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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 : August 8, 2019
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
iOMEDICO AG

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.

Condition or disease Intervention/treatment
Carcinoma, Non-Small-Cell Lung Drug: Nab-Paclitaxel Drug: Carboplatin

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.

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Study Type : Observational
Actual Enrollment : 408 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.

  4. 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

  5. Rationale for physicians' treatment decision [ Time Frame: Baseline ]
    Rationale for physicians' treatment decision, assessed with a therapy-decision questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • According to SmPC

Information from the National Library of Medicine

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


Locations
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Germany
iOMEDICO
Freiburg, Baden-Württemberg, Germany, 79106
Sponsors and Collaborators
iOMEDICO AG
Celgene Corporation
Investigators
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Principal Investigator: Tobias Dechow, Prof. Dr. Oncology Ravensburg

Publications:
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Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT02799862     History of Changes
Other Study ID Numbers: IOM-110333
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by iOMEDICO AG:
metastatic
locally advanced
unresectable
NSCLC
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action