Sunvozertinib Combined With Chemotherapy for EGFRm After EGFR-TKI Treatment Failure：Phase I/II

NCT06195189 | Recruiting Phase 1

• 1 other identifier: DZ2023EI002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To access the anti-tumor efficacy, safety and tolerability of Sunvozertinib combined with chemotherapy in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) sensitizing mutations who have progressed following standard TKI therapy.

Conditions

Non Small Cell Lung Cancer

Keywords

Non Small Cell Lung Cancer; Sunvozertinib; EGFR; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  To assess sunvozertinib overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) or a partial response (PR)

  Time from first dose to last dose, or up to 24 month

Secondary Outcomes (4)

• Duration of Response (DoR)

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

• Progression-free survival (PFS)

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

• Overall survival (OS)

  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)

Sunvozertinib combined with chemotherapy (Pemetrexed +platinum)

EXPERIMENTAL

Sunvozertinib 200mg Quaquedie (QD) combined with chemotherapy (Pemetrexed +platinum)

Drug: Sunvozertinib; Drug: Chemotherapy

Interventions

Sunvozertinib DRUG

Sunvozertinib 200mg Quaquedie (QD)

Sunvozertinib combined with chemotherapy (Pemetrexed +platinum)

Chemotherapy DRUG

Pemetrexed +platinum

Sunvozertinib combined with chemotherapy (Pemetrexed +platinum)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To provide a signed and dated, written informed consent.
• ≥Age ≥ 18 years old
• Histologically or cytologically confirmed non-squamous NSCLC with documented EGFR mutations from a local laboratory
• EGFR-sensitive mutations including exon 19 deletion and exon 21 L858R mutated, and exon 20 T790M mutated.
• Predicted life expectancy ≥ 12 weeks
• EGFR-TKI resistance or intolerant to standard EGFR TKIs therapy.
• No previous systemic chemotherapy for advanced or metastatic disease.
• Adequate organ system function:
• Patient must have measurable disease according to RECIST 1.1.
• Patients with stable or pre-treated brain metastasis (BM) can be enrolled

You may not qualify if:

• Spinal cord compression or meningeal metastasis
• A history of malignant tumors within 2 years.
• With known resistant mutations that have approved target therapy
• Recover from AEs caused by previous treatment
• A history of stroke or intracranial hemorrhage within 6 months prior to initial dosing.
• Any severe or poorly controlled systemic disease per investigator's judgment active infections, including but not limited to hepatitis B (HBV), hepatitis C (HCV), and human immunodeficiency (HIV)

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• You Lu, MD

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Li, BA

CONTACT

113880343287; tracy.li_2010@hotmail.com

Feifei Na, MD

CONTACT

18583988151; nafeifei@foxmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Department of Thoracic Oncology

Study Record Dates

• First Submitted: December 24, 2023
• First Posted: January 8, 2024
• Study Start: February 29, 2024
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)