Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
metastatic, locally advanced, unresectable, NSCLC
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.
Interventions
DRUGNab-Paclitaxel
Nab-Paclitaxel will be administered in accordance with the SmPC of Nab-Paclitaxel.
DRUGCarboplatin
Carboplatin will be administered as combination partner of Nab-Paclitaxel in accordance with SmPC of Nab-Paclitaxel.
Sponsors
Bristol-Myers Squibb
iOMEDICO AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed diagnosis of locally advanced / metastatic, unresectable NSCLC * According to SmPC
Exclusion criteria
* According to SmPC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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 |
| Rationale for physicians' treatment decision | Baseline | Rationale for physicians' treatment decision, assessed with a therapy-decision questionnaire |
Countries
Germany
Outcome results
None listed