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Compares treatment options for Advanced Non-small Cell Lung Cancer, HER2 Mutation
Official title 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)
ClinicalTrials.gov ID: NCT06452277
What this study is testing
What is Sevabertinib?
Sevabertinib is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced non-small cell lung cancer, her2 mutation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations. 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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...
- Documented histologically or cytologically confirmed locally advanced non-squamous NSCLC, not suitable for definitive therapy or metastatic...
- Documented activating HER2 mutation in the tyrosine kinase domain (TKD) assessed by tissue molecular test in a CLIA-certified (US sites) or an...
- No prior systemic therapy for locally advanced or metastatic disease. No prior treatment with a HER2 ex20ins-targeted therapy (e.g. poziotinib...
- Eligible to receive treatment with the selected platinum-based doublet-chemotherapy (i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and...
You likely can't join if
- Known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence...
- 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.
See the full eligibility 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)...
- 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...
- 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...
- 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.
- 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...
- 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...
- 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 study team makes the final eligibility decision.
Where it's taking place
- Newport Beach, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Santa Monica, California, United States
- Fort Lauderdale, Florida, United States
- Miramar, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Columbus, Georgia, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Worcester, Massachusetts, United States
- Farmington Hills, Michigan, United States
- Royal Oak, Michigan, United States
- Minneapolis, Minnesota, United States
- New Hyde Park, New York, United States
- Cincinnati, Ohio, United States
- Maumee, Ohio, United States
- Portland, Oregon, United States
+ 212 more site(s).
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newport Beach, California, United States; San Diego, California, United States; San Francisco, California, United States; Santa Monica, California, United States; Fort Lauderdale, Florida, United States; Miramar, Florida, United States and 226 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 ClinicalTrials.gov; the study team decides eligibility.