Active — Not RecruitingPhase 1

Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer

United States, Australia, Belgium57 participantsStarted 2015-05-27

Plain-language summary

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

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this is a Phase 1 trial combining ceritinib and nivolumab, what is currently known about the safety profile of this combination, and what side effects should I be most watchful for given that both drugs work on different parts of the immune and cancer-signaling systems?
2The trial is still working out the maximum tolerated dose of this combination — what does that mean for me in terms of how my dosing might be adjusted, and how does that uncertainty compare to what's already known about ceritinib or nivolumab used alone?
3This trial is no longer actively recruiting new patients — does that affect whether I could be considered for it, and if not, are there similar ALK-positive NSCLC trials or approved treatments I should be exploring instead?
4Since this is ALK-positive NSCLC specifically, would starting with an established ALK inhibitor like ceritinib on its own first be a better option before considering an experimental combination like this one?
5The trial is measuring overall response rate as a key outcome — based on what's been reported so far, what do you know about how well this combination has been working in patients like me, and how does that compare to standard treatment options?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion

Timeframe: Study Day 42 (6 weeks)

Overall response rate (ORR)

Timeframe: 24 Weeks

Trial details

NCT IDNCT02393625

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04-09

View on ClinicalTrials.gov More ALK-positive NSCLC trials

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.