Clinical trial · Observational
Nab-Paclitaxel in Combination With Carboplatin as First-line Therapy in Patients With NSCLC
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)
NCT02799862CI-TRIAL-00054290NEPTUNcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Nab-Paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression Free Survival (PFS) rate
- timeFrame
- After 6-months
- description
- 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 outcomes (5)
- measure
- Median Overall Survival (OS)
- timeFrame
- After 6-months
- description
- Effectiveness in terms of OS will be assessed and evaluated according to local medical standards from screening until end of treatment observation (6 months).
- measure
- Overall Response Rate (ORR)
- timeFrame
- After 6-months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of locally advanced / metastatic, unresectable NSCLC * According to SmPC Exclusion Criteria: * According to SmPC
References
Publications (6)
- BACKGROUNDvan 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. PMID 7642691
- BACKGROUNDSocinski 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. PMID 22547591
- BACKGROUNDTorre 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. PMID 25651787
- BACKGROUNDReck 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. PMID 25115305
- BACKGROUNDGelderblom 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. PMID 11527683
- DERIVEDDechow T, Riera-Knorrenschild J, Hackanson B, Janssen J, Schulz H, Oppermann U, Chiabudini M, von Weikersthal LF, Budweiser S, Nacke A, Taeuscher D, Welslau M, Potthoff K. First-line nab-paclitaxel plus carboplatin for patients with advanced non-small cell lung cancer: Final results of the NEPTUN study. Int J Cancer. 2023 Jul 1;153(1):141-152. doi: 10.1002/ijc.34467. Epub 2023 Mar 8. PMID 36757197