Phase II study of docetaxel monotherapy plus primary prophylaxis with pegfilgrastim for pre-treated locally advanced or metastatic non-small cell lung cancer.

Phase II study of docetaxel monotherapy plus primary prophylaxis with pegfilgrastim for pre-treated locally advanced or metastatic non-small cell lung cancer. - OPH-RM-LC-1501

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016383

Enrollment

Registered

2015-02-02

Start date

2015-02-02

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

Addition of primary prophylaxis with pegfilgrastim to docetaxel monotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed non-small cell lung cancer 2) Stage III / IV or recurrence after surgery, without any indications for radiotherapy or surgery 3) Evaluable disease (RECIST ver1.1) 4) Progressive disease or recurrence after platinum-containing chemotherapy Pre-treated with EGFR-TKI in patients with active EGFR mutation. Pre-treated with ALK inhibitor in ALK-positive patient Adjuvant platinum-containing chemotherapy was considered as one regimen. Interval; two week after thoracic radiotherapy 5) Age over 20 year-old 6) ECOG Performance status 0-2 7) Adequate organ function, evaluated within 14 days before enrollment 8) Expected 3 month survival 9) Written informed consent

Exclusion criteria

Exclusion criteria: (1) A history of docetaxel treatment (2)Current or previous history of pulmonary fibrosis, interstitial pneumonitis or drug-induced pneumonia, revealed by chest X-ray film (3)Concurrent thoracic radiotherapy (4) A history of severe hypersensitivity against docetaxel or pegfilgrastim (5)Another active advanced malignancy that requires any concurrent treatment with treatment for lung cancer (6)Pleural effusion, ascites or peri-cardiac effusion requiring dranage. (7)Problematic complications (8) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy (9) Decision of ineligibility by a physician

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Secondary

Measure	Time frame
Response rate, Overall survival, Frequency of febrile neutropenia, Frequency of Grade 4 neutropenia, Adverse effects	—

Countries

Japan

Contacts

Public ContactSeigo Minami

Osaka Police Hospital Dept. of Respiratory Medicine

seigominami@oph.gr.jp06-6771-6051

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026