Real-world Study of Sunvozertinib Treatment in Advanced EGFR-Mutant NSCLC After EGFR-TKI Treatment Failure

NCT06786208 | Not Yet Recruiting

• 1 other identifier: 2024-388
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Observe the efficacy and safety of sunvozertinib in the real world in the treatment of EGFRm aNSCLC patients with previous EGFR-TKI treatment

Conditions

Non Small Cell Lung Cancer

Keywords

Non Small Cell Lung Cancer; Sunvozertinib; EGFR

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  assess the proportion of subjects who have a complete response (CR) or a partial response (PR)\]

  Time from first dose to last dose, up to 24 month

Secondary Outcomes (2)

• Progression-free survival (PFS)

  Time from first dose to first documented disease progression assessed by investigator or death due to any cause up to 24 month

• Overall survival (OS)

  Time Frame: Time from first dose to the death of the subject due to any cause assessed up to 36 months.

Study Arms (1)

sunvozertinib treatment cohort

Patients: locally advanced or metastatic NSCLC with EGFR-sensitive mutations who have been previously treated with EGFR-TKIs and PD for last therapy. Investigators will assess patients whether to be suitable for sunvozertinib treatment. And this study will evaluate the safety and efficacy.

Drug: Sunvozertinib

Interventions

Sunvozertinib DRUG

sunvozertinb, a EGFR-TKI, 300mg QD oral

sunvozertinib treatment cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Locally advanced or metastatic NSCLC with EGFR-sensitive mutations who have been previously treated with EGFR-TKIs and PD for last therapy can be involved in this study. Investigators will assess patients whether to be suitable for sunvozertinib treatment.

You may qualify if:

• To provide a signed and dated, written informed consent.
• 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，at least one line chemotherapy and progress again
• Predicted life expectancy ≥ 12 weeks
• Adequate organ system function:
• Patient must have measurable disease according to RECIST 1.1. -

You may not qualify if:

• Spinal cord compression or meningeal metastasis
• Not Recover from AEs caused by previous treatment yet
• 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

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Qiming Wang

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 22, 2025
• Study Start: February 1, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 22, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)