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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

817 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-23

Study Completion Date

2025-07-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Nintedanib (Vargatef®) Plus Docetaxel in Second Line of Treatment in Patients With Lung Cancer

NCT02531737

Lung Neoplasms

COMPLETED PHASE2

Phase II Randomized Trial of Carboplatin+Pemetrexed+Bevacizumab+/- Atezolizumab in Stage IV NSCLC

NCT03786692

Non-Small Cell Carcinoma of Lung, TNM Stage 4

RECRUITING PHASE2

Nintedanib in Molecularly Selected Patients With Advanced Non-Small Cell Lung Cancer

NCT02299141

Carcinoma, Non-Small-Cell Lung Non-Small Cell Lung Cancer Nonsmall Cell Lung Cancer

COMPLETED PHASE2

Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma

NCT02668393

Carcinoma, Non-Small-Cell Lung

COMPLETED PHASE1

Docetaxel in Treating Patients With Non-Small Cell Lung Cancer

NCT00022022

Lung Cancer

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carcinoma, Non-Small-Cell Lung

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

treatment

Intervention Type DRUG

Docetaxel plus nintedanib until progression or intolerability

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

treatment

Docetaxel plus nintedanib until progression or intolerability

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No