Safety and Efficacy Study of Nab®-Paclitaxel With CC-486 or Nab®-Paclitaxel With Durvalumab, and Nab®-Paclitaxel Monotherapy as Second/Third-line Treatment for Advanced Non-small Cell Lung Cancer

NCT02250326 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2024-09-19

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Summary

This is a Phase 2, open-label, multicenter study to assess the efficacy and safety of second/third-line treatment with nab-paclitaxel in combination with the epigenetic modifying therapy of CC-486 or immunotherapy of durvalumab, and nab-paclitaxel monotherapy in subjects with advanced non-small cell lung cancer (NSCLC).

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

nab-paclitaxel IV

nab-Paclitaxel intravenous (IV) infusion

DRUG

CC-486

Oral CC-486

DRUG

Duravalumab

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-07
Primary Completion
2017-07-17
Completion
2023-08-17

Countries

  • United States
  • Canada
  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

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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 NCT02250326 on ClinicalTrials.gov