Ceritinib + Nivolumab for Non-Small Cell Lung Cancer

Not currently recruiting at 14 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment combination for people with ALK-positive non-small cell lung cancer (NSCLC). Researchers aim to determine if the drugs ceritinib (a targeted therapy) and nivolumab (an immunotherapy) work well together and are safe for patients. The trial has two parts: one to find the best dose and another to test it further. Suitable participants have advanced ALK-positive NSCLC with at least one measurable tumor and have recovered from side effects of previous treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ceritinib has been tested in individuals with ALK-positive non-small cell lung cancer (NSCLC). Some studies have found that taking ceritinib with food can be gentler on the stomach, reducing stomach-related side effects like nausea and diarrhea, particularly at lower doses.

Nivolumab has already received approval for treating other cancers, but serious side effects, such as infections, have been reported in a small number of patients.

This trial tests a combination of ceritinib and nivolumab, so using them together might cause different side effects than when each drug is used alone. As this is an early-phase study, the primary goal is to learn more about the safety of this combination. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Ceritinib and Nivolumab for non-small cell lung cancer because they bring a fresh approach to treatment. Unlike traditional chemotherapy, which targets rapidly dividing cells indiscriminately, Ceritinib specifically inhibits a protein called ALK, which is involved in cancer cell growth and survival. Nivolumab, on the other hand, is an immunotherapy that helps the immune system recognize and attack cancer cells by blocking a protein called PD-1. This dual action not only targets cancer cells more precisely but also boosts the body’s natural defenses, offering a promising alternative to existing treatments.

What evidence suggests that ceritinib and nivolumab could be effective for non-small cell lung cancer?

This trial will evaluate the combination of ceritinib and nivolumab for patients with ALK-positive non-small cell lung cancer (NSCLC). Studies have shown that using ceritinib and nivolumab together can be promising. Ceritinib blocks a protein that aids cancer cell growth, while nivolumab enhances the immune system's ability to fight cancer. Research indicates that some patients experienced a lasting response, with tumors shrinking or stopping growth for a significant time. Previous patients with NSCLC have benefited from this combination, suggesting it might be effective. While results can vary, early signs are promising for those with this specific type of lung cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1556086419335646

Ceritinib plus Nivolumab in Patients with Advanced ALK- ... Ceritinib plus Nivolumab in Patients with Advanced ALK-Rearranged Non–Small Cell Lung Cancer: Results of an Open-Label, Multicenter, Phase 1B Study. Author ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2017.35.15_suppl.2502

Ceritinib plus nivolumab (NIVO) in patients (pts) with ... Ceritinib in advanced anaplastic lymphoma kinase (ALK)-rearranged (ALK+) non-small cell lung cancer (NSCLC): Results of the ASCEND-1 trial.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4975160/

New targeted treatments for non-small-cell lung cancer About one in four to one in five patients experienced durable objective response (OR), in particular those with melanoma, NSCLC, and renal cell cancer. Given ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10026098/

Efficacy of immunotherapy in oncogene-driven non-small- ... This article reviews the clinical data on ICIs for each of the driver oncogene defined lung cancer subtypes, including efficacy, both for ICI as ...

5. researchgate.net researchgate.net/publication/336655032_Ceritinib_plus_Nivolumab_in_Patients_with_Advanced_ALK-Rearranged_Non-Small_Cell_Lung_Cancer_Results_of_an_Open-Label_Multicenter_Phase_1B_Study

Ceritinib plus Nivolumab in Patients with Advanced ALK- ... In this prospective phase 2 study, we evaluated the activity of ceritinib in alectinib‐pretreated patients with anaplastic lymphoma kinase (ALK) ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26973324/

Activity and safety of ceritinib in patients with ALK-rearranged ... Activity and safety of ceritinib in patients with ALK-rearranged non-small-cell lung cancer (ASCEND-1): updated results from the multicentre, open-label, phase ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02393625

NCT02393625 | Study of Safety and Efficacy of Ceritinib in ... 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.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35344649/

Efficacy and Safety of Ceritinib 450 mg/day with Food and ... Asian patients with ALK+ advanced/metastatic NSCLC treated with ceritinib 450-mg fed showed numerically higher efficacy and lower GI toxicity than 750-mg ...

9. nejm.org nejm.org/doi/full/10.1056/NEJMoa1311107

Ceritinib in ALK-Rearranged Non–Small-Cell Lung Cancer Safety data are summarized for all the patients who received at least one dose of ceritinib. Efficacy data are summarized for all the ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT02299505

Study Details | NCT02299505 | Pharmacokinetic and ... A Phase I study to assess the systemic exposure, effiacy, and safety of 450 mg ceritinib taken with a low-fat meal and 600 mg ceritinib taken with a low-fat ...