RecruitingPhase 1Phase 2NCT06195189

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

Sunvozertinib Combined With Chemotherapy for EGFRm + Locally Advanced or Metastasis NSCLC Patients After EGFR-TKI Treatment Failure:Phase I/II (WU-KONG36)


Sponsor

Sichuan University

Enrollment

40 participants

Start Date

Feb 29, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a drug called sunvozertinib, combined with standard chemotherapy, can help people with non-small cell lung cancer (NSCLC) whose tumors have a specific genetic mutation (EGFR) and have stopped responding to previous targeted therapy. **You may be eligible if...** - You are 18–80 years old - You have non-squamous NSCLC with an EGFR mutation (exon 19 deletion, L858R, or T790M) - Your cancer has become resistant to or you cannot tolerate standard EGFR-targeted therapy - You have not had chemotherapy for advanced or metastatic disease - You have measurable tumors on imaging - Brain metastases are allowed if stable or previously treated **You may NOT be eligible if...** - You have spinal cord compression or cancer spread to the membranes around the brain - You have had another cancer within the past 2 years - You have had a stroke or brain bleed within the last 6 months - You have poorly controlled infections including hepatitis B, C, or HIV Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSunvozertinib

Sunvozertinib 200mg Quaquedie (QD)

DRUGChemotherapy

Pemetrexed +platinum


Locations(1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

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NCT06195189


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