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Ensatinib Treat Second-generation ALK-TKI Resistance After Second-generation ALK-TKI Resistance

NCT05178511 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-01-05

No results posted yet for this study

Summary

After the use of second-generation ALK-TKI drug resistance, about 50% of tissue biopsies showed mutations in the ALK kinase domain, and appropriate ALK-TKI could be selected according to different mutation sites .Phase I/II clinical trials in the US of ensatinib showed ORR of 25% (4/16) in patients previously treated with crizotinib and second-generation ALK-TKI (N=16) .In the phase II registered clinical study in China, biomarker analysis also showed that the ORR of ensatinib against drug resistance site G1202R was 33% (2/6).The ORR of I1171 and F1174 were 50% (2/4) and 71% (5/7), respectively, suggesting that ensatinib may still be effective in patients with drug resistance to other second-generation ALK inhibitors . Investigators designed this study to evaluate the clinical efficacy of ensatinib after second-generation ALK-TKI resistance.The study was a single-arm, multi-center Phase II clinical study, using ORR of patients with measurable lesions as the primary endpoint, and using Simon two-stage design to estimate the required sample size.At a 5% level of significance and 85% confidence, a minimum of 40 evaluable subjects were required for both phases.In the first stage, 20 patients were enrolled. If 2 patients had objective response, an additional 20 patients were enrolled in the second stage. If more than 5 patients /40 patients had objective response, the therapeutic drugs were considered effective.Eligible patients will take 225mg of ensaritinib orally once daily, on an empty stomach or with food, until the patient develops disease progression, develops unacceptable toxicity, the investigator or subject decides to drop out, loses follow-up, starts another antitumor therapy, or dies.The primary end points were objective response rate (ORR) to disease progression, occurrence of unacceptable toxicity, investigator or subject decision to drop out, loss of follow-up, initiation of other antitumor therapy, or death.

Conditions

  • The Diagnosis Was ALK Positive NSCLC
  • Second Generation ALK-TKI is Resistant
  • Efficacy of Ensatinib in This Subset of Patients

Interventions

DRUG

Ensartinib

Ensaritinib was taken orally once 225mg, on an empty stomach or with food, until the patient developed disease progression, developed unacceptable toxicity, the investigator or subject decided to drop out, lost follow-up, initiated other antitumor therapy, or died

Sponsors & Collaborators

  • Li Zhang, MD

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2023-07-01
Completion
2024-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05178511 on ClinicalTrials.gov