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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My tumor has a specific rare EGFR mutation but no other sensitive mutations.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of Objective response rate (ORR)
Secondary outcome measures
Assess incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Assessment of 1-year progression-free survival
Assessment of 1-year survival
+8 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a known problem with alcohol or drugs.I am not pregnant or breastfeeding.I cannot swallow pills or have a chronic stomach problem affecting food absorption.You have a mental illness or have trouble following instructions.I have no lasting side effects from previous treatments, except for hair loss.I am 18 years old or older.My blood, liver, kidney, and clotting tests are within normal ranges.I have a serious heart condition.My tumor has a specific rare EGFR mutation but no other sensitive mutations.I haven't taken drugs or foods that strongly affect the enzyme CYP3A4 in the last 14 days or more.I have lung issues like scarring or inflammation not caused by an infection, and fluid around my heart or lungs.You have had an organ or stem cell transplant in the past.I haven't had cancer treatments or used traditional Chinese medicines for tumors in the last 4 weeks.My cancer has spread to my brain.I haven't had any other major cancers in the last 3 years.I have not had major surgery or a serious injury in the last 4 weeks.I do not have any uncontrolled infections.I can take care of myself and am up and about more than half of my waking hours.You have at least one specific area of the body that can be measured to see changes during the study.You are expected to live for at least 3 more months.I have used EGFR-TKI medication for cancer treatment before.My lung cancer is advanced or has spread, and I've had 1 or fewer chemotherapy treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Sutetinib Maleate Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open enrollment opportunities for this trial at present?
"As indicated on the clinicaltrials.gov platform, this study is not presently enrolling patients. Initially posted in June of 2022 and last updated a few weeks later, it has since closed its recruitment period; however, 1949 other trials are currently looking for participants."
Answered by AI
Is Sutetinib Maleate Capsule a secure remedy for patients?
"Our assessment of sutetinib maleate capsule's safety merits a score of 2. This is due to the drug being in Phase 2 with evidence suggesting safety, but no proof yet that it provides an effective treatment."
Answered by AI
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