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

Non Small Cell Lung Cancer Clinical Trial

— WU-KONG36  

Official title:

Sunvozertinib Combined With Chemotherapy for EGFRm + Locally Advanced or Metastasis NSCLC Patients After EGFR-TKI Treatment Failure：Phase I/II (WU-KONG36)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06195189
• Other study ID #: DZ2023EI002
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 29, 2024
• Est. completion date: February 1, 2026

Study information

• Verified date: March 2024
• Source: Sichuan University
• Contact: Li Li, BA
• Phone: 113880343287
• Email: tracy.li_2010[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

Drug:
• Sunvozertinib
Sunvozertinib 200mg Quaquedie (QD)
• Chemotherapy
Pemetrexed +platinum

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Si Chuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of Response (DoR)	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	Time from first subject dose to study completion, or up to 36 month
Secondary	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	Overall survival (OS)	To assess overall survival, define as first dose to the death of the subject due to any cause	Time from first subject dose to study completion, or up to 36 month
Secondary	Adverse events (AEs) according to CTCAE 5.0	Number of participants with adverse events (AEs) according to CTCAE 5.0	From first dose until 28 days after the last dose, up to 24 month