Sunvozertinib Treatment in Untreated Advanced NSCLC With EGFR Uncommon Mutations (WU-KONG35)

Fudan University

Status and phase: Enrolling; Phase 2

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: sunvozertinib 200mg; Drug: sunvozertinib 300mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07117890

SUM-NSCLC-01

Details and patient eligibility

About

This study is a single arm study to access the anti-tumor efficacy and safety of sunvozertinib in untreated advanced NSCLC patients with EGFR uncommon mutations.

Enrollment: 34 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥18 years old
2. histologically or cytologically confirmed non-squamous NSCLC with documented EGFR uncommon mutations from a local laoratory. at least one EGFR uncommon mutation (excluding EGFR 19del/l858r/T790m/Ex 20ins ) or compund mutations with EGFR uncommon mutations.
3. predicted life expectancy ≥ 12 weeks.
4. patient must have measurable disease according to RECIST 1.1

Exclusion criteria

1. previos systemic anti-tumor therapy
2. a history of malignant tumors within 2years
3. any severa or poorly controlled systemic disease per investigator's judgement
4. active infections

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Sunvozertinib 300mg

Experimental group

Description:

sunvozertinib monotherapy, 300mg QD

Treatment:

Drug: sunvozertinib 300mg

sunvozertinib 200mg

Experimental group

Description:

sunvozertinib monotherapy, 200mg QD

Treatment:

Drug: sunvozertinib 200mg