A phase III, multicenter, randomized, open-label study of oral LDK378 versus standard chemotherapy in adult patients with ALK-rearranged (ALK-positive) advanced non-small cell lung cancer who have been treated previously with chemotherapy (platinum doublet) and crizotinib

Phase 3

Completed

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

Registration Number: NL-OMON47784

Lead Sponsor: ovartis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 7

Inclusion Criteria

- Histologically or cytologically confirmed diagnosis of non-squamous NSCLC
that is ALK positive
- Stage IIIB or IV NSCLC or relapsed locally advanced or metastatic NSCLC
- At least one measurable lesion as defined by RECIST 1.1.
- 18 years of age or older
- Life expectancy * 12 weeks
- WHO performance status 0-2.
- Patients must have received previous treatment with crizotinib
- Patients must have received one regimen of platinum- doublet, cytotoxic
chemotherapy

Exclusion Criteria

- Patients who where previously treated witn ALK-inhibitors (with the exception
of crizotinib)
- Patient is currently receiving treatment with coumarin-derivative
anticoagulants.
- Patient with symptomatic CNS metastases.
- Patient has received radiotherapy * 2 weeks or * 4 weeks for thoracal
radiotherapy prior to starting the study treatment or has not recovered from
radiotherapy-related toxicities.
- Patient has had major surgery within 4 weeks prior (2 weeks for resection of
brain metastases) to starting study treatment or has not recovered from side
effects of such procedure.
- Patient with a concurrent malignancy or history of a malignant disease other
than NSCLC that has been diagnosed and/or required therapy within the past 3
years.
- Patient has clinically significant, uncontrolled heart disease and/or recent
cardiac event (within 6 months)
- Patient is pregnant or nursing (lactating) woman

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is to compare the antitumor activity of LDK378 versus<br /><br>reference chemotherapy, as measured by progression free survival (PFS).<br /><br>The key secondary objective is to compare Overall Survival (OS) in patients<br /><br>treated with LDK378 versus reference chemotherapy (pemetrexed or docetaxel).<br /><br>Measured by RECIST 1.1.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the antitumor activity of LDK378 versus reference chemotherapy, as<br /><br>measured by overall response rate (ORR), duration of response (DOR), disease<br /><br>control rate (DCR), and time to response (TTR)<br /><br>To evaluate the safety profile of LDK378 versus reference chemotherapy<br /><br>(physical examination, haematology, biochemistry, urinalysis, sex hormones<br /><br>(males only), coagulation, vital signs, ECG, pregnancy test<br /><br>To assess the effect of LDK378 versus reference chemotherapy on patient<br /><br>reported outcomes (PRO), including disease related symptoms, functioning, and<br /><br>health-related quality of life<br /><br>To characterize the pharmacokinetics (PK) of LDK378</p><br>