CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 49 enrolled
Drug / intervention
RAD001 +2 moredrug
Likely dose
RAD001 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01317615
NCT01317615Phase 4Completed
CompareCT.gov

A Multi-centric, Open-label, Phase II Study Investigating the Combination of Afinitor With Paclitaxel and Carboplatin in First Line Treatment of Patients With Advanced (Stage IV) Large Cell Lung Cancer With Neuroendocrine Differentiation (LC-NEC)

Novartis Pharmaceuticals·interventional·Posted Mar 17, 2011·Updated Mar 30, 2016

In Brief

A Phase 4 clinical trial evaluating RAD001, Paclitaxel, and 1 other intervention for Carcinoma, Large Cell and Neuroendocrine Tumors. Completed, enrolled 49 participants across 9 sites.

Detailed Summary

This is a multi-centric, open-label study evaluating the efficacy and safety of RAD001 in patients with advanced (stage IV) Lung Cancer (Large Cell) with neuroendocrine differentiation treated with a combination of RAD001 with paclitaxel and carboplatin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Large Cell, Neuroendocrine Tumors
CountriesGermany
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 17, 2011
Enrollment StartApr 1, 2011
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 15.3 years ago

Interventions

RAD001drug

Participants started RAD001 treatment with a dose of 5 mg/day once daily. A dose decrease to 5 mg every other day was allowed if tolerability issues arose.

Paclitaxeldrug

Paclitaxel was started at doses of 175 mg/m². Dose reductions of Paclitaxel to 135 mg/m2 was permitted if tolerability issues arose.

Carboplatindrug

Carboplatin was started at doses of Area under the Curve 5 (AUC 5). Dose reductions of carboplatin to AUC 4 was permitted if tolerability issues arose.