Clinical Trials /

LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research

NCT02231164

Description:

The present trial will investigate the efficacy and safety of nintedanib in combination with docetaxel as compared to placebo in combination with docetaxel in patients with stage IIIB/IV or recurrent NSCLC of adenocarcinoma histology after failure of first-line platinum-based chemotherapy.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 3

Trial Eligibility

Document

LUME-Columbus: <span class="go-doc-concept go-doc-intervention">Nintedanib</span> Plus <span class="go-doc-concept go-doc-intervention">Docetaxel</span> in Advanced Non-small Cell <span class="go-doc-concept go-doc-disease">Lung Cancer</span> With Translational Research

Title

  • Brief Title: LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research
  • Official Title: Multicentre, Randomised, Double-blind, Phase III Trial to Investigate the Efficacy and Safety of Oral Nintedanib Plus Docetaxel Therapy Compared to Placebo Plus Docetaxel Therapy in Patients With Stage IIIB/IV or Recurrent, Adenocarcinoma Subtype Non-small Cell Lung Cancer After Failure of First Line Chemotherapy
  • Clinical Trial IDs

    NCT ID: NCT02231164

    ORG ID: 1199.128

    Trial Conditions

    Carcinoma, Non-Small-Cell Lung

    Trial Interventions

    Drug Synonyms Arms
    docetaxel Docetaxel and Nintedanib
    docetaxel Docetaxel and placebo
    placebo Docetaxel and placebo
    nintedanib Docetaxel and Nintedanib

    Trial Purpose

    The present trial will investigate the efficacy and safety of nintedanib in combination with
    docetaxel as compared to placebo in combination with docetaxel in patients with stage
    IIIB/IV or recurrent NSCLC of adenocarcinoma histology after failure of first-line
    platinum-based chemotherapy.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Docetaxel and placebo Placebo Comparator patients to receive backbone chemotherapy and placebo docetaxel, placebo
    Docetaxel and Nintedanib Experimental patients to receive backbone chemotherapy and nintedanib docetaxel, nintedanib

    Eligibility Criteria

    Inclusion criteria:

    - Male or female patients of at least 18 years of age

    - Histologically confirmed, adenocarcinoma of the lung, after failure of first line
    platinum-based chemotherapy.

    Exclusion criteria:

    - More than one prior line of chemotherapy (i.e., 2nd or 3rd line chemotherapy) for
    advanced and/or metastatic (stage III B or IV NSCLC) or recurrent disease.

    - Patients known to be positive for activating Epidermal Growth Factor Receptor (EGFR)
    mutation or anaplastic lymphoma kinase (ALK) translocation

    - Previous therapy with other vascular endothelial growth factor (VEGF) or VEGFR
    inhibitors (other than bevacizumab) or docetaxel for the treatment of NSCLC at any
    time

    - Prior monotherapy with an EGFR inhibitor except as maintenance therapy

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Progression free Survival

    Overall Survival

    Secondary Outcome Measures

    Objective tumour response by central independent review

    Disease control rate by central independent review

    Quality of life (QOL); time to deterioration of cough,

    Quality of life; dyspnea

    Quality of life; pain

    Quality of life; the global health status/QOL summary score

    Trial Keywords