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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: Nab-Paclitaxel
* Drug: Carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed diagnosis of locally advanced / metastatic, unresectable NSCLC According to SmPC Exclusion Criteria: According to SmPC

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) rate | 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. | After 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Overall Survival (OS) | Effectiveness in terms of OS will be assessed and evaluated according to local medical standards from screening until end of treatment observation (6 months). | After 6-months | 
| Overall Response Rate (ORR) | Effectiveness in terms of ORR will be assessed and evaluated according to local medical standards from screening until end of treatment observation (6 months). | After 6-months | 
| Safety - Adverse events (AEs) | 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. | through study completion, an average of 9 months | 
| Patient-reported outcomes on Quality of Life | Questionnaires: EQ5D-5L and FACT-L | Baseline, after 6 weeks, after 3 months, every 3 months throughout study completion, an average of 9 months | 
| Rationale for physicians' treatment decision | Rationale for physicians' treatment decision, assessed with a therapy-decision questionnaire | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic, locally advanced, unresectable, NSCLC