Clinical trial · Interventional
RONICICLIB / Placebo in Combination With Chemotherapy in Small Cell Lung Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a study to investigate the potential clinical benefit of roniciclib when given in combination with chemotherapy Carboplatin / Etoposide or Cisplatin / Etoposide as first line treatment in patients with extensive disease small cell lung cancer. Approximately 140 patients will be randomized (1:1) to receive treatment with either roniciclib or placebo in combination with chemotherapy. Roniciclib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. The growth of the tumor may be decreased by preventing these specific proteins from functioning. By specifically targeting these proteins, roniciclib in combination with chemotherapy may stop cancer growth. The primary endpoint (the most meaningful result to be tracked) of this study is based on the progression free survival, i.e. the time the disease is not worsening. The aim is to show that the therapy with roniciclib in combination with chemotherapy prolongs the time the disease is not worsening in this patient population compared to patients receiving placebo in combination with chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Carcinoma | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Roniciclib (BAY1000394) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- BAY1000394
- description
- Roniciclib 5 mg bid 3 days on / 4 days off in combination with chemotherapy (carboplatin/etoposide or cisplatin/etoposide) during 6 cycles (21 days each) followed by monotherapy
- interventionNames
- Drug: Roniciclib (BAY1000394)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Matching placebo 3 days on / 4 days off in combination with chemotherapy (carboplatin/etoposide or cisplatin/etoposide) during 6 cycles (21 days each) followed by monotherapy
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Progression free survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female subjects aged ≥18 years (or country-specific legal age of maturity, if \>18 years) * Histologically or cytologically confirmed (extensive-stage disease) ED SCLC (small cell lung cancer) * 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 Exclusion Criteria: * Prior systemic anticancer therapy for SCLC (including previous therapy with a cyclin-dependent kinase \[CDK\] inhibitor)
References
Publications (1)
- DERIVEDReck M, Horn L, Novello S, Barlesi F, Albert I, Juhasz E, Kowalski D, Robinet G, Cadranel J, Bidoli P, Chung J, Fritsch A, Drews U, Wagner A, Govindan R. Phase II Study of Roniciclib in Combination with Cisplatin/Etoposide or Carboplatin/Etoposide as First-Line Therapy in Patients with Extensive-Disease Small Cell Lung Cancer. J Thorac Oncol. 2019 Apr;14(4):701-711. doi: 10.1016/j.jtho.2019.01.010. Epub 2019 Jan 21. PMID 30677506