Neutropenic Sepsis in Patients With Non-Small Cell Lung Cancer Treated With Single-Agent Docetaxel and Associated Resource Use in the UK

A Retrospective Chart Review to Describe the Rate of Neutropenic Sepsis in Patients With Non-Small Cell Lung Cancer Treated With Single-Agent Docetaxel and Associated Resource Use in the UK

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02658747

Enrollment

120

Registered

2016-01-20

Start date

2016-05-25

Completion date

2016-07-25

Last updated

2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Brief summary

This is a multi-center retrospective observational research study collecting data for participants initiated on docetaxel for the treatment of relapsed non-small cell lung cancer (NSCLC) up to 6 years before start of data collection and who have completed/stopped docetaxel treatment at least 30 days prior to data collection. The primary goal of this study is to describe the percentage of participants with at least one neutropenic sepsis (NS) episode following initiation of treatment with single-agent docetaxel. Data will be collected until end of docetaxel treatment plus an additional 30 days to allow for presentation with toxicity.

Interventions

OTHERNo intervention

No intervention administered in this study

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosed with locally advanced or metastatic (stage Ill or IV) non-small cell lung cancer (NSCLC) * Relapsed disease following, or unable to tolerate, at least one line of prior chemotherapy * Initiated on single-agent docetaxel up to a maximum of 6 years prior to date of collection * Aged 18 years at date of first docetaxel dose * Completed or stopped treatment with docetaxel at least 30 days prior to date of data collection

Exclusion criteria

* Receiving docetaxel in an interventional clinical trial * For whom no details of absolute neutrophil count are recorded

Design outcomes

Primary

Measure	Time frame
Percentage of Participants Receiving Single-Agent Docetaxel Chemotherapy for Treatment of Relapsed Non-Small Cell Lung Cancer (NSCLC) with an Episode of Neutropenic Sepsis (NS) with an Absolute Neutrophil Count of Less Than 1.0 x 10^9/L	Up to 6 years

Secondary

Measure	Time frame
Percentage of Participants Receiving Single-Agent Docetaxel Chemotherapy for Treatment of Relapsed Non-Small Cell Lung Cancer (NSCLC) with an Episode of Neutropenic Sepsis (NS) with an Absolute Neutrophil Count of Less Than 0.5 x 10^9/L	Up to 6 years
Percentage of Participants with Docetaxel-Related Hematological Toxicities, Including Anemia, Thrombocytopenia, Neutropenia, Neutropenic Infection and Pancytopenia	Up to 6 years
Number of Episodes of Neutropenic Sepsis (NS) with an Absolute Neutrophil Count of Less Than 1.0 x 10^9/L	Up to 6 years
Frequency with which Participants Attend Hospital for Management of Specified Hematological Docetaxel-Related Toxicities, Including Anemia, Thrombocytopenia, Neutropenia, Neutropenic Infection and Pancytopenia	Up to 6 years
Number of Episodes of NS Associated with Death Attributable to NS	Up to 6 years
Percentage of Deaths Associated with the Occurrence of an NS Event	Up to 6 years
Number of Episodes of NS with an Absolute Neutrophil Count of Less Than 0.5 x 10^9/L	Up to 6 years

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026