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A Safety, Tolerability and Preliminary Efficacy Evaluation of CC-90011 Given in Combination With Cisplatin and Etoposide in Subjects With First Line, Extensive Stage Small Cell Lung Cancer

NCT03850067 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-08-26

No results posted yet for this study

Summary

CC-90011-SCLC-001 is a multicenter, Phase 1b, open-label, dose finding study to assess the safety, tolerability, and preliminary efficacy of CC-90011 given concurrently and sequentially to standard of care platinum-based, cisplatin and etoposide, carboplatin and etoposide and/or etoposide and Nivolumab to subjects with first line ES SCLC.

The dose finding part of the study will explore escalating oral doses of CC-90011 in combination with cisplatin, etoposide and/or carboplatin with or without Nivolumab (chemotherapy), to determine the maximum tolerated dose of CC- 90011 in combination with chemotherapy with or without Nivolumab to subjects with first line ES SCLC.

Conditions

  • Small Cell Lung Carcinoma

Interventions

DRUG

CC-90011

CC-90011

DRUG

Cisplatin

Cisplatin

DRUG

Carboplatin

Carboplatin

DRUG

Etoposide

Etoposide

DRUG

Nivolumab

Nivolumab

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

  • Oscar Juan Vidal, MD, PhD · Hospital Universitario La Fe

  • Stefania Salvagni, MD · Azienda Ospedaliero Universitarua, Policlinico S. Orsola Malpighi

  • Rossana Berardi, MD · Ospedali Riuniti di Ancona

  • Armando Santoro, MD · IRCCS Instituto Clinic Humanitas

  • Benjamin Besse, MD, PhD · Gustave Roussy, Ditep

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-12
Primary Completion
2024-07-16
Completion
2024-07-16

Countries

  • France
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03850067 on ClinicalTrials.gov