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New treatment option for Non-Small Cell Lung Cancer With HER2- Mutations
Official title A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations
ClinicalTrials.gov ID: NCT06430437
What this study is testing
What is SHR-A1811?
SHR-A1811 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer with her2- mutations.
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
- The study is being conducted to evaluate the efficacy, and safety of SHR-A1811 versus Standard of Care as first-line treatment of advanced or metastatic Non-Small Cell Lung Cancer with HER2- Mutations
- 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 to 75
You may be able to join if
- Able and willing to provide a written informed consent
- 18-75 years old (inclusive of both ends)
- ECOG score of 0 or 1.
- Patients with histologically or cytologically confirmed advanced or metastatic NSCLC.
- people with central laboratory- confirmed functional HER2 mutations
You likely can't join if
- Mixed lung cancer with small cell components and sarcomatoid carcinoma confirmed by histology or cytology.
- Concurrently carrying other driver gene mutations, and targeted drugs for such driver gene mutations have been approved for market release.
- people with untreated or active metastasis of central nervous system (CNS) tumors, or a history of meningeal metastasis or current meningeal...
- With poorly controlled tumor-related pain.
- previous or current with other malignancies.
- people with a history of interstitial pneumonia/non-infectious pneumonia requiring hormone therapy, or current interstitial pneumonia/non-infectious...
See the full eligibility criteria
- Able and willing to provide a written informed consent
- 18-75 years old (inclusive of both ends)
- ECOG score of 0 or 1.
- Patients with histologically or cytologically confirmed advanced or metastatic NSCLC.
- people with central laboratory- confirmed functional HER2 mutations
- No prior systemic antitumor therapy (including investigational agents) for advanced or metastatic NSCLC.
- Have at least one measurable lesion outside the central nervous system that meets the criteria defined by RECIST v1.1
- Protocol-defined adequate organ function including cardiac, renal, hepatic function
- Mixed lung cancer with small cell components and sarcomatoid carcinoma confirmed by histology or cytology.
- Concurrently carrying other driver gene mutations, and targeted drugs for such driver gene mutations have been approved for market release.
- people with untreated or active metastasis of central nervous system (CNS) tumors, or a history of meningeal metastasis or current meningeal metastasis.
- With poorly controlled tumor-related pain.
- previous or current with other malignancies.
- people with a history of interstitial pneumonia/non-infectious pneumonia requiring hormone therapy, or current interstitial pneumonia/non-infectious pneumonia.
- people with active or previous autoimmune diseases.
- people with uncontrolled or severe cardiovascular diseases.
- people with active hepatitis B or hepatitis C.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. 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.