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Recruitment on holdLast updated: 10 July 2026

SOHO-02: Targeted therapy (BAY 2927088) is compared with standard treatment in people with advanced non-small cell lung cancer who have HER2 mutationsA Phase 3 Open-label, Randomized, Active-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Orally Administered BAY 2927088 Compared With Standard of Care as a First-line Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With HER2-activating Mutations

Trial purpose

Medical clipboardCancer treatment

Tumor type

Lung Cancers Lung cancer

Age

People18+

Trial acronym

SOHO-02

Clinical summary

Summary

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called a HER2 mutation.

Advanced NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body or that are unlikely to be cured or controlled with currently available treatments.

HER2 is a protein that helps cells to grow and divide. A damage (also called mutation) to the building plans (genes) for this protein in cancer cells leads to a production of abnormal HER2 and therefore abnormal cell growth and division.

The study drug, sevabertinib, is a targeted therapy. It works by blocking the abnormal HER2 protein, which may help slow down or stop the cancer from growing.

Who can participate?
People may be eligible if they:

  • have locally advanced or metastatic non-squamous NSCLC with a HER2 mutation
  • have not received prior systemic treatment for advanced or metastatic disease.

Prior treatment at an earlier stage may be allowed if completed at least 12 months before joining the study. Patients should speak with their doctor or the study team to confirm eligibility.

About this study
The aim of the study is to compare how well sevabertinib works, and how safe it is compared with the current standard treatment.

Participants in this study will be randomly assigned (by chance) to one of two treatment groups:

  • Sevabertinib, taken as a tablet by mouth twice a day, or
  • Standard treatment, which includes chemotherapy and immunotherapy given through a drip (IV) every 3 weeks.

Participants will continue treatment for as long as it is helping and side effects are manageable. If the cancer worsens while on standard treatment, participants may have the option to switch to sevabertinib.

During the study, participants will:

  • have scans (such as CT, MRI, or PET scans) to monitor the cancer
  • have regular blood and urine tests to check overall health
  • have their heart function checked
  • be asked how they are feeling and about any side effects

A side effect (also called an adverse event) is any health problem that happens during the study, whether or not it is related to the treatment.

Conditions

This trial is treating people with advanced non-small cell lung cancer with HER2 mutations who have not received prior systemic treatment for their locally advanced or metastatic disease

Eligibility

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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body (localised).
  • You are able to swallow medication by mouth.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

Bayer

Scientific Title

A Phase 3 Open-label, Randomized, Active-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Orally Administered BAY 2927088 Compared With Standard of Care as a First-line Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With HER2-activating Mutations

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