NCT02799862

Nab-Paclitaxel in Combination With Carboplatin as First-line Therapy in Patients With NSCLC

A Non-interventional Study of Nab-paclitaxel (Abraxane®) in Combination With Carboplatin as First Line Therapy in Patients With Advanced Non-small Cell Lung Cancer (NEPTUN)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 408 (actual)
• Sponsor: iOMEDICO AG · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm non-interventional study (NIS) to evaluate the effectiveness, safety and quality of life (QoL) in patients with advanced NSCLC receiving the combination of nab-paclitaxel and carboplatin as first line palliative therapy in a real life setting.

Detailed description

The present NIS is designed to provide additional knowledge in terms of effectiveness, safety and quality of life in routine administration of the combination of nab-paclitaxel (Abraxane®) and carboplatin as first line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are not candidates for potentially curative surgery and / or radiation therapy. The combination of Abraxane® and carboplatin has been approved in Europe in March 2015 based on results from a pivotal randomized, open label phase III study with 1,052 patients.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Nab-Paclitaxel	Nab-Paclitaxel will be administered in accordance with the SmPC of Nab-Paclitaxel.
DRUG	Carboplatin	Carboplatin will be administered as combination partner of Nab-Paclitaxel in accordance with SmPC of Nab-Paclitaxel.

Timeline

• Start date: 2016-08-29
• Primary completion: 2019-12-07
• Completion: 2021-06-06
• First posted: 2016-06-15
• Last updated: 2021-10-06

Locations

1 site across 1 country: Germany