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NCT01625234 · OUTCOME

Number of Participants With Preliminary Tumor Response in ALK Positive Patients at 225 mg QD

Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer · Source last updated 2026-04-30

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

Measure
NUMBER
Unit
participants
Interval / dispersion
95% Confidence Interval
Time frame
18 months

What was measured

To explore the preliminary clinical tumor response after treatment with X-396 (ensartinib) given as a single agent in ALK positive patients at 225 mg QD. Subjects were assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria (and CNS lesions were also assessed by modified Response Assessment in Neuro-Oncology). Assessments by CT or MRI were performed after every even cycle of treatment. All assessments were to be performed within 7 days of the scheduled day of assessment. Tumor lesions followed on physical examination must have been assessed on Day 1 of each cycle and at the End-of-Study Treatment Visit.

Analysis population: The Tumor response evaluation population (Recommended Phase 2 Dose only) consisted of subjects who were ALK+ at 225 mg QD, completed at least 1 cycle of treatment, and had a post-baseline response assessment.

Groups in this outcome

X-396 (Ensartinib) 225 mg

RP2D 225 mg For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations. Phase II: X-396 (ensartinib): Expanded Cohort

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

Analysis denominator · Participants

GroupSource count
X-396 (Ensartinib) 225 mg81

Reported measurements

Source class 1
Values in participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
X-396 (Ensartinib) 225 mg34Not reported31.153.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        31.1
        upper Limit
        53.5
        value
        34
denoms
  1. counts
    1. group Id
      OG000
      value
      81
    units
    Participants
description
To explore the preliminary clinical tumor response after treatment with X-396 (ensartinib) given as a single agent in ALK positive patients at 225 mg QD. Subjects were assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria (and CNS lesions were also assessed by modified Response Assessment in Neuro-Oncology). Assessments by CT or MRI were performed after every even cycle of treatment. All assessments were to be performed within 7 days of the scheduled day of assessment. Tumor lesions followed on physical examination must have been assessed on Day 1 of each cycle and at the End-of-Study Treatment Visit.
dispersion Type
95% Confidence Interval
groups
  1. description
    RP2D 225 mg For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations. Phase II: X-396 (ensartinib): Expanded Cohort
    id
    OG000
    title
    X-396 (Ensartinib) 225 mg
param Type
NUMBER
population Description
The Tumor response evaluation population (Recommended Phase 2 Dose only) consisted of subjects who were ALK+ at 225 mg QD, completed at least 1 cycle of treatment, and had a post-baseline response assessment.
reporting Status
POSTED
time Frame
18 months
title
Number of Participants With Preliminary Tumor Response in ALK Positive Patients at 225 mg QD
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice