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Study of Sevabertinib for Advanced HER2-Mutated Non-Small Cell Lung Cancer

This study is looking for a better way to treat advanced non-small cell lung cancer (NSCLC) that has specific genetic changes called HER2 mutations. HER2 mutations can cause cancer cells to grow abnormally. The study is testing a drug called sevabertinib, which is designed to block the mutated HER2 protein and potentially stop cancer growth. You may be eligible if you are 18 or older, have advanced non-squamous NSCLC with a HER2 mutation, and meet other criteria. Researchers will compare how well sevabertinib works and how safe it is against standard treatments like pembrolizumab, cisplatin, carboplatin, or pemetrexed. The main goal is to see how long people live without their cancer getting worse, measured for up to about two years.

Study design
This interventional study plans to enroll 444 participants. It is comparing sevabertinib to standard treatments for advanced HER2-mutated non-small cell lung cancer.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, progression-free survival, is measured for up to approximately two years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06452277

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)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Bayer
~444 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:SevabertinibPembrolizumabCisplatinCarboplatinPemetrexed

At a glance

Recruiting sites
63 of 270 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival (PFS) per RECIST 1.1 as assessed by BICR
Measured over Up to approximately 2 years

Conditions

Advanced Non-small Cell Lung Cancer, HER2 Mutation

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

270 sites across 135 states
Italy15
Spain9
Greece8
Taiwan8
Ukraine8
Romania7
Poland6
Turkey (Türkiye)6

Who to contact

Bayer Clinical Trials Contact
[email protected]
18888422937
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participant must be ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signing the informed consent.
Documented histologically or cytologically confirmed locally advanced non-squamous NSCLC, not suitable for definitive therapy or metastatic non-squamous NSCLC at screening (small cell or mixed histologies are excluded) (Stage III-IV NSCLC).
Documented activating HER2 mutation in the tyrosine kinase domain (TKD) assessed by tissue molecular test in a CLIA-certified (US sites) or an equally accredited (outside of the US) local laboratory. However, participants may be included at the discretion of the investigator if the laboratory performing the assay is not CLIA or similar certified but the laboratory is locally accredited.
No prior systemic therapy for locally advanced or metastatic disease. No prior treatment with a HER2 ex20ins-targeted therapy (e.g. poziotinib, trastuzumab deruxtecan). Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the start of screening.
Eligible to receive treatment with the selected platinum-based doublet-chemotherapy (i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and pembrolizumab in accordance with the SmPC/Product Information.

Exclusion

Known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for five years since initiation of that therapy. Exception: the following cancer types are acceptable within five years if curatively treated or under surveillance:
a. in situ cancers of cervix, breast, or skin,
b. superficial bladder cancer (Ta, Tis and T1),
c. limited-stage prostate cancer,
d. basal or squamous cancers of the skin.
Tumors with targetable alterations with approved available therapy, with the exception of HER2 mutation in the TKD.
Inability to discontinue treatment with chronic systemic corticosteroids. Participants who require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study. Replacement therapy (e.g., physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is acceptable, provided that the dose is stable for \>4 weeks prior to planned start of study intervention.
Pre-existing peripheral neuropathy that is Grade ≥2 by CTCAE (v5.0).
History of severe hypersensitivity reaction to treatment with a monoclonal antibody.
Prior radiotherapy outside of the brain within 21 days before of planned start of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.

What this trial measures

  • Progression free survival (PFS) per RECIST 1.1 as assessed by BICRUp to approximately 2 years

    RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BICR = blinded independent central review (BICR)