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

NCT02799862 | Completed

• 1 other identifier: IOM-110333
• Study Type: observational
• Target: 408
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

metastatic; locally advanced; unresectable; NSCLC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Median Overall Survival (OS)

  After 6-months

• Overall Response Rate (ORR)

  After 6-months

• Safety - Adverse events (AEs)

  through study completion, an average of 9 months

• Patient-reported outcomes on Quality of Life

  Baseline, after 6 weeks, after 3 months, every 3 months throughout study completion, an average of 9 months

• Rationale for physicians' treatment decision

  Baseline

Interventions

Nab-Paclitaxel DRUG

Nab-Paclitaxel will be administered in accordance with the SmPC of Nab-Paclitaxel.

Also known as: Abraxane

Carboplatin DRUG

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• According to SmPC

Sponsors & Collaborators

• iOMEDICO AG: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

iOMEDICO

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Related Publications (6)

• 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.

  PMID: 7642691 BACKGROUND

• 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.

  PMID: 22547591 BACKGROUND

• 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.

  PMID: 25651787 BACKGROUND

• 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.

  PMID: 25115305 BACKGROUND

• 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.

  PMID: 11527683 BACKGROUND

• Dechow 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 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Coordination Complexes

Study Officials

• Tobias Dechow, Prof. Dr.

  Oncology Ravensburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: June 15, 2016
• Study Start: August 29, 2016
• Primary Completion: December 7, 2019
• Study Completion: June 6, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)