nab-PTX vs DTX Phase III

JRCT ID: jRCTs071180037

Registered date:11/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 26/05/2015
• Target sample size: 500
• Study type: Interventional
• Intervention(s): Chemotherapy

Outcome(s)

• Primary Outcome: Overall survival
• Secondary Outcome: Progression-free survival, response rate, toxicity, QOL

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Histologically or cytologically confirmed diagnosis of NSCLC
2) Previously treated non-small cell lung cancer with stage IIIB, IV or recurrent disease
3) Patient previously treated with at least two regimens of chemotherapy
*Recurrence within a year or less from the day adjuvant chemotherapy finished is considered a previous treatment.
4) Age of 20 years or older
5) Performance Status (ECOG) 0-1
6) Tumor has the evaluable lesion

Exclude criteria

1) Treatment history of taxanes
2) Synchronous or metachronous active double malignancies
3) Infectious disease requiring systemic treatment
4) Fever of 38 degrees centigrade or higher
5) Psychotic disorder

Related Information

• Primary Sponsor: Okamoto Isamu
• Secondary Sponsor: Yoneshima Yasuto
• Source(s) of Monetary Support: TAIHO PHARMACEUTICAL CO., LTD.