Active not recruitingPHASE3INTERVENTIONAL

A Study to Assess the Efficacy and Safety of Zipalertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB-IIIA NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection

This research study is for people who have had early-stage non-small cell lung cancer (NSCLC) removed by surgery. Specifically, it's for those whose cancer has a particular genetic change called an 'uncommon EGFR mutation'. The main purpose is to see how well a new drug, zipalertinib, works when given alongside standard chemotherapy, compared to standard chemotherapy with a dummy pill (placebo). Zipalertinib is designed to target these specific gene changes. The study aims to find out if this new treatment can help prevent the cancer from coming back and if it is safe to use. About 360 people will take part, being split into two groups by chance.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Taiho Oncology, Inc.

Enrolment target

360

Start

22 Dec 2025

Estimated completion

01 Oct 2032

NSCLC, Stage IB-IIIA Lung Cancer Adjuvant Post-surgical EGFR Exon 20 Early Stage Lung Cancer Uncommon EGFR Mutations

What is this study about?

This study is an important step in finding new ways to treat a specific type of lung cancer called non-small cell lung cancer (NSCLC). This cancer has already been removed by surgery and is in its early stages (Stage IB to IIIA). What makes this study special is that it focuses on people whose cancer cells have unusual changes in a gene called EGFR. These 'uncommon EGFR mutations' mean the cancer might behave differently and could respond to different treatments.

The main idea behind this study is to test a new drug called zipalertinib. This drug is designed to specifically target the cancer cells with these EGFR mutations. We want to see if adding zipalertinib to the standard chemotherapy treatment given after surgery can help prevent the cancer from returning, compared to just having standard chemotherapy with a placebo (a dummy pill). Finding more effective treatments after surgery is crucial for improving long-term health for people with this type of cancer.

About 360 people will be involved in this study. They will be randomly placed into one of two groups. One group will receive zipalertinib along with their standard chemotherapy (cisplatin or carboplatin plus pemetrexed), followed by zipalertinib alone. The other group will receive a placebo (dummy pill) with their standard chemotherapy, followed by the placebo alone. This comparison will help the researchers understand if zipalertinib is an effective and safe option for people with early-stage NSCLC and uncommon EGFR mutations.

Key takeaways

This study is for early-stage lung cancer (NSCLC) patients who have had surgery.
It's specifically for those with uncommon EGFR gene mutations in their cancer.
It compares a new drug (zipalertinib) with a dummy pill (placebo), both given alongside standard chemotherapy.
The aim is to see if zipalertinib can help prevent cancer recurrence after surgery and if it is safe.
Participation involves regular hospital visits, tests, and taking study medication (either zipalertinib or placebo).
You can stop participating at any time if you change your mind.

Who may be eligible?

To join this study, you must have had surgery to completely remove non-small cell lung cancer (NSCLC) that is in stages IB to IIIA. Your cancer must also have a specific genetic change called an 'uncommon EGFR mutation', confirmed by a local lab. You also need to have recovered well from your surgery, and the study must start between 4 to 12 weeks after your operation. Importantly, you should not have any cancer spread to your brain. If you have been diagnosed with stage IB NSCLC, your doctors need to confirm that your cancer has certain features that would make adjuvant chemotherapy recommended. You also need to be generally well and able to perform your usual daily activities without too much difficulty.

There are also reasons why you might not be able to join. For example, if you are currently taking part in another clinical trial or receiving other experimental drugs, you won't be able to participate. You will also need to provide a sample of your tumor tissue for further checks.

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.

Have you had surgery to completely remove non-small cell lung cancer?
Is your cancer in its early stages (IB, IIA, IIB, or IIIA)?
Has a lab test confirmed that your cancer has an 'uncommon EGFR mutation'?
Are you between 4 and 12 weeks post-surgery?
Are you generally well and able to carry out your daily activities?
Are you not currently involved in another clinical drug trial?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be assigned by chance to one of two treatment groups. Both groups will receive a standard chemotherapy treatment (cisplatin or carboplatin plus pemetrexed) for a set period. One group will take zipalertinib pills twice a day, every day, during and after their chemotherapy. The other group will take placebo (dummy) pills twice a day, every day, during and after their chemotherapy. The specific schedule for how long you take the pills will be explained by the study team.

You will have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how you're responding to treatment. The study team will track any side effects you might experience. The total duration of your participation in the study, including follow-up, will be clearly explained by the research team. An independent group will also regularly check the safety data from everyone taking part.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving a new experimental treatment that could be more effective at preventing the cancer from returning. However, zipalertinib is an experimental drug, meaning its full effects and side effects are not yet completely known. You may experience side effects from the chemotherapy medicines or from zipalertinib (or the placebo) that could be uncomfortable or, in rare cases, serious. The research team will carefully monitor you for any side effects and support you throughout the study. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (252)

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

Alaska Oncology and Hematology
Verified postcode
Anchorage, United States
City of Hope Comprehensive Cancer Center - Duarte
Verified postcode
Duarte, United States
City of Hope Comprehensive Cancer Center Orange County Lennar Foundation Cancer Center
Verified postcode
Irvine, United States
Scripps Clinic Torrey Pines
Verified postcode
La Jolla, United States
Kaiser Permanente - Vallejo Medical Center
Verified postcode
Vallejo, United States
Georgetown University School of Medicine
Verified postcode
Washington D.C., United States
D&H Cancer Research Center - Margate
Verified postcode
Margate, United States
Alpha Oncology Research
Verified postcode
Orange City, United States
City of Hope - Atlanta
Verified postcode
Newnan, United States
University of Illinois Medical Center
Verified postcode
Chicago, United States
Profound Research LLC at Michigan Hematology and Oncology Consultants
Verified postcode
Dearborn, United States
Henry Ford Health System
Verified postcode
Detroit, United States

Common questions

What is NSCLC?

NSCLC stands for non-small cell lung cancer, which is the most common type of lung cancer.

What is an 'EGFR mutation'?

EGFR is a gene that can sometimes change (mutate) in cancer cells. This study is for specific, less common changes in this gene.

What is zipalertinib?

Zipalertinib is a new drug being tested. It's designed to specifically target cancer cells with those particular EGFR gene changes.

Why is there a placebo group?

A placebo (dummy pill) group helps researchers fairly compare the new drug against the standard treatment to see if it's truly making a difference.

What does 'adjuvant treatment' mean?

Adjuvant treatment is extra treatment given after primary treatment (like surgery) to try and stop the cancer from coming back.