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

Phase 1

Recruiting

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: Sunvozertinib; Drug: Chemotherapy

• Registration Number: NCT06195189
• Lead Sponsor: Sichuan University

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.

Detailed Description

This study is a single arm study 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.

Study Timeline

• Study First Submitted: 2023-12-24
• Study First Submitted QC: 2023-12-24
• Study First Posted: 2024-01-08
• Study Start: 2024-02-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-25
• Primary Completion: 2025-12-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. To provide a signed and dated, written informed consent.
2. 80≥Age ≥ 18 years old
3. Histologically or cytologically confirmed non-squamous NSCLC with documented EGFR mutations from a local laboratory
4. EGFR-sensitive mutations including exon 19 deletion and exon 21 L858R mutated, and exon 20 T790M mutated.
5. Predicted life expectancy ≥ 12 weeks
6. EGFR-TKI resistance or intolerant to standard EGFR TKIs therapy.
7. No previous systemic chemotherapy for advanced or metastatic disease.
8. Adequate organ system function:
9. Patient must have measurable disease according to RECIST 1.1.
10. Patients with stable or pre-treated brain metastasis (BM) can be enrolled

Exclusion Criteria

1. Spinal cord compression or meningeal metastasis
2. A history of malignant tumors within 2 years.
3. With known resistant mutations that have approved target therapy
4. Recover from AEs caused by previous treatment
5. A history of stroke or intracranial hemorrhage within 6 months prior to initial dosing.
6. 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sunvozertinib combined with chemotherapy (Pemetrexed +platinum)	Chemotherapy	Sunvozertinib 200mg Quaquedie (QD) combined with chemotherapy (Pemetrexed +platinum)
Sunvozertinib combined with chemotherapy (Pemetrexed +platinum)	Sunvozertinib	Sunvozertinib 200mg Quaquedie (QD) combined with chemotherapy (Pemetrexed +platinum)

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Time from first dose to last dose, or up to 24 month	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)

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DoR)	Time from first subject dose to study completion, or up to 36 month	To assess duration of response for subjects with CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator , defined as the time from the first documented CR or PR to disease progression or death
Progression-free survival (PFS)	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
Overall survival (OS)	Time from first subject dose to study completion, or up to 36 month	To assess overall survival, define as first dose to the death of the subject due to any cause
Adverse events (AEs) according to CTCAE 5.0	From first dose until 28 days after the last dose, up to 24 month	Number of participants with adverse events (AEs) according to CTCAE 5.0

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Si Chuan, China