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

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 - ASCEND-4: LDK378 vs chemo in untreated patients with ALK+ lung cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55921

Enrollment

Registered

2013-05-31

Start date

2013-12-17

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced non-small cell lung cancer advanced NSCLC

Interventions

Treatment with LDK378

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The primary objective is to compare the antitumor activity of LDK378 versus reference chemotherapy, as measured by progression free survival (PFS) determined by a Blinded Independent Review Committee (BIRC)	—

Secondary

Measure	Time frame
The key secondary objective is to compare overall survival in patients treated with LDK378 versus reference chemotherapy Other secondary objectives are: - to assess the antitumor activity of LDK378 versus reference chemotherapy, as measured by overall response rate, duration of response, disease control rate, and time to response determined by BIRC and by investigators - To assess the antitumor activity of LDK378 versus reference chemotherapy, as measured by PFS determined by investigators - To evaluate the safety profile of LDK378 versus reference chemotherapy - To assess the effect of LDK378 versus reference chemotherapy on patient reported outcomes (PRO), including disease related symptoms, functioning, and health-related quality of life - To characterize the PK of LDK378 in this patient population	—

Measure

Time frame

The key secondary objective is to compare overall survival in patients treated with LDK378 versus reference chemotherapy Other secondary objectives are: - to assess the antitumor activity of LDK378 versus reference chemotherapy, as measured by overall response rate, duration of response, disease control rate, and time to response determined by BIRC and by investigators - To assess the antitumor activity of LDK378 versus reference chemotherapy, as measured by PFS determined by investigators - To evaluate the safety profile of LDK378 versus reference chemotherapy - To assess the effect of LDK378 versus reference chemotherapy on patient reported outcomes (PRO), including disease related symptoms, functioning, and health-related quality of life - To characterize the PK of LDK378 in this patient population

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)