Sunvozertinib Combined With Chemotherapy for EGFRm After EGFR-TKI Treatment Failure：Phase I/II (WU-KONG36)

Sichuan University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: Chemotherapy; Drug: Sunvozertinib

Study type: Interventional

Funder types: Other

Identifiers

NCT06195189

DZ2023EI002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Sunvozertinib combined with chemotherapy (Pemetrexed +platinum)

Experimental group

Description:

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

Treatment:

Drug: Chemotherapy

Drug: Sunvozertinib