Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Subcutaneous Methotrexate, Oral Dexamethasone or Oral Montelukast for the Prevention of Infusion Related Reaction Associated with Amivantamab, an EGFR-MET bispecific antibody, Among Post-osimertinib Treated EGFRm NSCLC; SKIPPirr, a Phase 2 Study

This study, called SKIPPirr, is for people with a specific type of advanced lung cancer. They have a form of lung cancer with changes in their EGFR gene and have already been treated with a medicine called osimertinib. The main goal is to find out if certain medications given by mouth or injection can stop or reduce side effects called 'infusion reactions.' These reactions can happen when new cancer medicines, JNJ-73841937 and JNJ-61186372 (also known as amivantamab), are given through a drip. Researchers are comparing montelukast, dexamethasone, and methotrexate as ways to prevent these reactions. The study will mainly look at infusion reactions that occur on the very first day of treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Janssen - Cilag International

Enrolment target

Start

31 Jan 2024

EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer

What is this study about?

This study, known as SKIPPirr, is looking for better ways to help people with a type of lung cancer deal with their treatment. Specifically, it's for those with 'non-small cell lung cancer' that has spread (advanced or metastatic) and has a particular genetic change called an 'EGFR mutation.' These patients have usually already tried a medicine called osimertinib.

The main treatment being studied involves two new medicines, JNJ-73841937 and JNJ-61186372 (also called amivantamab), which will be given together. Amivantamab is given through a drip, and sometimes when medicines are given this way, people can have an 'infusion-related reaction.' These reactions can feel a bit like an allergic reaction, with symptoms like rash, itching, or feeling unwell. This study wants to find out if giving other medicines *before* the main cancer drug can stop or lessen these reactions.

Researchers are comparing three different preventative medicines: Montelukast tablets, Dexamethasone tablets, and Methotrexate injections. They want to see which, if any, is best at preventing these infusion reactions, particularly those that happen on the very first day the main treatment is given. By finding a good way to prevent these reactions, patients might have a smoother experience with their cancer treatment.

Key takeaways

Targets advanced lung cancer (EGFR-mutated, post-osimertinib).
Aims to prevent infusion reactions from new cancer drugs.
Tests three different preventative medications.
Specifically watches for reactions on the first day of treatment.
A Phase 2 study, meaning it's exploring effectiveness and safety.
Could help make cancer treatment easier to tolerate.

Who may be eligible?

To join this study, you must be at least 18 years old. Both men and women can take part. You have to have a specific type of lung cancer called 'non-small cell lung cancer' that has spread to other parts of your body (advanced or metastatic).

Additionally, your cancer must have a particular genetic change called an 'EGFR mutation.' You should also have previously been treated with a medicine called osimertinib for your lung cancer.

There might be other health requirements that the study team will discuss with you to make sure the study is a safe and suitable option for your unique situation.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have advanced or metastatic non-small cell lung cancer?
Does your lung cancer have an EGFR gene mutation?
Have you already received treatment with osimertinib for your lung cancer?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will likely receive either a tablet (Montelukast or Dexamethasone) or a small injection (Methotrexate) before you get the main cancer treatment. The main cancer treatment involves two drugs, JNJ-73841937 (lazertinib) given by mouth and JNJ-61186372 (amivantamab) given through a drip.

The study will pay close attention to any reactions you have on the first day of your amivantamab drip. You'll have regular appointments to monitor your health, check for side effects, and see how the treatment is working. The study team will explain the full schedule of visits, how long you'll be on the treatment, and any follow-up appointments once the main treatment ends. The total duration of your participation will depend on how you respond to the treatment and the study's specific design.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. A potential benefit of this study is that you might receive a treatment that could help manage your lung cancer, and you might also receive medication that could reduce potential side effects from the cancer treatment. However, there's always a chance that the treatments might not work for you, or they could cause side effects. Some side effects might be mild, while others could be more serious. The medicine used to prevent reactions (like Methotrexate, Montelukast, or Dexamethasone) also have their own potential risks and side effects. All possible side effects will be fully explained to you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France
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Unverified
Spain

Common questions

What kind of cancer is this study for?

This study is for advanced non-small cell lung cancer with a specific genetic change called an EGFR mutation.

Why is this study being done?

It's being done to find out if certain medicines can prevent or reduce allergic-like reactions when new cancer drugs are given through a drip.

What kind of treatments will I receive?

You'll receive two main cancer drugs and also a preventative medicine (either Montelukast, Dexamethasone, or Methotrexate) before the drip treatment.

What are 'infusion reactions'?

These are side effects that can happen when medicine is given through a drip, like a rash, itching, or feeling unwell.

How long will I be in the study?

The study team will explain the exact duration, which depends on your response and the study's plan.