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New treatment option for Non-Small Cell Lung Cancer
Official title Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR-Sensitive Mutations Combined With Co-Mutations Advanced NSCLC
ClinicalTrials.gov ID: NCT06348927
What this study is testing
What is sunvozertinib in combination with Anlotinib?
sunvozertinib in combination with Anlotinib is an investigational medicine, given as an once-daily, 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 is a phase II, open-label, single-arm, single-center clinical study to evaluate the preliminary efficacy of sunvozertinib in combination with anlotinib in patients with EGFR-sensitive mutations and co-mutations in locally advanced or metastatic treatment-naive non-small cell lung cancer. Condition or disease Intervention/treatment Phase Non-Small Cell Lung Cancer Drug: sunvozertinib Drug: anlotinib Phase 2
- Phase 2: a mid-size study of how well it works
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
- Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
- Age ≥ 18 years.
- Histopathology or cytology confirmed and recorded local progression or metastatic non-small cell lung cancer without systemic treatment.
- EGFR-sensitive mutations confirmed by an accredited local laboratory, including exon 19 deletions, exon 21 L858R point mutations, and T790M...
- ECOG 0 - 1.
You likely can't join if
- Prior systemic therapy for locally advanced or metastatic disease.
- people who have received any of the following treatments must be excluded:
- Treatment with molecules such as EGFR, VEGFR antibodies within 4 weeks prior to the first dose of study drug.
- Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain...
- Ongoing (or inability to discontinue) possibly potent CYP1A2, CYP3A inhibitor (1 week), or inducer (2 weeks) drug therapy or herbal supplements...
- Presence of spinal cord compression or meningeal metastasis.
See the full eligibility criteria
- Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
- Age ≥ 18 years.
- Histopathology or cytology confirmed and recorded local progression or metastatic non-small cell lung cancer without systemic treatment.
- EGFR-sensitive mutations confirmed by an accredited local laboratory, including exon 19 deletions, exon 21 L858R point mutations, and T790M mutations, combined with co-mutations, including but not limited to TP53...
- ECOG 0 - 1.
- Predicted survival ≥ 12 weeks.
- Adequate bone marrow hematopoiesis and organ function
- Presence of measurable lesions according to RECIST 1.1.
- people with stable brain metastases may be included in the study.
- Prior systemic therapy for locally advanced or metastatic disease.
- people who have received any of the following treatments must be excluded:
- Treatment with molecules such as EGFR, VEGFR antibodies within 4 weeks prior to the first dose of study drug.
- Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body...
- Ongoing (or inability to discontinue) possibly potent CYP1A2, CYP3A inhibitor (1 week), or inducer (2 weeks) drug therapy or herbal supplements within 1-2 weeks prior to the first dose.
- Presence of spinal cord compression or meningeal metastasis.
- History of other malignant tumors within 2 years.
- Adverse events (except alopecia of any degree) of CTCAE \> grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.
- History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
- The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.
- people with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection.
- Heart-related diseases or abnormalities
- Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by...
- Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection.
- Live vaccine was given 2 weeks before the first medication.
- Women who are breastfeeding or pregnant.
- Hypersensitivity to the test drug and the ingredients.
- Other conditions assessed by the investigator to be unsuitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, Hunan, 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.