NL-OMON44906
Completed
Not Applicable
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) (CLDK378A2120C) - CLDK378A2120C
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- non small cell lung cancer
- Sponsor
- ovartis
- Enrollment
- 3
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Female and male patients \* 18 years of age.
- •\* Relapsed locally advanced or metastatic NSCLC with an ALK\-rearrangement.
- •\* Measurable disease.
- •\* Clinically and neurologically stable CNS metastases who have not required increasing doses of steroids or stable doses \> 10 mg daily prednisone equivalent within 2 weeks prior to study entry to manage CNS symptoms.
- •\* In the expansion phase, patients must have received prior treatment according to the following: Arm 1: ALK inhibitor\-treated, ALK inhibitor: Yes, Chemotherapy: 0 or 1 prior courses, Prior treatment with any ALK inhibitor except ceritinib is allowed.
- •Arm 2: ALK inhibitor\-naïve ALK inhibitor: No, Chemotherapy: 0 or 1 prior courses.
- •\* WHO performance status 0 or 1\.
Exclusion Criteria
- •\* Severe hypersensitivity reactions to other monoclonal antibodies.
- •\* Prior treatment with anti\-PD1/anti\-PD\-L1 agents.
- •\* Chronic systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \>10 mg daily prednisone equivalent, are permitted to enroll in the absence of active autoimmune disease.
- •\* Clinically significant, uncontrolled heart disease and/or recent cardiac event. See protocol page 14 for details.
- •\* (History of) interstitial lung disease.
- •\* Comedications listed on page 14 of the protocol.
- •\* Pregnancy, lactation, inadequate contraception (males and females). See protocol page 15 for details.
Outcomes
Primary Outcomes
Not specified
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