A trial of BMS-986012 in combination with chemotherapy for small cell lung cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bristol Myers Squibb International Corporation

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

18 Oct 2016 → 6 Aug 2024

Decision date (initial)

2024-05-06

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Bristol-Myers Squibb International Corporation

External identifiers

EU CT number

2024-511824-15-00

EudraCT number

2016-001692-67

WHO UTN

U1111-1181-9439

ClinicalTrials.gov

NCT02815592

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacogenetic, Therapy, Pharmacogenomic, Safety, Efficacy, Others, Pharmacodynamic, Pharmacokinetic

-Part 1 and 2: To assess the safety, tolerability, and maximum tolerated dose (MTD) or maximum administered dose (MAAD) of BMS-986012
given in combination with 4 cycles of cisplatin/etoposide (Part 1) and carboplatin/etoposide (Part 2), and then continuing as BMS-986012 monotherapy until disease progression.
-Part 3: To compare the PFS of subjects randomized to receive BMS 986012 in combination with platinum and etoposide for 4 cycles and then continuing as BMS-986012 monotherapy until disease progression (Arm 3A) to that of subjects randomized to receive platinum and
etoposide alone (Arm 3B) in subjects with newly diagnosed extensive-stage SCLC.

Secondary objectives 2

1. To characterize the pharmacokinetics of BMS-986012
2. To characterize the immunogenicity of BMS-986012

Conditions and MedDRA coding

Extensive-Stage Small Cell Lung Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Pulmonary SCLC documented by histology or cytology
2. Extensive disease (Stage IV) Small Cell Lung Cancer
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
4. Male and Females 18 years of age or older

Exclusion criteria 5

1. Prior systemic therapy for lung cancer
2. Symptomatic brain metastases
3. Grade 2 peripheral neuropathy
4. Active or chronic infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
5. Other active malignancies or prior malignancy within 2 years

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 6

1. Number of participants with adverse events (AEs)
2. Number of participants with serious adverse events (SAEs)
3. Discontinuations due to AEs
4. Number of participants who died due to AEs
5. Number of participants with laboratory toxicity grade shift from baseline
6. Progression Free Survival

Secondary endpoints 6

1. Maximum observed serum concentration(Cmax)
2. Time of maximum observed serum concentration(Tmax)
3. Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration(AUC(0-T))
4. Observed serum concentration at the end of a dosing interval(Ctau)
5. Area under the concentration-time curve in 1 dosing interval(AUC(TAU))
6. Characterization of Immunogenicity

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol Myers Squibb International Corporation

Sponsor organisation

Bristol Myers Squibb International Corporation

Address

Terhulpsesteenweg 185

City

Watermaal-Bosvoorde

Postcode

1170

Country

Belgium

Scientific contact point

Organisation

Bristol Myers Squibb International Corporation

Contact name

GSM-CT

Public contact point

Organisation

Bristol Myers Squibb International Corporation

Contact name

GSM-CT

Third parties 2

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications