A phase III study of LDK378 versus standard chemotherapy in previously untreated ALK+, stage IIIB (not candidates for definitive multimodality therapy) or stage IV, non-squamous NSCLC

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222158

Enrollment

376

Registered

2013-07-30

Start date

2013-07-09

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

non-squamous non-small cell lung cancer

Interventions

LDK378 Ceritinib (LDK378) was administered orally once-daily fasted at a dose of 750 mg capsules on a continuous dosing schedule. Ceritinib was the investigational treatment and is referred to as the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patient has a histologically or cytologically confirmed diagnosis of non-squamous NSCLC that is ALK positive as assessed by the Ventana IHC test. The test will be performed at Novartis designated central laboratories. 2. Patient has newly diagnosed stage IIIB (and is not a candidate for definitive multimodality therapy) or stage IV non-squamous NSCLC or relapsed locally advanced or metastatic non-squamous NSCLC not previously treated with any systemic anti-cancer therapy (e.g. cytotoxic drugs, monoclonal antibody therapy, crizotinib or other ALK inhibitors, or other targeted therapies, either experimental or not), with exception of neoadjuvant or adjuvant therapy 3. Patient has at least one measurable lesion as defined by RECIST 1.1. A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation.

Exclusion criteria

Exclusion criteria: 1. Patient with known hypersensitivity to any of the excipients of LDK378 2. Patient with a history of severe hypersensitivity reaction to platinum containing drugs, pemetrexed or any known excipients of these drugs. 3. Patient with symptomatic CNS metastases who is neurologically unstable or has required increasing doses of steroids within the 2 weeks prior to screening to manage CNS symptoms.

Design outcomes

Primary

Measure	Time frame
PFS defined as time from date of randomization to date of first documented disease (as assessed by Blinded Independent Review Committee (BIRC) per RECIST 1.1) or date of death due to any cause	—

Countries

Australia, Austria, Brazil, China, Colombia, Denmark, France, Germany, Greece, India, Ireland, Italy, Lebanon, Mexico, Netherlands, Norway, Poland, Republic of Korea, Russia Federation, Singapore, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom

Contacts

Public ContactTakamitsu Hirano

Novartis Pharma K.K.

rinshoshiken.toroku2@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026