Clinical trial NCT02161419: RONICICLIB / Placebo in Combination With Chemotherapy in Small Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Small Cell Lung Carcinoma
Keywords: Small Cell Lung Carcinoma,
First line
Extensive disease
Small cell lung cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-06-11
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: Up to 17 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Up to 17 months
measure: Time to progression (TTP)
timeFrame: Up to 17 months
measure: Overall response rate (ORR)
timeFrame: Up to 17 months
Other outcomes:
Locations:
city: Boca Raton
country: United States
state: Florida
city: Port Saint Lucie
country: United States
state: Florida
city: Saint Louis
country: United States
state: Missouri
city: Hershey
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Bruxelles - Brussel
country: Belgium
city: Liege
country: Belgium
city: Brest
country: France
city: Lille Cedex
country: France
city: Marseille Cedex 20
country: France
city: Paris
country: France
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Oldenburg
country: Germany
state: Niedersachsen
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Grosshansdorf
country: Germany
city: Budapest
country: Hungary
city: Matrahaza
country: Hungary
city: Torokbalint
country: Hungary
city: Genova
country: Italy
state: Liguria
city: Monza-Brianza
country: Italy
state: Lombardia
city: Sondrio
country: Italy
state: Lombardia
city: Torino
country: Italy
state: Piemonte
city: Kurume
country: Japan
state: Fukuoka
city: Bunkyo
country: Japan
state: Tokyo
city: Seongnam-si
country: Korea, Republic of
state: Gyeonggido
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Gdansk
country: Poland
city: Szczecin-Zdunowo
country: Poland
city: Warszawa
country: Poland
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Reck 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.