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

Carcinoma, Non-Small-Cell Lung Clinical Trial

— NEPTUN  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02799862
• Other study ID #: IOM-110333
• Status: Completed
• Start date: August 29, 2016
• Est. completion date: June 6, 2021

Study information

• Verified date: October 2021
• Source: iOMEDICO AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: June 6, 2021
• Est. primary completion date: December 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed diagnosis of locally advanced / metastatic, unresectable NSCLC

• According to SmPC

Exclusion Criteria:

• According to SmPC

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Nab-Paclitaxel
Nab-Paclitaxel will be administered in accordance with the SmPC of Nab-Paclitaxel.
• Carboplatin
Carboplatin will be administered as combination partner of Nab-Paclitaxel in accordance with SmPC of Nab-Paclitaxel.

Locations

Country	Name	City	State
Germany	iOMEDICO	Freiburg	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
iOMEDICO AG	Bristol-Myers Squibb

Country where clinical trial is conducted

Germany, 

References & Publications (5)

Gelderblom H, Verweij J, Nooter K, Sparreboom A. Cremophor EL: the drawbacks and advantages of vehicle selection for drug formulation. Eur J Cancer. 2001 Sep;37(13):1590-8. Review. — View Citation

Reck M, Popat S, Reinmuth N, De Ruysscher D, Kerr KM, Peters S; ESMO Guidelines Working Group. Metastatic non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2014 Sep;25 Suppl 3:iii27-39. doi: 10.1093/annonc/mdu199. Epub 2014 Aug 11. — View Citation

Socinski MA, Bondarenko I, Karaseva NA, Makhson AM, Vynnychenko I, Okamoto I, Hon JK, Hirsh V, Bhar P, Zhang H, Iglesias JL, Renschler MF. Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial. J Clin Oncol. 2012 Jun 10;30(17):2055-62. doi: 10.1200/JCO.2011.39.5848. Epub 2012 Apr 30. — View Citation

Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4. — View Citation

van Warmerdam LJ, Rodenhuis S, ten Bokkel Huinink WW, Maes RA, Beijnen JH. The use of the Calvert formula to determine the optimal carboplatin dosage. J Cancer Res Clin Oncol. 1995;121(8):478-86. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Rationale for physicians' treatment decision	Rationale for physicians' treatment decision, assessed with a therapy-decision questionnaire	Baseline