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Completed

NCT Number: NCT02799862

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

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.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

iOMEDICO

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • According to SmPC

Treatment and study plan

Nab-paclitaxel

Drug

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

Other names: Abraxane

carboplatin

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

iOMEDICO AG

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study 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)

Acronym: NEPTUN

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
Jun 15, 2016
Registry last updated
Oct 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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