2022-503007-22-00CompletedPhase 2
A Phase 2 Study of BMS-986315 and Nivolumab in Combination with Chemotherapy in Participants with First-line Stage IV or Recurrent NSCLC
A Randomized, Double-Blind, Phase II Study of BMS-986315 and Nivolumab in Combination with Chemotherapy Versus Nivolumab in Combination with Chemotherapy as First-line Treatment for Participants with Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 1 Feb 2024
Brief summary (registry, in English)
Part 1: Safety Lead-in Assess the safety of BMS-986315 administered in combination with nivolumab and histology-based platinum doublet chemotherapy (PDCT). Part 2: Primary Compare the anti-tumor activity, specifically the objective response rate (ORR) of BMS-986315 and nivolumab in combination with PDCT versus nivolumab and PDCT.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 95 (actual)
- First submitted
- 15 Sept 2023
- Start date
- 17 Feb 2024
- Lead sponsor
- Bristol-Myers Squibb Services Unlimited Company
- Diseases
- Lung cancer
- EU CT number
- 2022-503007-22-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 95
- 24 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- Male and female participants must be ≥ 18 years of age or local age of majority at the time of signing the informed consent. Participants must have NSCLC with Stage IV or recurrent disease following multimodal therapy for locally advanced disease. Study treatment must be first-line therapy for Stage IV or recurrent disease. Participants in all parts of the study must have measurable disease per RECIST v1.1; an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; and a life expectancy of at least 3 months at the time of first dose.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (24)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Catala d'Oncologia | Badalona | Spain | Completed |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Completed |
| Institut Catala D'oncologia | L'Hospitalet de Llobregat | Spain | Completed |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | Spain | Completed |
| Hospital Universitario Regional de Málaga | Málaga | Spain | Completed |
| Hospital Clinico Universitario Lozano Blesa | Zaragoza | Spain | Completed |
| Centre Hospitalier Universitaire De Caen Normandie | Caen Cedex 9 | France | Completed |
| Centre Hospitalier Universitaire Grenoble Alpes | Grenoble Cedex 9 | France | Completed |
| Institut Curie | Paris | France | Completed |
| Centre Hospitalier de Saint-Quentin | Saint-Quentin | France | Completed |
| Institut De Cancerologie De L Ouest | St Herblain | France | Completed |
| Ospedale San Raffaele S.r.l. | Milan | Italy | Completed |
| Azienda Ospedaliero Universitaria Parma | Parma | Italy | Completed |
| Hospital Santa Maria Della Misericordia | Perugia | Italy | Completed |
| Fondazione Policlinico Universitario Campus Bio-Medico | Rome | Italy | Completed |
| I.F.O. Istituti Fisioterapici Ospitalieri | Rome | Italy | Completed |
| Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok | Poland | Completed |
| Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o. | Cracow | Poland | Completed |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | Completed |
| Instytut Centrum Zdrowia Matki Polki | Lodz | Poland | Completed |
| Med Polonia Sp z o.o. | Poznan | Poland | Completed |
| Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca | Cluj-Napoca | Romania | Completed |
| Medisprof S.R.L. | Cluj-Napoca | Romania | Completed |
| Centrul De Oncologie SF Nectarie S.R.L. | Craiova | Romania | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.