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

Conditions

Carcinoma, Non-Small-Cell Lung

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.

Virginie Westeel, Wolfgang Schuette, T. Urban, Dejan Radonjic, Ute von Wangenheim et al. (7 authors)

PLoS ONE2023-10-172 citations

10.1371/journal.pone.0292307

Impact of PD-L1 and <i>KRAS</i> status on the efficacy of nintedanib (NIN) + docetaxel (DOC) following treatment with first-line immune checkpoint inhibitor (ICI) + chemotherapy in patients with adenocarcinoma NSCLC: Analysis of cohort C of the non-interventional VARGADO trial.

Christian Grohé, Thomas Wehler, Sven Henschke, Stefan Hammerschmidt, Christoph Aulmann et al. (12 authors)

Journal of Clinical Oncology2023-06-011 citations

10.1200/jco.2023.41.16_suppl.e21149

Nintedanib plus docetaxel after progression on first-line immunochemotherapy in patients with lung adenocarcinoma: Cohort C of the non-interventional study, VARGADO.

Grohé C, Wehler T, Dechow T, Henschke S, Schuette W, Dittrich I, Hammerschmidt S, Müller-Huesmann H, Schumann C, Krüger S, Atz J, Kaiser R.

2022-10-0117 citations

10.21037/tlcr-21-1018

Effect of performance status (ECOG PS) on treatment outcome with second-line (2L) nintedanib (NIN) + docetaxel (DOC) for patients (pts) with lung adenocarcinoma after first-line (1L) immune checkpoint inhibitor (ICI) combination therapy.

Christian Grohé, Thomas Wehler, Sven Henschke, Ina Dittrich, Stefan Hammerschmidt et al. (12 authors)

Journal of Clinical Oncology2022-06-011 citations

10.1200/jco.2022.40.16_suppl.9092

Real-World Efficacy of Nintedanib Plus Docetaxel After Progression on Immune Checkpoint Inhibitors: Results From the Ongoing, Non-interventional VARGADO Study.

Grohé C, Blau W, Gleiber W, Haas S, Hammerschmidt S, Krüger S, Müller-Huesmann H, Schulze M, Wehler T, Atz J, Kaiser R.

2022-01-0717 citations

10.1016/j.clon.2021.12.010

Second-line nintedanib plus docetaxel for patients with lung adenocarcinoma after failure on first-line immune checkpoint inhibitor combination therapy: Initial efficacy and safety results from VARGADO Cohort C.

Christian Grohé, Thomas Wehler, Tobias Dechow, Sven Henschke, Wolfgang Schuette et al. (12 authors)

Journal of Clinical Oncology2021-05-204 citations

10.1200/jco.2021.39.15_suppl.9033

Nintedanib + docetaxel in lung adenocarcinoma patients (pts) following treatment with immune checkpoint inhibitors (ICIs): Updated efficacy and safety results of the ongoing non-interventional study (NIS) VARGADO (NCT02392455).

Christian Grohé, Wolfgang Blau, Wolfgang Gleiber, Siegfried Haas, Stefan Krüger et al. (9 authors)

Journal of Clinical Oncology2020-05-205 citations

10.1200/jco.2020.38.15_suppl.9604

Nintedanib Plus Docetaxel After Progression on Immune Checkpoint Inhibitor Therapy: Insights from VARGADO, A Prospective Study in Patients with Lung Adenocarcinoma

Christian Grohé, Wolfgang Gleiber, Siegfried Haas, Christoph Losem, H. Mueller-Huesmann et al. (10 authors)

Future Oncology2019-07-0825 citations

10.2217/fon-2019-0262

Nintedanib plus docetaxel in lung adenocarcinoma patients (pts) following treatment with immune checkpoint inhibitors (ICIs): Preliminary efficacy and safety results of the non-interventional study VARGADO.

Christian Grohé, Wolfgang Blau, Wolfgang Gleiber, Siegfried Haas, H. Mueller-Huesmann et al. (8 authors)

Journal of Clinical Oncology2019-05-204 citations

10.1200/jco.2019.37.15_suppl.9074

Efficacy and safety of nintedanib + docetaxel in lung adenocarcinoma patients (pts) following treatment with immune checkpoint inhibitors (ICIs): First results of the ongoing non-interventional study (NIS) VARGADO

C. Grohe, Wolfgang Gleiber, Siegfried Haas, H. Mueller-Huesmann, M. Schulze et al. (7 authors)

Annals of Oncology2019-04-011 citations

10.1093/annonc/mdz063.017

Efficacy and safety of nintedanib and docetaxel in lung adenocarcinoma patients (pts) following treatment with immune checkpoint inhibitors (ICIs): First interim results of the ongoing non-interventional study VARGADO (NCT02392455)

C. Grohe, Wolfgang Gleiber, Siegfried Haas, H. Mueller-Huesmann, M. Schulze et al. (7 authors)

Annals of Oncology2018-12-01

10.1093/annonc/mdy486.007

Nintedanib plus docetaxel in routine clinical practice: VARGADO, a German prospective non-interventional study (NIS) reflecting routine treatment conditions in an evolving NSCLC treatment landscape

Christian Grohé, I. Zander, Kerstin Lüdtke-Heckenkamp, Werner J. Blau, Stefan Krüger et al. (13 authors)

Annals of Oncology2018-10-012 citations

10.1093/annonc/mdy292.125

Interventions

DRUGtreatment

Docetaxel plus nintedanib until progression or intolerability

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Percentage of patients alive one year after start of therapy with Vargatef and Docetaxel (1-year survival rate)	up to 24 months

Secondary

Measure	Time frame
Progression-free survival of patients with first line progression within 9 months after start of first line therapy	up to 24 months
Median overall survival	up to 24 months
One year survival rate of patients with first line progression within 9 months after start of first line therapy	up to 24 months
Tumour control rate (complete response, partial response, stable disease)	up to 24 months
Incidence of side effects	up to 24 months
Progression-free survival	up to 24 months

Countries

Germany

Outcome results

None listed