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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)
EU CTIS ID: 2024-511319-91-00
What this study is testing
To evaluate the effect of sevabertinib compared with SoC in progression free survival (PFS)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Known history of prior malignancy other than the one treated in this study 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.
See the full eligibility criteria
Who can join
- 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.
What rules you out
- Known history of prior malignancy other than the one treated in this study 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.
- Οι συμμετέχοντες με ενεργές εγκεφαλικές μεταστάσεις (δηλαδή, νέες εγκεφαλικές μεταστάσεις ή εγκεφαλικές μεταστάσεις με πρόοδο νόσου που δεν έχουν υποβληθεί σε στοχευμένη θεραπεία ΚΝΣ μετά την τεκμηριωμένη πρόοδο νόσου) και/ή λεπτομηνιγγική νόσο (δηλ. θετική κυτταρολογία εγκεφαλονωτιαίου υγρού ή αναμφισβήτητες ακτινολογικές ή κλινικές ενδείξεις λεπτομηνιγγικής συμμετοχής) εξαιρούνται. Οι συμμετέχοντες με εγκεφαλικές μεταστάσεις που έχουν υποβληθεί σε θεραπεία και είναι ασυμπτωματικές κατά τον προκαταρκτικό έλεγχο είναι επιλέξιμοι εάν πληρούνται όλα τα κριτήρια του πρωτοκόλλου.
- 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, any grade 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 sevabertinib.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Hong Kong
- United States
- China
- Switzerland
- Taiwan
- Australia
- Malaysia
- Israel
- Japan
- Brazil
- Korea, Republic of
- Mexico
- Singapore
- Turkey
- United Kingdom
- Ukraine
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Hong Kong; United States; China; Switzerland; Taiwan and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.