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)

Completed

• Conditions: non small cell lung cancer; 10029107; lung cancer

• Registration Number: NL-OMON44906
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 3

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>DLT, objective response rate.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Adverse events. DOR, DCR, TR, PFS, OS.</p><br>