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NCT03974022 · OUTCOME

Part A: Confirmed ORR and DCR by Independent Review Committee (IRC).

Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1) · Source last updated 2026-01-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
The study duration was from the initiation of sunvozertinib treatment until the study completion. The median study duration was 10 months, and the maximal study duration was 51.4 months for part A.

What was measured

To retrospectively assess anti-tumor activity of sunvozertinib in treatment-naive NSCLC patients with EGFR Exon20ins according to RECIST 1.1 by IRC. Confirmed ORR was defined as the percentage of patients achieving a CR or PR and was confirmed by subsequent tumor assessment at least 4 weeks within the study period. Confirmed DCR was defined as the proportion of patients with a best overall response of CR, PR, or SD. Patients who achieved a CR or PR must be confirmed by subsequent tumor assessment at least 4 weeks within the study period. Patients who achieved a best overall response of SD must be confirmed by subsequent tumor assessment at least 35 days within the study period.

Analysis population: Only participants in Part A were presented here, while Part B were presented separately. According to the clinical study protocol, only participants in Part A Dose Expansion Cohort 5 (treatment-naive patients) were evaluated by IRC. Therefore, we only present the IRC results from Part A Dose Expansion Cohort 5.

Groups in this outcome

Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal

Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal29

Reported measurements

Confirmed objective response rate
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal62.1Not reported42.379.3Not reported
Confirmed disease control rate
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal89.7Not reported72.697.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        42.3
        upper Limit
        79.3
        value
        62.1
    title
    Confirmed objective response rate
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        72.6
        upper Limit
        97.8
        value
        89.7
    title
    Confirmed disease control rate
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    units
    Participants
description
To retrospectively assess anti-tumor activity of sunvozertinib in treatment-naive NSCLC patients with EGFR Exon20ins according to RECIST 1.1 by IRC. Confirmed ORR was defined as the percentage of patients achieving a CR or PR and was confirmed by subsequent tumor assessment at least 4 weeks within the study period. Confirmed DCR was defined as the proportion of patients with a best overall response of CR, PR, or SD. Patients who achieved a CR or PR must be confirmed by subsequent tumor assessment at least 4 weeks within the study period. Patients who achieved a best overall response of SD must be confirmed by subsequent tumor assessment at least 35 days within the study period.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
    id
    OG000
    title
    Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
param Type
NUMBER
population Description
Only participants in Part A were presented here, while Part B were presented separately. According to the clinical study protocol, only participants in Part A Dose Expansion Cohort 5 (treatment-naive patients) were evaluated by IRC. Therefore, we only present the IRC results from Part A Dose Expansion Cohort 5.
reporting Status
POSTED
time Frame
The study duration was from the initiation of sunvozertinib treatment until the study completion. The median study duration was 10 months, and the maximal study duration was 51.4 months for part A.
title
Part A: Confirmed ORR and DCR by Independent Review Committee (IRC).
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice