LDK378 in Patients With ALK Positive NSCLC Previously Treated With Alectinib.
Condition: Non-Small-Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: LDK378
Intervention description: Oral LDK378 750mg once daily
Intervention MeSH terms: Ceritinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-Small-Cell Lung Cancer; NSCLC; ALK; LDK378; alectinib; Non-small cell lung carcinoma (NSCLC); lung cancer; lung adenocarcinoma; Non small cell lung carcinoma; Non small cell lung cancer; Non-small cell lung cancer

Summary:

      This was a single-arm, open-label, multicenter, phase II study to evaluate the efficacy and
      safety of the ALK inhibitor LDK378 when used as single agent in patients with ALK-rearranged
      stage IIIB or IV NSCLC previously treated with alectinib. Treatment with LDK378 750 mg qd
      continued until the patient experienced disease progression as determined by the investigator
      according to RECIST 1.1, unacceptable toxicity that precluded further treatment, pregnancy,
      start of a new anticancer therapy, discontinued treatment at the discretion of the patient or
      investigator, lost to follow-up, death, or study was terminated by Sponsor.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Histologically or cytologically confirmed diagnosis of Stage IIIb or IV NSCLC that
             carries an ALK rearrangement as determined locally by Vysis ALK Break Apart FISH Probe
             Kit (Abbott Molecular Inc.) test.

          -  Patients must have NSCLC that has progressed at study enrollment.

          -  Patients must have received previous treatment with alectinib for treatment of locally
             advanced or metastatic NSCLC. Prior therapy with crizotinib as ALK inhibitor therapy
             in addition to alectinib is allowed. Alectinib doesn't need to be the last therapy
             prior to study enrollment. No particular sequence of prior alectinib and crizotinib is
             required for enrollment.

          -  Patients must be chemotherapy-naïve or have received only one line of prior cytotoxic
             chemotherapy.

          -  Age 18 years or older at the time of informed consent.

        Key Exclusion Criteria:

          -  Patients with known hypersensitivity to any of the excipients of LDK378.

          -  Prior therapy with other ALK inhibitor investigational agents except crizotinib and
             alectinib.

          -  Prior systemic anti-cancer (including investigational) therapy aside from alectinib,
             crizotinib and one regimen of previous cytotoxic chemotherapy for locally advanced or
             metastatic NSCLC.

          -  Patients with symptomatic central nervous system (CNS) metastases who are
             neurologically unstable or have required increasing doses of steroids within the 2
             weeks prior to study entry to manage CNS symptoms.

          -  Patient with history of interstitial lung disease or interstitial pneumonitis,
             including clinically significant radiation pneumonitis.

          -  Patients with history of carcinomatous meningitis.

          -  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)