A multicenter, prospective observational study of pegfilgrastim for the management of febrile neutropenia during ramucirumab plus docetaxel for patients with advanced non-small cell lung cancer (CJLSG 1602)

A multicenter, prospective observational study of pegfilgrastim for the management of febrile neutropenia during ramucirumab plus docetaxel for patients with advanced non-small cell lung cancer (CJLSG 1602) - Observational study of pegfilgrastim for the management of febrile neutropenia during ramucirumab plus docetaxel

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000026927

Enrollment

Registered

2017-04-10

Start date

2017-03-01

Completion date

Unknown

Last updated

2026-06-29

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

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histology/cytology-proven non-small cell lung cancer 2) Previously treated non-small cell lung cancer with stage III, IV or recurrent disease 3) Patient previously treated with at least two regimens of chemotherapy *It does not count as one regimen; treatment with PD-1/PD-L1 checkpoint inhibitors, anti-CTLA-4, EGFR-TKIs in patients with EGFR-mutated patients, ALK-TKIs in patients with ALK-positive patients, ROS-1-TKIs in patients with ROS-1-positive patients. *Recurrence within 6 months or less from the day adjuvant chemotherapy finished is considered a previous treatment. 4) Age of 70 years or over 5) Patients who are considered to survive for more than 3 months 6) Written informed consent 7) ECOG performance status of 0-2 8) Adequate organ function.

Exclusion criteria

Exclusion criteria: 1) Active infection 2) Patients had brain tumors and/or brain metastases (symptomatic or requiring treatment) 3) Evidence of tumor invading a perihilar blood vessel 4) Having a cavitating lung tumor 5) History of pulmonary hemorrhage or hemoptysis over 2.5 ml within 2 months 6) Evidence of tumor invading segmental bronchus 7) Severe gastrointestinal complications 8) Having a history or evidence of thrombosis 9) Severe hypertension 10) Having a history or evidence of ILD complication 11) Having an allergy of ramucirumab, docetaxel and pegfilgrastim 12) Having a severe mental disorder 13) Pregnant woman 14) Patients whose participation in the trial is judged to be inappropriate by the doctor

Design outcomes

Primary

Measure	Time frame
Incidence of febrile neutropenia during all cycles of ramucirumab plus docetaxel therapy	—

Secondary

Measure	Time frame
1) Incidence of febrile neutropenia during the first cycle of chemotherapy 2) Incidence of G4 neutropenia during the first cycle of chemotherapy 3) Incidence of G4 neutropenia during the all cycles of chemotherapy 4) Response rate 5) Relative dose intensity 6) Adverse events	—

Countries

Japan

Contacts

Public ContactTeppei Yamaguchi

Aichi Cancer Center Hospital Department of Thoracic Oncology

yteppei@aichi-cc.jp052-762-6111

Outcome results