Small Cell Lung CancerPhase 1NCT02815592
Trial of BMS-986012 in Combination With Platinum and Etoposide
A Phase 1 study testing BMS-986012, Cisplatin and Etoposide in people with Small Cell Lung Cancer, run by Bristol-Myers Squibb at 4 sites in Spain.
Trial summary
The purpose of this this study is to administer BMS-986012 in Combination with Platinum and Etoposide as First-line Therapy in Extensive 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 Cancer
- What is being tested?
- BMS-986012, Cisplatin and Etoposide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesSpain
- Study dates
- 28 Nov 2016to 6 Aug 2024
- Phase
- Phase 1
- 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 and Females 18 years of age or older
- Pulmonary SCLC documented by histology or cytology
- Extensive disease (Stage IV) SCLC
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Who cannot join
- Prior systemic therapy for lung cancer
- Symptomatic brain metastases
- Grade 2 peripheral neuropathy
- Active or chronic infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV
- Other active malignancies or prior malignancy within 2 years
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Local Institution - 0002
Barcelona, 08035
Local Institution - 0004
Madrid, 28041
Local Institution - 0003
Majadahonda - Madrid, 28222
Local Institution - 0010
Málaga, 29010
About this study
Official title: A Phase 1/2 Randomized Trial of BMS-986012 in Combination With Platinum and Etoposide as First-line Therapy in Extensive-Stage Small Cell Lung Cancer
The purpose of this this study is to administer BMS-986012 in Combination with Platinum and Etoposide as First-line Therapy in Extensive Small Cell Lung Cancer.
- Conditions
- Small Cell Lung Cancer
- Being tested
- BMS-986012, Cisplatin, Etoposide, Platinum, Carboplatin
- 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.
BMS-986012Drug
CisplatinDrug
EtoposideDrug
PlatinumDrug
CarboplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm 1 | Experimental | BMS-986012/Cisplatin/Etoposide Receives: Drug: BMS-986012; Drug: Cisplatin; Drug: Etoposide |
| Experimental Arm 2 | Experimental | BMS-986012/Carboplatin/Etoposide Receives: Drug: BMS-986012; Drug: Etoposide; Drug: Carboplatin |
| Experimental Arm 3A | Experimental | BMS-986012/Platinum/Etoposide Receives: Drug: BMS-986012; Drug: Etoposide; Drug: Platinum |
| Active Comparator Arm 3B | Active comparator | Platinum/Etoposide Receives: Drug: Etoposide; Drug: Platinum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
Measured: Cycle 1, Day 1 up to approximately 26 months.
Number of participants with serious adverse events (SAEs )
Measured: Date of enrollment up to approximately 26 months.
Discontinuations due to AEs
Measured: Cycle 1, Day 1 up to approximately 26 months.
Number of participants who died due to AEs
Measured: Cycle 1, Day 1 up to approximately 26 months.
Number of participants with laboratory toxicity grade shift from baseline
Measured: Cycle 1, Day 1 up to approximately 26 months.
Progression Free Survival
Measured: From date of first dose or randomization until date of confirmed disease progression, up to 2 years
Secondary outcomes (6)
Maximum observed serum concentration(Cmax)
Measured: Cycle 1 Day 1 up to 60 days after last dose
Time of maximum observed serum concentration(Tmax)
Measured: Cycle 1 Day 1 up to 60 days after last dose
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration(AUC(0-T))
Measured: Cycle 1 Day 1 up to 60 days after last dose
Observed serum concentration at the end of a dosing interval(Ctau)
Measured: Cycle 1 Day 1 up to 60 days after last dose
Area under the concentration-time curve in 1 dosing interval(AUC(TAU))
Measured: Cycle 1 Day 1 up to 60 days after last dose
Characterization of Immunogenicity
Anti-Drug Antibodies
Measured: Cycle 1 Day 1 up to 60 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study start28 Nov 2016
- Primary completion15 Dec 2019
- Study completion6 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815592
- Sponsor's protocol ID
- CA001-044
- Other IDs
- 2016-001692-67, 2016
- Status last verified
- Aug 2024
- First submitted
- 24 Jun 2016
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Randomized Trial of BMS-986012 in Combination With Platinum and Etoposide as First-line Therapy in Extensive-Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02815592
- Acronym / sponsor ID
- CA001-044
- Conditions
- Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2016 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 28 Jun 2016 (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.
The purpose of this this study is to administer BMS-986012 in Combination with Platinum and Etoposide as First-line Therapy in Extensive Small Cell Lung Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm 1 | Experimental | Drug: BMS-986012, Drug: Cisplatin, Drug: EtoposideBMS-986012/Cisplatin/Etoposide |
| Experimental Arm 2 | Experimental | Drug: BMS-986012, Drug: Etoposide, Drug: CarboplatinBMS-986012/Carboplatin/Etoposide |
| Experimental Arm 3A | Experimental | Drug: BMS-986012, Drug: Etoposide, Drug: PlatinumBMS-986012/Platinum/Etoposide |
| Active Comparator Arm 3B | Active comparator | Drug: Etoposide, Drug: PlatinumPlatinum/Etoposide |
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 and Females 18 years of age or older
- Pulmonary SCLC documented by histology or cytology
- Extensive disease (Stage IV) SCLC
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Key exclusion criteria (6 listed)
- Prior systemic therapy for lung cancer
- Symptomatic brain metastases
- Grade 2 peripheral neuropathy
- Active or chronic infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV
- Other active malignancies or prior malignancy within 2 years
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 |
|---|---|---|
| BMS-986012 | Drug | Experimental Arm 1, Experimental Arm 2, Experimental Arm 3A |
| Cisplatin | Drug | Experimental Arm 1 |
| Etoposide | Drug | Active Comparator Arm 3B, Experimental Arm 1, Experimental Arm 2, Experimental Arm 3A |
| Platinum | Drug | Active Comparator Arm 3B, Experimental Arm 3A |
| Carboplatin | Drug | Experimental Arm 2 |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Cycle 1, Day 1 up to approximately 26 months.
Number of participants with serious adverse events (SAEs )
Time frame: Date of enrollment up to approximately 26 months.
Discontinuations due to AEs
Time frame: Cycle 1, Day 1 up to approximately 26 months.
Number of participants who died due to AEs
Time frame: Cycle 1, Day 1 up to approximately 26 months.
Number of participants with laboratory toxicity grade shift from baseline
Time frame: Cycle 1, Day 1 up to approximately 26 months.
Progression Free Survival
Time frame: From date of first dose or randomization until date of confirmed disease progression, up to 2 years
6 secondary outcomes
Maximum observed serum concentration(Cmax)
Time frame: Cycle 1 Day 1 up to 60 days after last dose
Time of maximum observed serum concentration(Tmax)
Time frame: Cycle 1 Day 1 up to 60 days after last dose
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration(AUC(0-T))
Time frame: Cycle 1 Day 1 up to 60 days after last dose
Observed serum concentration at the end of a dosing interval(Ctau)
Time frame: Cycle 1 Day 1 up to 60 days after last dose
Area under the concentration-time curve in 1 dosing interval(AUC(TAU))
Time frame: Cycle 1 Day 1 up to 60 days after last dose
Characterization of Immunogenicity
Time frame: Cycle 1 Day 1 up to 60 days after last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink 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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986012, Cisplatin and Etoposide in people with Small Cell Lung Cancer, run by Bristol-Myers Squibb at 4 sites in Spain.
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 6 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: finished, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with adverse events (AEs) (time frame: Cycle 1, Day 1 up to approximately 26 months.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2024.