Trial comparing treatments 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?
An investigational oral tablet being studied as a potential treatment for advanced non‑small cell lung cancer with HER2 mutations. It is designed to block the activity of the mutated HER2 protein, which may slow cancer cell growth.
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
- This study is testing whether sevabertinib works and is safe compared with standard treatment in people with advanced non‑small cell lung cancer that has HER2 mutations.
- Who it's for
- You may be able to join if you have advanced non‑small cell lung cancer with a HER2 mutation and can take pills or get IV treatment.
- What's involved
- You will take sevabertinib tablets twice a day or receive an IV infusion every 21 days. You will have regular scans, blood and urine tests, heart checks, and answer questions about how you feel.
- Time commitment
- The study lasts until the cancer gets worse or side effects are too strong, with check‑ups every few weeks.
- 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.
- Eligible to receive treatment with the selected platinum-based doublet-chemotherapy (i.e.
You likely can't join if
- 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.
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.
- No prior systemic therapy for locally advanced or metastatic disease. No prior treatment with a HER2 ex20ins-targeted therapy (e.g. poziotinib, trastuzumab deruxtecan).
- 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.
- 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 is enrolling
- San Francisco, California, United States
- Santa Monica, California, United States
- Fort Lauderdale, Florida, United States
- Atlanta, Georgia, United States
- Columbus, Georgia, United States
- Chicago, Illinois, United States
- Cincinnati, Ohio, United States
- Maumee, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- Fortaleza, Ceará, Brazil
- Brasília, Federal District, Brazil
- Recife, Pernambuco, Brazil
- Natal, Rio Grande do Norte, Brazil
- Blumenau, Santa Catarina, Brazil
- Bauru, São Paulo, Brazil
- Jaú, São Paulo, Brazil
- São Paulo, Brazil
- Sofia, Sofia City Province, Bulgaria
- Brampton, Ontario, Canada
+ 12 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, but 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?
This study is enrolling now at San Francisco, California, United States; Santa Monica, California, United States; Fort Lauderdale, Florida, United States; Atlanta, Georgia, United States; Columbus, Georgia, United States; Chicago, Illinois, United States and 26 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.