RecruitingPhase 2NCT06010329

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

A Multicenter, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Uncommon EGFR Mutations Only)


Sponsor

Teligene US

Enrollment

66 participants

Start Date

Dec 27, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The main objective of the study will be to evaluate the efficacy of sutetinib maleate capsules in participants with locally advanced or metastatic non-small cell lung cancer NSCLC (uncommon EGFR mutations only).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a drug called sutetinib maleate capsule for people with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has an uncommon EGFR gene mutation. EGFR mutations tell cancer cells to grow rapidly, and targeted drugs like sutetinib aim to block this signal. **You may be eligible if...** - You are 18 or older - You have confirmed locally advanced or metastatic NSCLC with an uncommon EGFR mutation - You have never received an EGFR-targeting drug (Cohort 1) or have not received a second-generation EGFR drug (Cohort 2) - You are in good health (ECOG 0–2) - You have at least one measurable tumor and a life expectancy over 3 months - Your blood, liver, kidney, and clotting function are adequate **You may NOT be eligible if...** - You received chemotherapy, radiation, or immunotherapy within the past 3–4 weeks - You are currently taking medications that strongly affect a liver enzyme called CYP3A4 - You had major surgery in the past 3 weeks and haven't fully recovered - You are pregnant, breastfeeding, or not using adequate contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSutetinib Maleate Capsule

Oral administration


Locations(9)

Oncology Physicians Network Healthcare

Glendale, California, United States

University of California San Diego Moores Cancer Center

La Jolla, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

University Cancer & Blood Center (UCBC) - Athens

Athens, Georgia, United States

Mission Cancer + Blood - Mission Cancer Foundation

Des Moines, Iowa, United States

Norton Cancer Institute - Downtown

Louisville, Kentucky, United States

Northwell Health

New Hyde Park, New York, United States

Perlmutter Cancer Center - 34th Street

New York, New York, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06010329


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