NCT02513667

Ceritinib in Combination With Stereotactic Ablative Radiation Metastatic Lung Adenocarcinoma

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• ALK-positive Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Ceritinib	Patients will receive ceritinib at a dose of 750 mg (150 mg capsules times 5 capsules once a day) for 10 weeks. Patient will stop taking Ceritinib 72 hours before SABR radiation. The patient may start taking Ceritinib again 72 hours after radiation is complete. Patient will continue to take certinib for up to 8 months.
RADIATION	Stereotactic ablative body radiation	Patients will receive study drug for 10 weeks. They could get 1, 3 ,or 5 treatments on consecutive days with 18 hours between each treatment or every other day (doctor's determination).

Timeline

• Start date: 2015-11-01
• Primary completion: 2020-05-29
• Completion: 2021-05-29
• First posted: 2015-07-31
• Last updated: 2023-02-03
• Results posted: 2021-12-17

Locations

1 site across 1 country: United States