Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR-Sensitive Mutations Combined With Co-Mutations Advanced NSCLC

Recruiting now · Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

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

Key facts

Study ID: NCT06348927
Run by: Hunan Province Tumor Hospital
People needed: 52
Starts: 2024-07-01
Expected to finish: 2027-04-30
Last updated by the study team: 2024-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 mutations, combined with co-mutations, including but not limited to TP53, PIK3CA, catenin beta-1 (CTNB1), and retinoblastoma (RB1).
ECOG 0 - 1.
Predicted survival ≥ 12 weeks.
Adequate bone marrow hematopoiesis and organ function
Presence of measurable lesions according to RECIST 1.1.
Subjects with stable brain metastases may be included in the study.

You may not qualify if…

Prior systemic therapy for locally advanced or metastatic disease.
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.
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.
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.
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 immunotherapy.
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.

Where it is running

Hunan Cancer Hospital — Changsha, Hunan, China (enrolling)

Full record on ClinicalTrials.gov

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