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NCT03974022 · OUTCOME

Part B: Objective Response Rate (ORR) According to RECIST 1.1 by an 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
97.5% Confidence Interval
Time frame
through the study completion, an average of around 1 year for part B

What was measured

To evaluate anti-tumor activity of Sunvozertinib in advanced NSCLC patients with EGFR Exon20 insertion at defined dose(s) by assessment of Objective Response Rate (ORR).

Groups in this outcome

Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg

Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized to receive sunvozertinib 200 mg once daily continuously.

Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg

Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized ratio to receive sunvozertinib 300 mg once daily 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 B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg85
Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg107

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 97.5% Confidence Interval
GroupValueSpreadLowerUpperComment
Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg45.9Not reported33.658.5Not reported
Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg45.8Not reported34.857.0Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    statistical Method
    binomial exact test against H0
  2. group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    statistical Method
    binomial exact test against H0
Complete source fields
analyses
  1. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    statistical Method
    binomial exact test against H0
  2. group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    statistical Method
    binomial exact test against H0
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        33.6
        upper Limit
        58.5
        value
        45.9
      2. group Id
        OG001
        lower Limit
        34.8
        upper Limit
        57.0
        value
        45.8
denoms
  1. counts
    1. group Id
      OG000
      value
      85
    2. group Id
      OG001
      value
      107
    units
    Participants
description
To evaluate anti-tumor activity of Sunvozertinib in advanced NSCLC patients with EGFR Exon20 insertion at defined dose(s) by assessment of Objective Response Rate (ORR).
dispersion Type
97.5% Confidence Interval
groups
  1. description
    Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized to receive sunvozertinib 200 mg once daily continuously.
    id
    OG000
    title
    Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg
  2. description
    Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized ratio to receive sunvozertinib 300 mg once daily continuously.
    id
    OG001
    title
    Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg
param Type
NUMBER
reporting Status
POSTED
time Frame
through the study completion, an average of around 1 year for part B
title
Part B: Objective Response Rate (ORR) According to RECIST 1.1 by an Independent Review Committee (IRC).
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice