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
Eligibility
Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion — Study Day 42 (6 weeks)
Overall response rate (ORR) — 24 Weeks ORR (complete response (CR)+ partial response (PR)) per RECIST 1.1 as assessed by investigator
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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