RecruitingPhase 1/2

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

China40 participantsStarted 2024-02-29

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:

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)

What they're measuring

Objective Response Rate (ORR)

Timeframe: Time from first dose to last dose, or up to 24 month

Trial details

NCT IDNCT06195189

SponsorSichuan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-30

Contact for this trial

Li Li, BA

113880343287 tracy.li_2010@hotmail.com

View on ClinicalTrials.gov More Non Small Cell Lung Cancer trials