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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-dose up to 1 year post-dose

Awards & highlights

Study Summary

This trial will study a new drug to treat lung cancer in people with uncommon EGFR mutations.

Who is the study for?

Adults with advanced or metastatic non-small cell lung cancer (NSCLC) that have uncommon EGFR mutations can join. They should have at least one measurable tumor, good organ function, an ECOG score of 0-2, and a life expectancy over 3 months. People who've had certain treatments recently or have active infections, brain metastases, trouble swallowing pills, or use drugs affecting CYP3A4 can't participate.Check my eligibility

What is being tested?

The trial is testing Sutetinib Maleate Capsules to see how effective they are for NSCLC patients with specific genetic changes in their tumors. It's focused on those who haven't used certain other cancer drugs before.See study design

What are the potential side effects?

Possible side effects include typical reactions to cancer medications such as nausea, fatigue, liver issues (like elevated enzymes), skin rash and diarrhea. There may also be unique side effects related to this drug not listed here.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose up to 1 year post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose up to 1 year post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose up to 1 year post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR)

Secondary outcome measures

1-year Progression Free Survival

1-year Survival

Apparent Clearance (CL/f) of Sutetinib Maleate Capsule

+17 more

Side effects data

From 2017 Phase 4 trial • 401 Patients • NCT02202616

Upper respiratory tract infection

Chronic obstructive pulmonary disease

Cough

Bronchitis

Dyspnoea

Dyspepsia

Pneumonia

Nausea

Dizziness

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

QVA149 110/50

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single arm, Open labelExperimental Treatment1 Intervention

Participants will receive sutetinib maleate capsule taken orally with (preferred) or without food, at the dose directed by the Investigators, 28 days for a cycle.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Teligene USLead Sponsor

2 Previous Clinical Trials

159 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the Single arm, Open label treatment method sanctioned by the FDA?

"Since this is a phase 2 trial, there are safety data available but efficacy information remains unknown. Thus, Single arm, Open label was assigned a score of 2 on the rating scale."

Answered by AI

Is enrollment in this clinical research still an option for potential subjects?

"Affirmative. According to the clinicaltrials.gov repository, this medical investigation is actively seeking enrollees and was initially shared on October 1st 2023. The post has been updated as of October 17th 2023 and requires 66 participants at a single site."

Answered by AI

What is the capacity of this research initiative?

"Affirmative. The information on clinicaltrials.gov declares that this trial, which was initially posted on October 1st 2023 is actively recruiting participants. Sixty-six individuals need to be sought from one medical site for the study's success."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC

2023. "A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06010329.