A phase II, multicenter, single-arm study of oral LDK378 in adult patients with ALK-activated non-small cell lung cancer previously treated with chemotherapy and crizotinib

Phase 2

Completed

• Conditions: advanced non-small cell lung cancer; advanced NSCLC; 10038666

• Registration Number: NL-OMON41391
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 7

Inclusion Criteria

* Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC that carries an ALK rearrangement, as per the FDA-approved FISH assay (Abbott Molecular Inc.).
* Patients must have NSCLC that has progressed during therapy with crizotinib or within 30 days of the last dose
* Patients must have received 1-3 lines of cytotoxic chemotherapy (of which 1 must have been a platinum doublet) to treat their locally advanced or metastatic NSCLC
* Patients must have archival tissue sample available, collected either at the time of diagnosis of NSCLC or any time since.
*Patients must have recovered from all toxicities related to prior anticancer therapies to grade * 2, except for patients with grade 2 nausea/vomiting and/or grade 2 diarrhea despite optimal supportive therapy who will not be allowed to participate in the study.

Exclusion Criteria

* Patients with known hypersensitivity to any of the excipients of LDK378.
* Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
* History of carcinomatous meningitis.
* Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
* Clinically significant, uncontrolled heart disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Tumor response per RECIST v1.1 as assessed by the investigators.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Duration of response (DOR)<br /><br>- Disease control rate (DCR)<br /><br>- Time to Response (TTR)<br /><br>- Overall response rate (ORR) by assessment by a Blinded Independent Review<br /><br>Committee (BIRC)</p><br>