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

• Status: Recruiting
• Trial end date: 2026-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sichuan University

Criteria

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)