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Compares treatment options for Non-small Cell Lung Cancer
Official title A Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib for First-line Treatment in EGFR-mutated, Advanced or Metastatic NSCLC
ClinicalTrials.gov ID: NCT07183189
What this study is testing
What is SHR-A2009 ; Aumolertinib?
SHR-A2009 ; Aumolertinib is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer.
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 a randomized, controlled, open-label, multicenter Phase III clinical trial designed to compare the efficacy and safety of SHR-A2009 combined with aumolertinib versus aumolertinib monotherapy in treatment-naïve subjects with EGFR-mutated, locally advanced or metastatic non-small cell lung cancer.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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
- Age 18 to 75 years (inclusive) at the time of signing informed consent, regardless of gender.
- people with histologically or cytologically confirmed locally advanced, metastatic, or recurrent non-small cell lung cancer, with EGFR mutations...
- No prior systemic therapy for locally advanced, metastatic, or recurrent non-small cell lung cancer.
- At least one measurable tumor lesion according to RECIST v1.1.
- ECOG performance status of 0 or 1.
You likely can't join if
- Histologically or cytologically confirmed combined small cell lung cancer (SCLC), neuroendocrine carcinoma, sarcomatoid carcinoma, or carcinosarcoma...
- people with a history of leptomeningeal metastasis, brainstem metastasis, or spinal cord metastasis.
- people with uncontrolled tumor-related pain, as determined by the investigator.
- Clinically uncontrolled third-space fluid accumulation, as determined by the investigator.
- Insufficient time interval between prior antitumor therapy and the first dose administration.
- Major organ surgery or significant trauma within 4 weeks prior to the first dose of the study drug.
See the full eligibility criteria
- Age 18 to 75 years (inclusive) at the time of signing informed consent, regardless of gender.
- people with histologically or cytologically confirmed locally advanced, metastatic, or recurrent non-small cell lung cancer, with EGFR mutations confirmed by tissue or blood specimens.
- No prior systemic therapy for locally advanced, metastatic, or recurrent non-small cell lung cancer.
- At least one measurable tumor lesion according to RECIST v1.1.
- ECOG performance status of 0 or 1.
- Expected survival time ≥12 weeks.
- Adequate bone marrow and organ function.
- people must provide informed consent prior to the trial and voluntarily sign a written informed consent form.
- Histologically or cytologically confirmed combined small cell lung cancer (SCLC), neuroendocrine carcinoma, sarcomatoid carcinoma, or carcinosarcoma components.
- people with a history of leptomeningeal metastasis, brainstem metastasis, or spinal cord metastasis.
- people with uncontrolled tumor-related pain, as determined by the investigator.
- Clinically uncontrolled third-space fluid accumulation, as determined by the investigator.
- Insufficient time interval between prior antitumor therapy and the first dose administration.
- Major organ surgery or significant trauma within 4 weeks prior to the first dose of the study drug.
- History of other malignancies within ≤5 years prior to the first dose.
- people with a history of interstitial lung disease, or imaging at screening suggestive of suspected interstitial lung disease; or other moderate to severe pulmonary diseases severely affecting lung function.
- Severe cardiovascular or cerebrovascular diseases.
- Any severe or uncontrolled ocular lesions that, in the physician's judgment, may increase the patient's safety risk.
- Refractory nausea, vomiting, chronic gastrointestinal diseases, etc.
- Severe infections within 4 weeks prior to the first dose.
- people with arterial/venous thromboembolic events within 6 months prior to the first dose of the study drug.
- Active tuberculosis infection.
- History of immunodeficiency, including positive HIV test.
- Active hepatitis B or hepatitis C.
- Prior allogeneic hematopoietic stem cell transplantation or organ transplantation.
- History of severe allergic reactions to aumolertinib or other monoclonal antibodies, or hypersensitivity to any component of SHR-A2009.
- Known history of alcohol or drug dependence or drug abuse.
- Psychiatric disorders or poor compliance.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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 Guangzhou, Guangdong, 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.