Small Cell Lung CarcinomaPhase 2CONCEPT-SCLCNCT02161419
RONICICLIB / Placebo in Combination With Chemotherapy in Small Cell Lung Cancer
A Phase 2 study testing Roniciclib (BAY1000394) in people with Small Cell Lung Carcinoma, run by Bayer at 32 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Carcinoma
- What is being tested?
- Roniciclib (BAY1000394)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 32 sitesin 9 countries
- Study dates
- 30 Jul 2014to 25 May 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prior systemic anticancer therapy for SCLC (including previous therapy with a cyclin-dependent kinase [CDK] inhibitor)
Trial locations and contacts
32 sites in 9 countries.
32 sites in 9 countries
United States7 sites
Study site
Boca Raton, Florida, 33486
Study site
Charleston, South Carolina, 29425
Study site
Hershey, Pennsylvania, 17033
Study site
Nashville, Tennessee, 37232
Study site
Pittsburgh, Pennsylvania, 15232
Study site
Port Saint Lucie, Florida, 34952
Study site
St Louis, Missouri, 63110-1093
France4 sites
Study site
Brest, 29285
Study site
Lille, 59020
Study site
Marseille, 13915
Study site
Paris, 75020
Germany4 sites
Study site
Essen, North Rhine-Westphalia, 45147
Study site
Großhansdorf, 22927
Study site
Heidelberg, Baden-Wurttemberg, 69126
Study site
Oldenburg, Lower Saxony, 26121
Italy4 sites
Study site
Genoa, Liguria, 16132
Study site
Monza-Brianza, Lombardy, 20900
Study site
Sondrio, Lombardy, 23035
Study site
Turin, Piedmont, 10043
Hungary3 sites
Study site
Budapest, 1121
Study site
Mátraháza, 3233
Study site
Törökbálint, 2045
Poland3 sites
Study site
Gdansk, 80-952
Study site
Szczecin-Zdunowo, 70-891
Study site
Warsaw, 02-781
South Korea3 sites
Study site
Seongnam-si, Gyeonggido, 463-707
Study site
Seoul, 05505
Study site
Seoul, 120-752
Japan2 sites
Study site
Bunkyo, Tokyo, 113-8677
Study site
Kurume, Fukuoka, 830-0011
About this study
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
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
- Small Cell Lung Carcinoma
- Being tested
- Roniciclib (BAY1000394), Placebo
- Keywords
- Small Cell Lung Carcinoma,, First line, Extensive disease, Small cell lung cancer
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roniciclib (BAY1000394)Drug
Patients will receive roniciclib treatment as a 3 days on / 4 days schedule off with two 2.5 mg tablets twice daily for a total dose of 10.0 mg/day during 6 cycles (21 days each) of chemotherapy with Carboplatin/etoposide or Cisplatin/etoposide and continue thereafter as monotherapy until tumor progression, unacceptable toxicity, death, consent withdrawal, or withdrawal from the study.
PlaceboDrug
Patients will receive placebo treatment as a 3 days on / 4 days schedule off with two tablets twice daily during 6 cycles (21 days each) of chemotherapy with Carboplatin/etoposide or Cisplatin/etoposide and continue thereafter as monotherapy until tumor progression, unacceptable toxicity, death, consent withdrawal, or withdrawal from the study
| Study group | Role | What they receive |
|---|---|---|
| BAY1000394 | Active comparator | 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 Receives: Drug: Roniciclib (BAY1000394) |
| Placebo | Placebo comparator | 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Measured: Up to 17 months
Secondary outcomes (3)
Overall survival (OS)
Measured: Up to 17 months
Time to progression (TTP)
Measured: Up to 17 months
Overall response rate (ORR)
Measured: Up to 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study start30 Jul 2014
- Primary completion31 Dec 2015
- Study completion25 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161419
- Sponsor's protocol ID
- 14615
- Other IDs
- 2013-004198-28
- Acronym
- CONCEPT-SCLC
- Status last verified
- Jun 2018
- First submitted
- 10 Jun 2014
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30677506
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02161419
- Acronym / sponsor ID
- CONCEPT-SCLC / 14615
- Conditions
- Small Cell Lung Carcinoma
- Keywords
- Small Cell Lung Carcinoma,, First line, Extensive disease, Small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 142 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2014 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 25 May 2016 (actual)
- First posted
- 11 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAY1000394 | Active comparator | Drug: Roniciclib (BAY1000394)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 |
| Placebo | Placebo comparator | Drug: PlaceboMatching 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Prior systemic anticancer therapy for SCLC (including previous therapy with a cyclin-dependent kinase [CDK] inhibitor)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roniciclib (BAY1000394)Patients will receive roniciclib treatment as a 3 days on / 4 days schedule off with two 2.5 mg tablets twice daily for a total dose of 10.0 mg/day during 6 cycles (21 days each) of chemotherapy with Carboplatin/etoposide or Cisplatin/etoposide and continue thereafter as monotherapy until tumor progression, unacceptable toxicity, death, consent withdrawal, or withdrawal from the study. | Drug | BAY1000394 |
| PlaceboPatients will receive placebo treatment as a 3 days on / 4 days schedule off with two tablets twice daily during 6 cycles (21 days each) of chemotherapy with Carboplatin/etoposide or Cisplatin/etoposide and continue thereafter as monotherapy until tumor progression, unacceptable toxicity, death, consent withdrawal, or withdrawal from the study | Drug | Placebo |
Primary outcome
Progression free survival (PFS)
Time frame: Up to 17 months
3 secondary outcomes
Overall survival (OS)
Time frame: Up to 17 months
Time to progression (TTP)
Time frame: Up to 17 months
Overall response rate (ORR)
Time frame: Up to 17 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
- Derived from this study: PubMed 30677506Reck 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.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
32 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Roniciclib (BAY1000394) in people with Small Cell Lung Carcinoma, run by Bayer at 32 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, France, Germany, Italy, Hungary and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: Up to 17 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02161419, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2018.