Sunvozertinib Combined With Chemotherapy for EGFRm After EGFR-TKI Treatment Failure：Phase I/II
Recruiting · NCT06195189 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
ChemotherapySunvozertinib
What this trial is 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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- To provide a signed and dated, written informed consent.
- 80≥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
Exclusion criteria
- 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)
Where it is running
1 location listed.
- West China Hospital of Sichuan University - Chengdu, Sichuan, China