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Nintedanib Plus Docetaxel vs Placebo Plus Docetaxel in Non-Small Cell Lung Cancer After First-Line Chemotherapy Failure
Multicentre, randomised, double-blind, Phase III trial to investigate the efficacy and safety of oral nintedanib* plus standard docetaxel therapy compared with placebo plus standard docetaxel therapy in patients with Stage IIIB/IV recurrent non-small cell lung cancer (NSCLC) after failure of first-line chemotherapy.
Trial CT.gov-Identifier: NCT00805194
Histologically or cytologically confirmed Stage IIIB/IV recurrent NSCLC (all histologies)
Relapse or failure of one first-line chemotherapy
Eastern Cooperative Oncology Group performance status of 0–1
Histologies were balanced between treatment arms (adenocarcinoma n=658 [50.1%]; squamous cell carcinoma n=555 [42.2%]; other n=101 [7.7%])
Primary outcome measure:
Key secondary outcome measure:
Additional secondary outcome measures:
PFS, intent-to-treat population (all histologies):
Median PFS was 3.4 months for nintedanib plus docetaxel and 2.7 months for placebo plus docetaxel (hazard ratio [HR]=0.79; 95% confidence interval [CI]: 0.68–0.92; p=0.0019) regardless of histology.
Whilst there was no significant OS difference for the overall patient population, a prespecified analysis of OS identified a significant OS benefit beyond 1 year with nintedanib plus docetaxel in patients with adenocarcinoma compared with placebo plus docetaxel.
For nintedanib plus docetaxel, the most frequent Grade ≥3 adverse events (AEs) were:
Overall, there was a slightly greater incidence of AEs at Grade ≥3 for nintedanib plus docetaxel compared with placebo plus docetaxel (71.3% vs 64.3%), but withdrawals due to AEs were similar in both arms (22.7% vs 21.7%). There was a low incidence of class effects typically associated with antiangiogenic agents, such as hypertension, bleeding, perforation and thromboembolism, and rates were similar for both groups.
Nintedanib plus docetaxel significantly improved PFS for patients with advanced NSCLC of all histologies, and provided a significant OS benefit for patients with adenocarcinoma beyond 1 year, following progression after initial chemotherapy.
Reck M, et al. Lancet Oncol 2014;15(2):143–155.
Reck M, et al. Lung Cancer 2015;90(2):267–273.
Gottfried M, et al. Target Oncol 2017 [Epub ahead of print]. doi:10.1007/s11523-017-0517-2. Accessed July 2017.
Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/NCT00805194 (Accessed: July 2017).
*Nintedanib is approved in the EU under the brand name VARGATEF® for use in combination with docetaxel in adult patients with locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma tumour histology after first-line chemotherapy. For the full list of country-specific information please click here. Nintedanib is not approved in other oncology indications.
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