An observational study in Carcinoma, Non-Small-Cell Lung, sponsored by iOMEDICO AG. Completed at 1 site in Germany. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-10-06.
Sponsored by iOMEDICO AG · Observational
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.
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.
6,485 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.
This study's enrollment of 408 is above the median of 161 across 948 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →iOMEDICO AG is the lead sponsor of 52 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients with locally advanced / metastatic NSCLC who are not candidates for potentially curative surgery and / or radiation therapy
Exclusion Criteria:
Nab-Paclitaxel will be administered in accordance with the SmPC of Nab-Paclitaxel.
Also known as: Abraxane
Carboplatin will be administered as combination partner of Nab-Paclitaxel in accordance with SmPC of Nab-Paclitaxel.
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.
Time frame: After 6-months
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).
Time frame: 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).
Time frame: 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.
Time frame: through study completion, an average of 9 months
Patient-reported outcomes on Quality of Life
Questionnaires: EQ5D-5L and FACT-L
Time frame: 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
Time frame: Baseline
Plan to share: No
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
iOMEDICO AG