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Tyrosine Kinase Inhibitor

Sutetinib for Non-Small Cell Lung Cancer

Phase 2
Recruiting
Research Sponsored by Teligene US
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmation that the tumor harbors a non-resistant uncommon EGFR mutation (tumor tissue biopsy), including one or more of L861Q, G719X and S768I mutations, excluding any other EGFR sensitive mutations and/or oncogenes
ECOG score of 0, 1, or 2
Must not have
Females who are pregnant or breastfeeding
Inability to swallow the study medication, any seriously chronic gastrointestinal disorder, malabsorption syndrome or any other conditions with influence on gastrointestinal absorption
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer drug for people with non-resistant EGFR mutations. The study will evaluate the safety and effectiveness of the drug.

Who is the study for?
Adults with a specific type of advanced lung cancer (NSCLC) that has certain uncommon EGFR mutations. They should have good organ function, an ECOG score of 0-2, and at least one measurable lesion. Participants must not have had extensive prior treatments or serious health issues like active brain metastases or heart disease.
What is being tested?
The trial is testing Sutetinib Maleate Capsule's safety and effectiveness in treating NSCLC with specific EGFR mutations. It's an open-label Phase 2b study, meaning both researchers and participants know what treatment is being given.
What are the potential side effects?
While the exact side effects are not listed here, similar medications often cause diarrhea, skin reactions, fatigue, mouth sores, loss of appetite and potential liver enzyme changes. Close monitoring will be done to manage any adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor has a specific rare EGFR mutation but no other sensitive mutations.
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I can take care of myself and am up and about more than half of my waking hours.
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My lung cancer is advanced or has spread, and I've had 1 or fewer chemotherapy treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or breastfeeding.
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I cannot swallow pills or have a chronic stomach problem affecting food absorption.
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I have no lasting side effects from previous treatments, except for hair loss.
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I have a serious heart condition.
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I have lung issues like scarring or inflammation not caused by an infection, and fluid around my heart or lungs.
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My cancer has spread to my brain.
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I do not have any uncontrolled infections.
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I have used EGFR-TKI medication for cancer treatment before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assessment of Objective response rate (ORR)
Secondary study objectives
Assess incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Sutetinib Maleate ArmExperimental Treatment1 Intervention
Sutetinib capsules monotherapy

Find a Location

Who is running the clinical trial?

Teligene USLead Sponsor
2 Previous Clinical Trials
126 Total Patients Enrolled

Media Library

Sutetinib Maleate Capsule (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05168566 — Phase 2
Lung Cancer Research Study Groups: Sutetinib Maleate Arm
Lung Cancer Clinical Trial 2023: Sutetinib Maleate Capsule Highlights & Side Effects. Trial Name: NCT05168566 — Phase 2
Sutetinib Maleate Capsule (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05168566 — Phase 2
~31 spots leftby Nov 2025
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