Related Experiment Video
Updated: Jun 21, 2025
Utilizing 18F-FDG PET/CT Imaging and Quantitative Histology to Measure Dynamic Changes in the Glucose Metabolism in Mouse Models of Lung Cancer
Published on: July 21, 2018
A pilot study of nintedanib in molecularly selected patients with advanced non-small cell lung cancer
Christine Auberle1, Feng Gao1, Mark Sloan1
1Division of Oncology, Washington University School of Medicine in St. Louis, St. Louis, MO, USA.
Background:
Nintedanib is a small molecule tyrosine kinase inhibitor (TKI) targeting vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor (PDGFR), and fibroblast growth factor receptor (FGFR). The purpose of the study was to evaluate the response rate for patients with advanced non-small cell lung cancer (NSCLC) with mutations in TP53, VEGFR1-3, PDGFR-A, PDGFR-B, and FGFR1-3 treated with nintedanib as part of an open-label, single-arm pilot study.
Methods:
Patients with advanced NSCLC previously treated with platinum-doublet chemotherapy with the above mutations were enrolled. Exclusion criteria included necrotic tumors with invasion of blood vessels, history of recent thromboembolic events, increased risk of bleeding or thrombosis, myocardial infarction, and weight loss >10% within past 6 months. Nintedanib was administered at a dose of 200 mg orally twice daily until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Secondary endpoints included progression-free survival (PFS) and correlating outcomes with specific mutations. This study was registered with ClinicalTrials.gov, number NCT02299141.
Results:
Between 2015 and 2019, 20 patients were enrolled with a median age was 66 years, 15 (75%) were females, 15 (75%) had adenocarcinoma, and 17 patients had a TP53 mutation (85%). Seventeen (85%) had received prior immunotherapy and 11 (55%) had received at least three prior lines of systemic therapy. The ORR was 15% with three partial responses (PR), while 12 patients had stable disease (SD), with disease control rate (DCR) consisting of a PR and SD greater than or equal to 16 weeks of 65% (n=13). Median PFS was 4.3 months [95% confidence interval (CI): 1.8-7.9] and median overall survival (OS) was 11.3 months (95% CI: 3.5-44.2). Three patients experienced prolonged clinical benefit from nintedanib, remaining on treatment for over 1 year and all three had a TP53 mutation and received prior immunotherapy. The most common adverse events of any grade included nausea (80%), fatigue (70%), diarrhea (60%), and anorexia (60%).
Conclusions:
In this pilot study in heavily pretreated and molecularly selected patients with metastatic NSCLC, nintedanib showed modest activity.
Insights
Nintedanib demonstrated modest activity in heavily pretreated advanced non-small cell lung cancer (NSCLC) patients with specific mutations. The drug showed a 15% objective response rate and a 65% disease control rate in this pilot study.
Area of Science:
- Oncology
- Pharmacology
- Genetics
Background:
- Nintedanib is a tyrosine kinase inhibitor (TKI) targeting VEGFR, PDGFR, and FGFR.
- This study focused on advanced non-small cell lung cancer (NSCLC) patients with mutations in TP53, VEGFR, PDGFR, and FGFR.
Purpose of the Study:
- To evaluate the response rate of nintedanib in advanced NSCLC patients with specific genetic mutations.
- To assess the efficacy and safety of nintedanib in a molecularly selected patient cohort.
Main Methods:
- An open-label, single-arm pilot study enrolled 20 heavily pretreated advanced NSCLC patients.
- Nintedanib 200 mg orally twice daily was administered until disease progression or toxicity.
- Primary endpoint was objective response rate (ORR); secondary endpoints included progression-free survival (PFS).
Main Results:
- The objective response rate (ORR) was 15% (3 partial responses), with a disease control rate (DCR) of 65% (including stable disease >= 16 weeks).
- Median progression-free survival (PFS) was 4.3 months, and median overall survival (OS) was 11.3 months.
- Three patients with TP53 mutations and prior immunotherapy experienced prolonged benefit (>1 year). Common adverse events included nausea, fatigue, and diarrhea.
Conclusions:
- Nintedanib showed modest activity in heavily pretreated, molecularly selected advanced NSCLC patients.
- The drug's efficacy warrants further investigation in similar patient populations.
- Safety profile was consistent with known nintedanib side effects.
More Related Videos
07:59Author Spotlight: Advancements in Molecular Biomarker Testing for Non-Squamous Non-Small Cell Lung Cancer
Published on: September 8, 2023
04:04Endobronchial Ultrasound-guided Intratumoral Injection of Cisplatin for the Treatment of Isolated Mediastinal Recurrence of Lung Cancer
Published on: February 12, 2017
