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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2026-02-01

Brief Summary

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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.

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Detailed Description

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This study is a single arm study 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.

Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sunvozertinib combined with chemotherapy (Pemetrexed +platinum)

Sunvozertinib 200mg Quaquedie (QD) combined with chemotherapy (Pemetrexed +platinum)

Group Type EXPERIMENTAL

Sunvozertinib

Intervention Type DRUG

Sunvozertinib 200mg Quaquedie (QD)

Chemotherapy

Intervention Type DRUG

Pemetrexed +platinum

Interventions

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Sunvozertinib

Sunvozertinib 200mg Quaquedie (QD)

Intervention Type DRUG

Chemotherapy

Pemetrexed +platinum

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No