Ceritinib in Combination With Stereotactic Ablative Radiation Metastatic Lung Adenocarcinoma

ALK-positive Non-small Cell Lung Cancer Clinical Trial

Official title: Phase II Trial of Ceritinib in Combination With Stereotactic Ablative Radiation in ALK-rearranged Metastatic Lung Adenocarcinoma

Status Terminated

Clinical Trial Summary

The purpose of this study is to see if Ceritinib can target ALK in non-small cell lung cancer and slow down cancer growth and prevent it from spreading.

Clinical Trial Description

This is an, open-label, two-cohort protocol designed to evaluate the activity of targeted therapy and SABR in ALK positive lung adenocarcinoma.

Cohort A will evaluate the combination in ALK-inhibitor naïve patients. Cohort B will evaluate the combination in patients who have received treatment with one prior ALK inhibitor.

Ceritinib will be administered to the patient until disease progression by RECIST 1.1, unacceptable toxicity, withdrawal of consent, or discontinuation of the trial for any other reason including death.

The primary focus of this protocol is identifying response in ALK+ lung cancer patients. Patients with Ventana assay and Vysis FISH probe positive tumors will be treated. Evidence of ALK gene rearrangement will also be considered eligible for the trial.

Primary Objective:

Cohort A: Superiority of ceritinib + SABR median PFS compared to historical control of 10 months (expected to be 20 months)

Endpoint:

Cohort A Median PFS defined as time from initiation of ceritinib until disease progression by RECIST 1.1, unacceptable toxicity, withdrawal of consent, or discontinuation of the trial for any other reason including death.

Primary:

Cohort B: Superiority of ceritinib + SABR median PFS compared to historical control of 7 months.

Endpoint:

Cohort B: Median PFS defined as time from initiation of ceritinib until disease progression by RECIST 1.1, unacceptable toxicity, withdrawal of consent, or discontinuation of the trial for any other reason including death.

Secondary:

• Report Overall survival Overall survival

• Report Time to 2nd SABR Time from start of systemic therapy to first day of second course of SABR

• Report Time to 3rd SABR Time from start of therapy to first day of third course of SABR

• Report proportion of patients CR/PR/stable disease at 6 and12 months Number of patients with CR/PR/stable disease for 6 and 12 months after initiation

Safety:

-Demonstrate safety of ceritinib followed by SABR Describe toxicity and adverse events (CTCAE v.4) compared to historical controls. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• ALK-positive Non-small Cell Lung Cancer

• NCT number: NCT02513667
• Study type: Interventional
• Source: University of Texas Southwestern Medical Center
• Status: Terminated
• Phase: Phase 2
• Start date: November 2015
• Completion date: May 29, 2021