VARGADO - Vargatef in 2nd-line Therapy of Non-Small Cell Lung Cancer (NSCLC)

  • STATUS
    Recruiting
  • End date
    Jan 31, 2025
  • participants needed
    700
  • sponsor
    Boehringer Ingelheim
Updated on 30 July 2023
docetaxel
cancer chemotherapy
recurrent non-small cell lung cancer
lung carcinoma

Summary

This observational study will investigate the efficacy and tolerability of Vargatef (Nintedanib) plus docetaxel in daily routine second-line treatment in patients with locally advanced, metastatic or locally recurrent NSCLC. Treatment with Vargatef in eligible NSCLC patients, for whom the treating physician has decided to initiate treatment with Vargatef in second line according to the local label, will be observed for up to 24 months. Survial follow-up will be done until the end of the study.

Details
Condition Carcinoma, Non-Small-Cell Lung
Treatment Treatment
Clinical Study IdentifierNCT02392455
SponsorBoehringer Ingelheim
Last Modified on30 July 2023

Eligibility

Yes No Not Sure

Inclusion Criteria

age 18 or older
men and women locally advanced, metastastic and/or recurrent NSCLC with adenocarcinoma histology for which vargatef treatment is indicated according to Summary of Product Characteristics (SmPC)
after first line chemotherapy. This includes also combinations of immune- and chemotherapy
standard 21-day-cycles docetaxel treatment according to SmPC possible
written informed consent

Exclusion Criteria

contraindications according to the SmPC of Vargatef or Docetaxel
more than one chemotherapy for treatment of NSCLC in palliative setting
current partcipation in a clinical trial
pregnancy
breastfeeding
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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