time frame
Secondary end point(s): - Overall survival (OS) - Time to progression (TTP) as assessed by the investigator - Objective response rate (ORR) as assessed by the investigator;Timepoint(s) of evaluation of this end point: - OS - when event occurs - TTP - every 6 weeks until end of treatment visit - ORR - every 6 weeks until end of treatment visit	—

Countries

Belgium, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Poland, United States

Contacts

Public ContactClinical Trial Contact

Bayer Healthcare AG

clinical-trials-contact@bayerhealthcare.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026