drugset / Trial / NCT01757288

Phase I/II NabPaclitaxel, Paclitaxel&Carboplatin w RTX Followed by Consolidation in Patients w Favorable Prognosis Inoperable Stage IIIA/B NSCLC

NCT01757288 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

The investigators propose this phase I/II study to use weekly Nab-Paclitaxel (Abraxane) and carboplatin with concurrent radiation in local-regionally advanced lung cancer. There are no published human studies combining Nab-Paclitaxel (Abraxane) with radiation. The investigators will first confirm the tolerated dose (TD) of concurrent Nab-Paclitaxel (Abraxane) at 50mg/m2, and then will begin enrolling patients into the phase II component using either Nab-Paclitaxel (Abraxane) at the TD with carboplatin concurrent with daily radiation or paclitaxel with carboplatin concurrent with daily radiation.

Timeline

Start
2013-03-25
Primary completion
2019-06-03
Completion
2019-06-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Nab-paclitaxel Small molecule 40 mg/m2 Intravenous
Subject Nab-paclitaxel Small molecule 50 mg/m2 Intravenous
Comparator Paclitaxel Small molecule — —