A phase III study of LDK378 versus standard chemotherapy in ALK+ advanced NSCLC patients who have been previously treated with chemotherapy and crizotinib

JRCT ID: jRCT2080222222

Registered date:11/09/2013

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Non small cell lung cancer
• Date of first enrollment: 19/09/2013
• Target sample size: 231
• Countries of recruitment: United States,Belgium,Canada,France,Germany,Hong Kong,Ireland,Israel,Italy,Republic of Korea,Lebanon,Netherlands,Portugal,Russian Federation,Singapore,Spain,Switzerland,Turkey
• Study type: Interventional

Intervention(s)

LDK378
Ceritinib is the investigational treatment and is referred to as the investigational study drug and was provided as 150 mg hard gelatin capsules for oral use. The dose was 750 mg once daily.

Pemetrexed
Pemetrexed was one of the chemotherapy treatments. Pemetrexed, a reconstituted solution, was intravenously administered over 10 minutes at 500 mg/m2 every 21 days.

Docetaxel
Docetaxel was one of the chemotherapy treatments. Docetaxel, a reconstituted solution, was intravenously administered over 1 hour, at 75 mg/m2 every 21 days.

Outcome(s)

• Primary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patient has a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive as assessed by the FDA approved Abbott FISH Test.
2. Patient has stage IIIB or IV diagnosis and must have received one or two prior regimens (including platinum- doublet) of cytotoxic chemotherapy for the treatment of locally advanced or metastatic NSCLC.
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
4. Patients must have received previous treatment with crizotinib for the treatment of locally advanced or metastatic NSCLC.

Exclude criteria

1. Patient with known hypersensitivity to any of the excipients of LDK378 (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate)
2. Patient with a history of severe hypersensitivity reaction to pemetrexed or docetaxel or any known excipients of these drugs.
3. Patient with symptomatic central nervous system (CNS) metastases who is neurologically unstable or has required increasing doses of steroids within the 2 weeks prior to screening to manage CNS symptoms.

Related Information

• Primary Sponsor: Novartis Pharma. K.K.
• Secondary Sponsor: -
• Source(s) of Monetary Support: -
• Secondary ID(s): NCT01828112,JapicCTI-132269