Clinical trial · Observational
VARGADO - Vargatef in 2nd-line Therapy of Non-Small Cell Lung Cancer (NSCLC)
Vargatef in 2nd-line Therapy of Advanced or Metastatic Adenocarcinoma of the Lung
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| treatment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- A
- interventionNames
- Drug: treatment
Primary outcomes (1)
- 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 (6)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDGrohe 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. PMID 35012901
- DERIVEDGrohe 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. PMID 31282758