Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR Mutant Advanced NSCLC-RW

NCT06355609 | Recruiting Phase 2

• 1 other identifier: DZ2023EI004-RW
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

sunvozertinib; anlotinib; EGFR mutations

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  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

  Time from first subject dose to study completion, or up to 36 month

Secondary Outcomes (4)

• 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

• Adverse events (AEs) according to CTCAE 5.0

  From first dose until 28 days after the last dose, up to 24 month

Study Arms (1)

Treatment Group

EXPERIMENTAL

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)

Drug: sunvozertinib in combination with Anlotinib

Interventions

sunvozertinib in combination with Anlotinib DRUG

Sunvozertinib 300 mg once daily (QD) with Anlotinib 8mg once daily （QD in Day 1-14），21 days in one cycle.

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yongchang Zhang

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongchang Zhang

CONTACT

+8613873123436; zhangyongchang@csu.edu.cn

Liang Zeng

CONTACT

+8673189762327; 530490930@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 30, 2024
• First Posted: April 9, 2024
• Study Start: July 1, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2027
• Last Updated: September 20, 2024

Record last verified: 2024-09

Locations

CN (1)