2024-511319-91-00
Recruiting
Phase 3
(22615 SOHO-02) 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
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Bayer AG
- Enrollment
- 145
- Locations
- 117
- Primary Endpoint
- Progression free survival (PFS) per RECIST 1.1 as assessed by blinded independent central review (BICR)
Overview
Brief Summary
To evaluate the effect of BAY 2927088 compared with SoC in progression free survival (PFS)
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- Yes
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
- •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 the planned start of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.
- •Participants with active brain metastases (i.e., new brain metastases or progressive brain metastases that have not been subjected to CNS-directed therapy since documented progression) and leptomeningeal disease (i.e., positive cerebrospinal fluid cytology or unequivocal radiologic or clinical evidence of leptomeningeal involvement) are excluded. Participants with treated brain metastases that are asymptomatic at screening are eligible if all of the criteria in the protocol are met.
- •Lung-specific intercurrent clinically significant severe illness based on investigators assessment. Has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management. Lymphangitic spread of the NSCLC is not exclusionary. Past medical history of Grade ≥2 ILD, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment within the last 12 months, or any Grade active pneumonitis/interstitial lung disease.
- •Refractory nausea and vomiting, chronic gastrointestinal disorders or diseases, clinically active diverticulitis, intra-abdominal abscess, GI obstruction, abdominal carcinomatosis, malabsorption syndrome, inability to swallow the drug, or previous significant gastric/bowel resection that would preclude adequate absorption of BAY 2927088.
Outcomes
Primary Outcomes
Progression free survival (PFS) per RECIST 1.1 as assessed by blinded independent central review (BICR)
Progression free survival (PFS) per RECIST 1.1 as assessed by blinded independent central review (BICR)
Secondary Outcomes
- Overall survival (OS)
- Objective response rate (ORR) per RECIST 1.1 as assessed by BICR
- PFS per RECIST 1.1 as assessed by the investigator
- ORR per RECIST 1.1 as assessed by the investigator
- Disease control rate (DCR) per RECIST 1.1 as assessed by BICR
- DCR per RECIST 1.1 as assessed by the investigator
- Duration of response (DOR) as assessed by BICR
- DOR as assessed by the investigator
- Adverse events per CTCAE v 5.0 (eg. TEAEs, TESAEs) categorized by severity
- Change from baseline in Non-small cell lung cancer Symptom Assessment Questionnaire (NSCLC-SAQ) total score
- Change from baseline in NSCLC-SAQ individual domain scores (cough, pain, dyspnea, fatigue, appetite)
- Time to deterioration in NSCLC-SAQ total score
- Time to deterioration in NSCLC-SAQ individual domain scores (cough, pain, dyspnea, fatigue, appetite)
- Time to deterioration in EORTC QLQ-C30 physical functioning domain score
- Change from baseline in EORTC QLQ-C30 physical functioning domain score
- Change from baseine in EORTC QLQ-C30 global health status/QoL
Investigators
Therapeutic Area Head
Scientific
Bayer AG
Study Sites (117)
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