Clinical Trials /

Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer

NCT02393625

Description:

This is an open label multi center trial to determine the safety and efficacy of ceritinib in combination with nivolumab in ALK-positive NSCLC patients

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer
  • Official Title: A Multi-center, Open-label Study to Assess the Safety and Efficacy of Combination Ceritinib (LDK378) and Nivolumab in Adult Patients With Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC)

Clinical Trial IDs

  • ORG STUDY ID: CLDK378A2120C
  • NCT ID: NCT02393625

Conditions

  • ALK-positive NSCLC

Interventions

DrugSynonymsArms
Ceritinib (LDK378)Dose Escalation
NivolumabDose Escalation

Purpose

This is an open label multi center trial to determine the safety and efficacy of ceritinib in combination with nivolumab in ALK-positive NSCLC patients

Trial Arms

NameTypeDescriptionInterventions
Dose EscalationExperimental
  • Ceritinib (LDK378)
  • Nivolumab
Dose ExpansionExperimental
  • Ceritinib (LDK378)
  • Nivolumab

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically or cytologically confirmed diagnosis of NSCLC that carries an ALK
             rearrangement

          -  Stage IIIB or IV NSCLC or relapsed locally advanced or metastatic NSCLC

          -  Presence of at least one measurable lesion as defined by RECIST 1.1

          -  Patients who have received prior chemotherapy, other ALK inhibitors, biologic therapy,
             or other investigational agents, must have recovered from all toxicities related to
             prior anticancer therapies to grade ≤1 (CTCAE v 4.03). Patients with grade ≤ 2
             peripheral neuropathy or any grade of alopecia, fatigue, nail changes or skin changes
             are allowed to enter the study

          -  Patient has a WHO performance status 0-1

        Exclusion Criteria:

          -  Presence or history of a malignant disease other than NSCLC that has been diagnosed
             and/or required therapy within the past 3 years

          -  Patients with an active, known or suspected autoimmune disease

          -  Unable or unwilling to swallow tablets or capsules

          -  Patient has other severe, acute, or chronic medical conditions including uncontrolled
             diabetes mellitus or psychiatric conditions or laboratory abnormalities that in the
             opinion of the Investigator may increase the risk associated with study participation,
             or that may interfere with the interpretation of study results
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion
Time Frame:Study Day 42 (6 weeks)
Safety Issue:
Description:ORR (complete response (CR)+ partial response (PR)) per RECIST 1.1 as assessed by investigator

Secondary Outcome Measures

Measure:Duration of Response (DOR)
Time Frame:24 weeks
Safety Issue:
Description:
Measure:Disease Control Rate (DCR)
Time Frame:24 weeks
Safety Issue:
Description:
Measure:Time to Response (TTR)
Time Frame:24 weeks
Safety Issue:
Description:
Measure:Progression Free Survival (PFS)
Time Frame:24 weeks
Safety Issue:
Description:
Measure:Overall survival (OS)
Time Frame:24 weeks
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Novartis Pharmaceuticals

Trial Keywords

  • NSCLC, ALK-positive

Last Updated