Sunvozertinib Combined With Chemotherapy for EGFRm After EGFR-TKI Treatment Failure：Phase I/II
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sunvozertinib, Chemotherapy.
- Who it may be relevant to
- Registry conditions: Non Small Cell Lung Cancer. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sunvozertinib Combined With Chemotherapy for EGFRm + Locally Advanced or Metastasis NSCLC Patients After EGFR-TKI Treatment Failure：Phase I/II (WU-KONG36)
Overview
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.
Detailed description
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.
Interventions
- Drug Sunvozertinib
Sunvozertinib 200mg Quaquedie (QD) - Drug Chemotherapy
Pemetrexed +platinum
Primary outcome measures
- Objective Response Rate (ORR) [Time frame: Time from first dose to last dose, or up to 24 month]
Secondary outcome measures (4)
- Duration of Response (DoR) [Time frame: Time from first subject dose to study completion, or up to 36 month]
- Progression-free survival (PFS) [Time frame: Time from first subject dose to study completion, or up to 36 month]
- Overall survival (OS) [Time frame: Time from first subject dose to study completion, or up to 36 month]
- Adverse events (AEs) according to CTCAE 5.0 [Time frame: From first dose until 28 days after the last dose, up to 24 month]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- West China Hospital of Sichuan University — Chengdu
Identifiers
NCT: NCT06195189 · DZ2023EI002