Zongertinib for Lung Cancer

Recruiting at 169 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Boehringer Ingelheim

Must not be taking: Investigational drugs

Disqualifiers: Mixed histology, Radiation therapy, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1-3 years

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is open to adults 18 years and older who have early-stage non-small cell lung cancer (NSCLC). Their cancer must have a specific change in a gene called HER2. Genes provide the instructions for making proteins, and this change leads to a faulty HER2 protein. People can join if their lung cancer was removed by surgery, and they have already received certain other anti-cancer treatments. The purpose of this study is to find out if a study medicine called zongertinib helps people with this type of cancer live longer without their cancer coming back after surgery, when compared to standard treatment. Zongertinib is being developed to target the faulty HER2 protein, which can cause cancer cells to grow.

In this study, participants are assigned by chance to one of two treatment groups, with an equal chance of being in either group. One group takes the study medicine, zongertinib, by mouth once a day for up to 3 years. The other group receives a standard treatment, chosen by their doctor. This standard treatment may be an immunotherapy medicine given by infusion into a vein every 3 or 4 weeks for up to 1 year, or regular check-ups without active study medicine (observation).

Participants can be in this study for up to about 11 years. During this time, they visit the study site regularly for check-ups and study-related tests. The frequency of these visits varies depending on their treatment and how long they have been in the study. In addition to visits at the study site, participants in some treatment groups will also have phone calls with the study team every 3 weeks to check on their health between their scheduled visits.

Doctors check for any signs of cancer coming back using imaging scans (like CT or MRI scans); these scans are generally done every 3 months for the first 2 years, then every 6 months for the next 3 years, and then yearly. Participants also fill in questionnaires about their overall wellbeing, health and symptoms. Throughout the study, doctors also check participants' health and note any unwanted effects.

Are You a Good Fit for This Trial?

Adults over 18 with early-stage non-small cell lung cancer (NSCLC) that's been surgically removed can join. They must have a specific HER2 gene mutation and completed certain anti-cancer treatments. The trial isn't suitable for those who don't meet these genetic or treatment history criteria.

Inclusion Criteria

I am 18 years old or older.

I have signed the consent form for this trial.

I am using highly effective birth control methods if capable of becoming pregnant.

Exclusion Criteria

Any investigational drug within 5 half-lives of the compound or any of its related material, if known

History or presence of - Active or known pre-existing or history of non-infectious interstitial lung disease/pneumonitis - Active infectious disease requiring systemic therapy - Uncontrolled gastrointestinal disorders affecting drug intake/absorption - Previous or concomitant malignancies within the last 3 years, except certain effectively treated cancers - Significant and/or uncontrolled cardiovascular abnormalities, QT interval corrected for heart rate by Fridericia formula (QTcF) >470 msec, or ejection fraction <50%

My lung cancer has neuroendocrine features.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either zongertinib by mouth once a day for up to 3 years or standard treatment, which may include immunotherapy every 3 or 4 weeks for up to 1 year or observation

1-3 years

Regular visits for check-ups and study-related tests, phone calls every 3 weeks

Follow-up

Participants are monitored for disease-free survival and adverse events, with imaging scans every 3 months for the first 2 years, then every 6 months for the next 3 years, and then yearly

up to 8 years and 5 months

Regular imaging scans and health assessments

Long-term follow-up

Participants continue to be monitored for long-term outcomes and overall wellbeing

up to 11 years

What Are the Treatments Tested in This Trial?

Interventions

• Zongertinib

Trial Overview The trial tests if zongertinib, targeting the faulty HER2 protein, prevents cancer return post-surgery compared to standard treatments like immunotherapy or observation. Participants are randomly assigned to take zongertinib orally daily for up to 3 years or receive standard care.

How Is the Trial Designed?

Group I: Zongertinib treatment arm Experimental Treatment 1 Intervention

Group II: Standard of Care (SoC) treatment arm Active Control 4 Interventions

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+