Ceritinib + Nivolumab for Non-Small Cell Lung Cancer

Recruiting at 11 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Novartis Pharmaceuticals

Disqualifiers: Other cancers, Autoimmune diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

57 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

This trial is for adults with ALK-positive Non-Small Cell Lung Cancer (NSCLC) who may have had previous cancer treatments but recovered from most side effects. They should have at least one measurable tumor and be in good physical condition (WHO performance status 0-1). People with other recent cancers, autoimmune diseases, difficulty swallowing pills, or severe medical conditions can't participate.

Inclusion Criteria

You have at least one visible and measurable tumor as defined by specific guidelines.

I have recovered from side effects of previous cancer treatments, except for mild neuropathy, hair loss, tiredness, nail or skin changes.

My lung cancer is ALK-positive.

Exclusion Criteria

You have a known or suspected autoimmune disease that is currently active.

I cannot or do not want to swallow pills.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ceritinib in combination with nivolumab

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Ceritinib
• Nivolumab

Trial Overview The study is testing the combination of two drugs: Ceritinib and Nivolumab, to see how safe and effective they are together for treating NSCLC patients with an ALK rearrangement. It's an open-label trial which means everyone knows what treatment they're getting.

Participant Groups

Group I: Dose Expansion Experimental Treatment 2 Interventions

Group II: Dose Escalation Experimental Treatment 2 Interventions

Ceritinib is already approved in United States for the following indications:

Approved in United States as Danyelza for:

• High-risk neuroblastoma in the bone or bone marrow

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD