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Clinical Trials List

Protocol Number22615
NCT Number(ClinicalTrials.gov Identfier)NCT06452277
Active

2024-09-01 - 2029-02-05

Phase III

Not yet recruiting4

Recruiting4

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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

  • Trial Applicant

    BAYER TAIWAN COMPANY LTD.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/06/17

Investigators and Locations

Principal Investigator TSUNG -YING YANG 無
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 蕭聖諺 無
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chih-Jen Yang Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator James Chih-Hsin Yang 無
National Taiwan University Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Gee-chen Chang 無
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Hui Lee
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Advanced Non-small Cell Lung Cancer, HER2 Mutation

Objectives

The aim of this trial was to evaluate the efficacy and safety of BAY 2927088 compared to standard system (SoC) as a first-line therapy in patients with HER2 activating mutations in locally advanced or metastatic non-small cell lung cancer (NSCLC). 1. Primary Trial Objective • Evaluate the efficacy of BAY 2927088 compared to Standard Care (SoC) in progression-free survival (PFS) 2. Key Secondary Trial Objectives • Evaluate the efficacy of BAY 2927088 compared to SoC in overall survival (OS) • Evaluate the efficacy of BAY 2927088 compared to SoC in objective response rate (ORR) 3. Other Secondary Trial Objectives • Evaluate the efficacy of BAY 2927088 compared to SoC in progression-free survival (PFS) • Further investigate the efficacy of BAY 2927088 compared to SoC • Evaluate the safety and tolerability of BAY 2927088 compared to SoC • Evaluate patient reports (PROs) of BAY 2927088 compared to SoC

Test Drug

Tablets
Injections
Injections
Injections
Injections

Active Ingredient

BAY 2927088
1013005400
1004002410
1004001500
1012000800

Dosage Form

110
270
270
270
270

Dosage

10 mg / tab
15 mg / tab
100mg/4ml
500mg/ 20ml
450mg/ 45ml
100mg/ 100ml

Endpoints

• PFS assessed by a blinded central independent review committee (BICR) using the Responsive Criteria for Solid Tumor Response version 1.1 (RECIST 1.1).

Inclution Criteria

Inclusion Criteria:

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 Criteria

Exclusion Criteria:

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.

The Estimated Number of Participants

  • Taiwan

    12 participants

  • Global

    278 participants

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