Nab-Paclitaxel in Combination With Carboplatin as First-line Therapy in Patients With NSCLC (NEPTUN)
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|ClinicalTrials.gov Identifier: NCT02799862|
Recruitment Status : Active, not recruiting
First Posted : June 15, 2016
Last Update Posted : May 19, 2020
|Condition or disease||Intervention/treatment|
|Carcinoma, Non-Small-Cell Lung||Drug: Nab-Paclitaxel Drug: Carboplatin|
|Study Type :||Observational|
|Actual Enrollment :||408 participants|
|Official Title:||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)|
|Actual Study Start Date :||August 29, 2016|
|Actual Primary Completion Date :||December 7, 2019|
|Estimated Study Completion Date :||July 2021|
- Drug: Nab-Paclitaxel
Nab-Paclitaxel will be administered in accordance with the SmPC of Nab-Paclitaxel.Other Name: Abraxane
- Drug: Carboplatin
Carboplatin will be administered as combination partner of Nab-Paclitaxel in accordance with SmPC of Nab-Paclitaxel.
- Progression Free Survival (PFS) rate [ Time Frame: 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.
- Median Overall Survival (OS) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline ]Rationale for physicians' treatment decision, assessed with a therapy-decision questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02799862
|Freiburg, Baden-Württemberg, Germany, 79106|
|Principal Investigator:||Tobias Dechow, Prof. Dr.||Oncology Ravensburg|