Boeringer-Ingelheim 1199.128

Multcentre, randomised, double-blind, phase III trial to investigate the efficacy and safety of oral nintedanib plus docetaxel therapy compared to placebo plus docetaxel therapy in patients with stage IIIB/IV or recurrent, adenocarcinoma subtype non-small cell lung cancer after failure of first-line chemotherapy

NCT02231164

Lung cancer (c), NSCLC, Adenocarcinoma

Stage 4

Metastatic/Palliative

2nd

Nintedanib

VEGFR, FGFR, and PDGFR TKI

Ari VanderWalde, MD

Boeringer Ingelheim

Phase 3

Closed to Accrual

https://www.clinicaltrials.gov/ct2/show/NCT02231164

Metastatic lung adenoCA following failure of 1st line platinum-based chemo
Continued or switch maintenance is considered still "1st line"
ECOG PS 0-1
No EGFR mutations, No ALK translocations
No prior anti-VEGFRs except bevacizumab
No clinically significant pleural effusions
No active brain mets
No cavitary/necrotic tumors or evidence of invasion of major arteries.
No anti-thrombotic therapy (warfarin)
No more than 1 tsp/day of hemoptysis
No prior monotherapy with EGFR inhibitor
No XRT to lung or abdomen within last 3 months
No ALT/AST >1.5x ULN

Primary- PFS, OS. Secondary- ORR, DCR, QOL

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Adenocarcinoma

Docetaxel 75mg/m2 IV on Day 1. Nintedanib/placebo- 300mg PO bid after meals Day 2-21

Docetaxel+placebo

Yes