NCT06195189 Sunvozertinib Combined With Chemotherapy for EGFRm After EGFR-TKI Treatment Failure：Phase I/II
| NCT ID | NCT06195189 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Sichuan University |
| Condition | Non Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-02-29 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2024-02-29 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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)
Contact & Investigator
You Lu, MD
PRINCIPAL INVESTIGATOR
West China Hospital
Frequently Asked Questions
Who can join the NCT06195189 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Non Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06195189 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06195189 currently recruiting?
Yes, NCT06195189 is actively recruiting participants. Contact the research team at tracy.li_2010@hotmail.com for enrollment information.
Where is the NCT06195189 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT06195189 clinical trial?
NCT06195189 is sponsored by Sichuan University. The principal investigator is You Lu, MD at West China Hospital. The trial plans to enroll 40 participants.
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