A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

Conditions

• Advanced Non-small Cell Lung Cancer, HER2 Mutation

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sevabertinib — DRUG
  Tablet, oral
• Pembrolizumab — DRUG
  Intravenous (IV) infusion
• Cisplatin — DRUG
  IV infusion
• Carboplatin — DRUG
  IV infusion
• Pemetrexed — DRUG
  IV infusion

Study Details

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations. Advanced NSCLC means lung cancer that has spread nearby or to other parts of the body or is unlikely to be controlled with current treatments. HER2 is a protein that helps cells to grow and divide. Sometimes, cancer cells have a damaged HER2 gene. This is called a mutation. This mutation can lead to an abnormal HER2 protein which may cause cancer cells to grow and divide too quickly. The study treatment, sevabertinib, is designed to block the mutated HER2 protein and may help slow or stop the cancer from growing. The main purpose of this study is to find out how well sevabertinib works and how safe it is, compared with standard treatment in participants with advanced NSCLC with a HER2 mutation. The study participants will receive one of the study treatments: * Sevabertinib as a tablet taken by mouth twice a day * Standard approved treatment for this condition given by infusion into a vein every 21 days Participants will continue their assigned treatment for as long as they benefit from it and do not experience severe side effects, or until they or their doctor decide to stop treatment. When a participant assigned to the standard treatment has their cancer gets worse, they may have the opportunity to switch to receive sevabertinib. This switch is called a crossover. Participants who switch to sevabertinib will continue this treatment until their disease gets worse again, they have side effects that are too severe, or they or their doctor decide to stop treatment. During the study, the research team will: * do scans such as CT, PET, MRI, or X-rays to check the cancer * Check the overall health of the participants by performing tests such as blood and urine tests and checking heart health using an electrocardiogram and echocardiogram. * do pregnancy tests when needed * ask how the participants are feeling and whether they have had any adverse events or other health problems An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.

Key Dates

First listed

Jun 11, 2024

Start date

Aug 28, 2024

Status verified

Jul 2026

Primary completion

Oct 28, 2027

Completion

Jun 27, 2029

Study Design

Enrollment

444 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Sevabertinib
  Participants will receive sevarbetinib 20 mg BID until disease progression per RECIST v1.1, unacceptable toxicity, or until any other withdrawal criteria.
• Active Comparator: Standard of care (SoC)
  Participants will receive SoC (pembrolizumab in combination with platinum-based chemotherapy, in 21-day cycles per the approved labels) until disease progression per RECIST v1.1, unacceptable toxicity, or until any other withdrawal criteria. Participants in the SoC arm will have the opportunity to crossover to receive sevabertinib when they experience disease progression.

Primary Outcome Measure

Progression free survival (PFS) per RECIST 1.1 as assessed by BICR [ Time Frame: Up to approximately 2 years ]

Central Contacts

• Bayer Clinical Trials Contact
  18888422937
  [email protected]

Locations (24)

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