A Perspective Observation Phase II, Single-Arm Study Evaluating the 1st Line Efficacy and Safety of Sunvozertinib Plus Anlotinib in EGFR-Sensitive Mutations Combined With Co-Mutations Locally Advanced or Metastatic NSCLC
Overview
- Phase
- Phase 2
- Intervention
- sunvozertinib in combination with Anlotinib
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Hunan Province Tumor Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Progression-free survival (PFS)
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Detailed Description
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 locally advanced or metastatic primary non-small cell lung cancer with EGFR-sensitive mutations combined with co-mutations. Approximately 52 NSCLC patients with EGFR-sensitive mutations (19del, L858R and T790M) and co-mutations were enrolled and treated with sunvozertinib (300 mg once daily) in combination with anlotinib (8 mg once daily for 2 weeks, followed by a 1-week interruption) until the patients experienced disease progression, intolerable toxicity, or met the criteria for discontinuation of the trial drug. The primary endpoint was investigator-assessed PFS, and secondary endpoints included ORR, DCR, OS, and safety. The study is expected to commence recruitment in mainland China in about April 2024. It is expected that the trial will end in Dec 2027.
Investigators
Yongchang Zhang
Professor
Hunan Province Tumor Hospital
Eligibility Criteria
Inclusion 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, PIK3CA, catenin beta-1 (CTNB1), and retinoblastoma (RB1).
- •Predicted survival ≥ 12 weeks.
- •Adequate bone marrow hematopoiesis and organ function
- •Presence of measurable lesions according to RECIST 1.
- •Subjects with stable brain metastases may be included in the study.
Exclusion Criteria
- •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.
Arms & Interventions
Treatment Group
A Phase II, Single-Arm Study Evaluating the 1st Line Efficacy and Safety of Sunvozertinib plus Anlotinib in EGFR-Sensitive Mutations Combined with Co-Mutations Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Intervention: sunvozertinib in combination with Anlotinib
Outcomes
Primary Outcomes
Progression-free survival (PFS)
Time Frame: Time from first subject dose to study completion, or up to 36 month
To assess progression-free survival of patients treated by sunvozertinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as first dose to first documented disease progression assessed by investigator or death due to any cause
Secondary Outcomes
- Adverse events (AEs) according to CTCAE 5.0(From first dose until 28 days after the last dose, up to 24 month)
- Objective Response Rate (ORR)(Time from first dose to last dose, or up to 24 month)
- Overall survival (OS)(Time from first subject dose to study completion, or up to 36 month)
- Duration of Response (DoR)(Time from first subject dose to study completion, or up to 36 month)