A phase III multicenter, randomized study of oral LDK378 versus standard chemotherapy in previously untreated adult patients with ALK rearranged (ALK-positive), stage IIIB or IV, non-squamous non-small cell lung cancer

Phase 3

Completed

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

Registration Number: NL-OMON55921

Lead Sponsor: ovartis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

- Histologically or cytologically confirmed diagnosis of non-squamous NSCLC
that is ALK positive
- Newly diagnosed stage IIIB or IV NSCLC or relapsed locally advanced or
metastatic NSCLC not previously treated with any systemic anti-cancer therapy
- 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.

Exclusion Criteria

- Patient is currently receiving treatment with coumarin-derivative
anticoagulants.
- Patient with symptomatic CNS metastases.
- Patient has history of interstitial lung disease or interstitial pneumonitis
- Patient has received thoracic radiotherapy to lung fields <= 4 weeks prior to
starting the study treatment. For all other anatomic sites radiotherapy <= 2
weeks 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>determined by a Blinded Independent Review Committee (BIRC)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The key secondary objective is to compare overall survival in patients treated<br /><br>with LDK378 versus reference chemotherapy<br /><br>Other secondary objectives are:<br /><br>- to assess the antitumor activity of LDK378 versus reference chemotherapy, as<br /><br>measured by overall response rate, duration of response, disease control rate,<br /><br>and time to response determined by BIRC and by investigators<br /><br><br /><br>- To assess the antitumor activity of LDK378 versus reference chemotherapy, as<br /><br>measured by PFS determined by investigators<br /><br><br /><br>- To evaluate the safety profile of LDK378 versus reference chemotherapy<br /><br><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><br /><br>- To characterize the PK of LDK378 in this patient population</p><br>