Clinical trial NCT02799862: Nab-Paclitaxel in Combination With Carboplatin as First-line Therapy in Patients With NSCLC
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: metastatic
locally advanced
unresectable
NSCLC
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2016-06-15
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with locally advanced / metastatic NSCLC who are not candidates for potentially curative surgery and / or radiation therapy

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.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of locally advanced / metastatic, unresectable NSCLC
* According to SmPC

Exclusion Criteria:

* According to SmPC

Primary outcomes:
measure: Progression Free Survival (PFS) rate
timeFrame: After 6-months
Secondary outcomes:
measure: Median Overall Survival (OS)
timeFrame: After 6-months
measure: Overall Response Rate (ORR)
timeFrame: After 6-months
measure: Safety - Adverse events (AEs)
timeFrame: through study completion, an average of 9 months
measure: Patient-reported outcomes on Quality of Life
timeFrame: Baseline, after 6 weeks, after 3 months, every 3 months throughout study completion, an average of 9 months
measure: Rationale for physicians' treatment decision
timeFrame: Baseline
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: iOMEDICO
state: Baden-Württemberg
Study officials:
affiliation: Oncology Ravensburg
name: Tobias Dechow, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1007/BF01218365.
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.
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.
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. No abstract available.
citation: 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. doi: 10.1016/s0959-8049(01)00171-x.