E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Extensive-stage Small Cell Lung Cancer |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10041068 |
E.1.2 | Term | Small cell lung cancer extensive stage |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- To assess the safety and tolerability for participants randomized to BMS-986012 in combination with carboplatin, etoposide, and nivolumab for 4 cycles (induction) followed by BMS-986012 and nivolumab maintenance (Arm A) vs those randomized to carboplatin, etoposide, and nivolumab for 4 cycles (induction) followed by nivolumab maintenance (Arm B).
- To compare the PFS as assessed by BICR of participants treated in the combination induction and maintenance therapies of Arms A and B described above. |
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E.2.2 | Secondary objectives of the trial |
- To estimate the PFSR at 6 and 12 months in each treatment arm, based on PFS by RECIST v1.1 as assessed by BICR. - To compare PFS as assessed by investigator of participants treated in the combination induction and maintenance therapies of Arms A and B described above. - To estimate the PFSR at 6 and 12 months in each treatment arm based on PFS by RECIST v1.1 assessed by investigator. - To estimate the ORR, TTR, and DOR by RECIST v1.1 criteria by BICR and by investigator. - To assess OS of Arm A and Arm B and estimate OSR at 12 and 24 months by treatment arm. - To characterize the immunogenicity of BMS-986012 in combination with carboplatin, etoposide, and nivolumab in Arm A. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 - At least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (Response Evaluation Criteria in Solid Tumors (RECIST) v1.1) criteria - Adequate hematologic and end organ function - Must agree to follow specific methods of contraception, if applicable |
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E.4 | Principal exclusion criteria |
- Women who are pregnant or breastfeeding - Paraneoplastic autoimmune syndrome requiring systemic treatment - History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan - Grade ≥ 2 peripheral sensory neuropathy at study entry - Significant uncontrolled cardiovascular disease - Active, known or suspected autoimmune disease or inflammatory disorder |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Incidence of adverse events (AEs) 2. Incidence of serious adverse events (SAEs) 3. Incidence of AEs leading to discontinuation 4. Incidence of deaths 5. Progression-free survival (PFS) by blinded independent central review (BICR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1: Up to 2 years and 100 days 2-4: Up to 2 years and 128 days 5: Up to 2 years |
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E.5.2 | Secondary end point(s) |
1. Progression-free survival rate (PFSR) [PFS by BICR based on RECIST v1.1 criteria] 2. PFS by investigator based on RECIST v1.1 criteria 3. PFSR at 6 and 12 months. PFS by investigator based on RECIST v1.1 criteria. 4. Objective response rate (ORR) based on RECIST v1.1 criteria 5. Time to response (TTR) based on RECIST v1.1 criteria 6. Duration of response (DOR) based on RECIST v1.1 criteria 7. Overall survival (OS) 8. Overall survival rate (OSR) 9. Immunogenicity of BMS-986012 measured by assessment of the presence of specific anti-drug antibodies (ADAs) to BMS-986012 (i.e. incidence of positive ADAs) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1, 3: 6 and 12 months 2, 4-6, 9-15: Up to 2 years 7, 8: Up to 3 years |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 24 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Canada |
Japan |
United States |
Belgium |
France |
Germany |
Greece |
Italy |
Netherlands |
Poland |
Romania |
Spain |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of trial is defined as the last visit or scheduled procedure for the last participant. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 25 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 21 |