Clinical trial NCT02392455: VARGADO - Vargatef in 2nd-line Therapy of Non-Small Cell Lung Cancer (NSCLC)
Official title: Vargatef in 2nd-line Therapy of Advanced or Metastatic Adenocarcinoma of the Lung
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2015-03-19
Enrollment: 817
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: NSCLC patients

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients alive one year after start of therapy with Vargatef and Docetaxel (1-year survival rate)
timeFrame: up to 24 months
Secondary outcomes:
measure: One year survival rate of patients with first line progression within 9 months after start of first line therapy
timeFrame: up to 24 months
measure: Progression-free survival of patients with first line progression within 9 months after start of first line therapy
timeFrame: up to 24 months
measure: Median overall survival
timeFrame: up to 24 months
measure: Progression-free survival
timeFrame: up to 24 months
measure: Tumour control rate (complete response, partial response, stable disease)
timeFrame: up to 24 months
measure: Incidence of side effects
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Grohe C, Blau W, Gleiber W, Haas S, Hammerschmidt S, Kruger S, Muller-Huesmann H, Schulze M, Wehler T, Atz J, Kaiser R. Real-World Efficacy of Nintedanib Plus Docetaxel After Progression on Immune Checkpoint Inhibitors: Results From the Ongoing, Non-interventional VARGADO Study. Clin Oncol (R Coll Radiol). 2022 Jul;34(7):459-468. doi: 10.1016/j.clon.2021.12.010. Epub 2022 Jan 7.
citation: Grohe C, Gleiber W, Haas S, Losem C, Mueller-Huesmann H, Schulze M, Franke C, Basara N, Atz J, Kaiser R. Nintedanib plus docetaxel after progression on immune checkpoint inhibitor therapy: insights from VARGADO, a prospective study in patients with lung adenocarcinoma. Future Oncol. 2019 Aug;15(23):2699-2706. doi: 10.2217/fon-2019-0262. Epub 2019 Jul 8.