To evaluate the efficacy and safety of nintedanib plus docetaxel in patients with
advanced adenocarcinoma non-small cell lung cancer (NSCLC) who progressed after chemotherapy
and immune checkpoint inhibitor (ICI) therapy.

Materials and methods

VARGADO (NCT02392455) is an ongoing, prospective, non-interventional, real-world study
of nintedanib plus docetaxel after first-line chemotherapy in the routine clinical
treatment of patients with locally advanced, metastatic or locally recurrent adenocarcinoma
NSCLC. Data were collected during routine visits. We report the results from cohort
B (n = 80), who received third-line nintedanib plus docetaxel after first-line chemotherapy
and second-line ICI therapy.


The median duration of follow-up was 12.4 months. Median progression-free survival
from initiation of third-line nintedanib plus docetaxel was 6.4 months (95% confidence
interval 4.8, 7.3); median overall survival was 12.1 months (95% confidence interval
9.4, 13.5). The 1-year overall survival rate after initiation of third-line nintedanib
plus docetaxel treatment (primary end point) was 52% (95% confidence interval 38.0%,
64.4%). Among 64 patients with a documented response, the objective response rate
was 50% (n = 32; one complete response and 31 partial responses) and the disease control rate
was 86% (n = 55). There were no new safety signals or unexpected toxicities. Among all treated
patients, 74% (n = 59) experienced drug-related adverse events, most commonly (nintedanib-related/docetaxel-related)
diarrhoea (34%/24%), a decreased white blood cell count (11%/19%) and nausea (13%/16%).


Nintedanib plus docetaxel demonstrated a high response rate and disease stabilisation
in the third-line setting after failure of prior chemotherapy and ICI treatment, with
a manageable safety profile. These results suggest that nintedanib plus docetaxel
represents an efficient treatment option after failure of prior ICIs. The ongoing
VARGADO study provides valuable real-world data to inform clinical decision-making
regarding treatment sequencing after chemotherapy and ICI failure in patients with
adenocarcinoma NSCLC.

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