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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001692-67 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm 1 | Experimental | BMS-986012/Cisplatin/Etoposide |
|
| Experimental Arm 2 | Experimental | BMS-986012/Carboplatin/Etoposide |
|
| Experimental Arm 3A | Experimental | BMS-986012/Platinum/Etoposide |
|
| Active Comparator Arm 3B | Active Comparator | Platinum/Etoposide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986012 | Drug |
| ||
| Cisplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Cycle 1, Day 1 up to approximately 26 months. | |
| Number of participants with serious adverse events (SAEs ) | Date of enrollment up to approximately 26 months. | |
| Discontinuations due to AEs | Cycle 1, Day 1 up to approximately 26 months. | |
| Number of participants who died due to AEs | Cycle 1, Day 1 up to approximately 26 months. | |
| Number of participants with laboratory toxicity grade shift from baseline | Cycle 1, Day 1 up to approximately 26 months. | |
| Progression Free Survival | From date of first dose or randomization until date of confirmed disease progression, up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum concentration(Cmax) | Cycle 1 Day 1 up to 60 days after last dose | |
| Time of maximum observed serum concentration(Tmax) | Cycle 1 Day 1 up to 60 days after last dose | |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0002 | Barcelona | 08035 | Spain | |||
| Local Institution - 0004 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D005047 | Etoposide |
| D010984 | Platinum |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Drug |
|
| Etoposide | Drug |
|
| Platinum | Drug |
|
| Carboplatin | Drug |
|
| Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration(AUC(0-T)) |
| Cycle 1 Day 1 up to 60 days after last dose |
| Observed serum concentration at the end of a dosing interval(Ctau) | Cycle 1 Day 1 up to 60 days after last dose |
| Area under the concentration-time curve in 1 dosing interval(AUC(TAU)) | Cycle 1 Day 1 up to 60 days after last dose |
| Characterization of Immunogenicity | Anti-Drug Antibodies | Cycle 1 Day 1 up to 60 days after last dose |
| Madrid |
| 28041 |
| Spain |
| Local Institution - 0003 | Majadahonda - Madrid | 28222 | Spain |
| Local Institution - 0010 | Málaga | 29010 | Spain |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011034 |
| Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D028561 | Transition Elements |
| D008670 | Metals |
| D056831 | Coordination Complexes |