ab-PTX vs DTX Phase III

Phase 3

• Conditions: on-small cell lung cancer; Lung cancer; D002289

• Registration Number: JPRN-jRCTs071180037
• Lead Sponsor: Okamoto Isamu

Brief Summary

The noninferiority of nab-paclitaxel relative to docetaxel was confirmed with regard to OS, and superiority was apparent with regard to PFS and ORR. Nab-paclitaxel for patients with advanced NSCLC previously treated with cytotoxic chemotherapy thus provides a clinically significant benefit in terms of its effectiveness and tolerability. Such treatment should therefore be considered a standard option for patients in this setting.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-11
• Study Completion: 2020-06-30
• Results First Posted: 2021-04-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 503

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified