OncoMatch/Clinical Trials/NCT06348927
Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR-Sensitive Mutations Combined With Co-Mutations Advanced NSCLC
Is NCT06348927 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies sunvozertinib in combination with Anlotinib for non-small cell lung cancer.
Treatment: sunvozertinib in combination with Anlotinib — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR exon 19 deletion
EGFR-sensitive mutations confirmed by an accredited local laboratory, including exon 19 deletions, exon 21 L858R point mutations, and T790M mutations
Required: EGFR L858R
EGFR-sensitive mutations confirmed by an accredited local laboratory, including exon 19 deletions, exon 21 L858R point mutations, and T790M mutations
Required: EGFR T790M
EGFR-sensitive mutations confirmed by an accredited local laboratory, including exon 19 deletions, exon 21 L858R point mutations, and T790M mutations
Required: TP53 mutation
co-mutations, including but not limited to TP53, PIK3CA, catenin beta-1 (CTNB1), and retinoblastoma (RB1)
Required: PIK3CA mutation
co-mutations, including but not limited to TP53, PIK3CA, catenin beta-1 (CTNB1), and retinoblastoma (RB1)
Required: CTNNB1 mutation
co-mutations, including but not limited to TP53, PIK3CA, catenin beta-1 (CTNB1), and retinoblastoma (RB1)
Required: RB1 mutation
co-mutations, including but not limited to TP53, PIK3CA, catenin beta-1 (CTNB1), and retinoblastoma (RB1)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Prior systemic therapy for locally advanced or metastatic disease
Cannot have received: EGFR antibody
Exception: within 4 weeks prior to the first dose
Treatment with molecules such as EGFR, VEGFR antibodies within 4 weeks prior to the first dose of study drug
Cannot have received: VEGFR antibody
Exception: within 4 weeks prior to the first dose
Treatment with molecules such as EGFR, VEGFR antibodies within 4 weeks prior to the first dose of study drug
Cannot have received: radiation therapy
Exception: within 14 days prior to the first dose or 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.
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.
Lab requirements
Blood counts
Adequate bone marrow hematopoiesis
Kidney function
Adequate organ function
Liver function
Adequate organ function
Adequate bone marrow hematopoiesis and organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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