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

iOMEDICO AG408 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

408

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Nab-PaclitaxelDRUG

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

CarboplatinDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically confirmed diagnosis of locally advanced / metastatic, unresectable NSCLC * According to SmPC Exclusion Criteria: * According to SmPC

Locations (1)

iOMEDICO

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Outcomes

Primary Outcomes

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.

Time frame: After 6-months

Secondary Outcomes

Median Overall Survival (OS)

Effectiveness in terms of OS will be assessed and evaluated according to local medical standards from screening until end of treatment observation (6 months).

Time frame: After 6-months

Overall Response Rate (ORR)

Effectiveness in terms of ORR will be assessed and evaluated according to local medical standards from screening until end of treatment observation (6 months).

Time frame: After 6-months

Safety - Adverse events (AEs)

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.

Time frame: through study completion, an average of 9 months

Patient-reported outcomes on Quality of Life

Questionnaires: EQ5D-5L and FACT-L

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

Rationale for physicians' treatment decision

Rationale for physicians' treatment decision, assessed with a therapy-decision questionnaire

Time frame: Baseline

Data from ClinicalTrials.gov

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