NCT06348927 Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR-Sensitive Mutations Combined With Co-Mutations Advanced NSCLC
| NCT ID | NCT06348927 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hunan Province Tumor Hospital |
| Condition | Non-Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 52 participants in total. It began in 2024-07-01 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: 1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form. 2. Age ≥ 18 years. 3. Histopathology or cytology confirmed and recorded local progression or metastatic non-small cell lung cancer without systemic treatment. 4. 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, PIK3CA, catenin beta-1 (CTNB1), and retinoblastoma (RB1). 5. ECOG 0 - 1. 6. Predicted survival ≥ 12 weeks. 7. Adequate bone marrow hematopoiesis and organ function 8. Presence of measurable lesions according to RECIST 1.1. 9. Subjects with stable brain metastases may be included in the study. Exclusion Criteria: 1. Prior systemic therapy for locally advanced or metastatic disease. 2. Subjects 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 radiotherapy may be performed 7 days prior to the first dose. * 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. 3. Presence of spinal cord compression or meningeal metastasis. 4. History of other malignant tumors within 2 years. 5. 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. 6. History of stroke or intracranial hemorrhage within 6 months prior to the first dose. 7. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator. 8. Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection. 9. Heart-related diseases or abnormalities 10. 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 immunotherapy. 11. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection. 12. Live vaccine was given 2 weeks before the first medication. 13. Women who are breastfeeding or pregnant. 14. Hypersensitivity to the test drug and the ingredients. 15. Other conditions assessed by the investigator to be unsuitable for participation in the study.
Contact & Investigator
Yongchang Zhang
PRINCIPAL INVESTIGATOR
Hunan Cancer Hospital
Frequently Asked Questions
Who can join the NCT06348927 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06348927 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06348927 currently recruiting?
Yes, NCT06348927 is actively recruiting participants. Contact the research team at zhangyongchang@csu.edu.cn for enrollment information.
Where is the NCT06348927 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT06348927 clinical trial?
NCT06348927 is sponsored by Hunan Province Tumor Hospital. The principal investigator is Yongchang Zhang at Hunan Cancer Hospital. The trial plans to enroll 52 participants.
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