Nab-Paclitaxel in Combination With Carboplatin as First-line Therapy in Patients With NSCLC
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Registration Number
- NCT02799862
- Lead Sponsor
- iOMEDICO AG
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 408
- Histologically confirmed diagnosis of locally advanced / metastatic, unresectable NSCLC
- According to SmPC
- According to SmPC
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) rate After 6-months Effectiveness in terms of PFS will be assessed and evaluated according to local medical standards from screening until end of treatment observation (6 months). Additional survival and and if applicable clinical PFS will be followed up for 24 months post-treatment observation.
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR) After 6-months Effectiveness in terms of ORR will be assessed and evaluated according to local medical standards from screening until end of treatment observation (6 months).
Safety - Adverse events (AEs) through study completion, an average of 9 months Safety assessments will consist of monitoring of all AEs, including serious adverse events, and monitoring of laboratory values. AEs will be graded according to CTCAE V4.03. Supportive therapies will be documented.
Patient-reported outcomes on Quality of Life Baseline, after 6 weeks, after 3 months, every 3 months throughout study completion, an average of 9 months Questionnaires: EQ5D-5L and FACT-L
Median Overall Survival (OS) After 6-months Effectiveness in terms of OS will be assessed and evaluated according to local medical standards from screening until end of treatment observation (6 months).
Rationale for physicians' treatment decision Baseline Rationale for physicians' treatment decision, assessed with a therapy-decision questionnaire
Trial Locations
- Locations (1)
iOMEDICO
🇩🇪Freiburg, Baden-Württemberg, Germany