RecruitingPhase 2NCT05168566

Study to Evaluate Sutetinib Maleate Capsule in Locally Advanced or Metastatic Non-small Cell Lung Cancer

A Multicenter, Open-label, Phase IIb Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Non-resistant Uncommon EGFR Mutations Only, Including L861Q, G719X, and/or S768I)

Sponsor

Teligene US

Enrollment

99 participants

Start Date

Sep 1, 2022

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

Summary

This is a Phase 2b, multicenter, open-label study to evaluate the safety and efficacy of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Non-resistant Uncommon EGFR Mutations Only, Including L861Q, G719X, and/or S768I)

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing sutetinib maleate, an oral targeted therapy, in people with advanced or metastatic non-small cell lung cancer (NSCLC) that has certain uncommon mutations in the EGFR gene — specifically L861Q, G719X, or S768I mutations. **You may be eligible if...** - You are 18 years of age or older - You have advanced or metastatic NSCLC confirmed by biopsy - Your tumor has one of the uncommon EGFR mutations (L861Q, G719X, or S768I) and no other sensitive EGFR mutations - You have received at most one prior line of chemotherapy - You have a measurable tumor lesion - You are in reasonably good health (ECOG 0–2) with at least 3 months life expectancy **You may NOT be eligible if...** - You have previously taken an EGFR-targeted drug (EGFR-TKI) for this cancer - You have had systemic anti-cancer treatment or radiation in the past 4 weeks - You have had major surgery in the past 4 weeks - You are pregnant or breastfeeding 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

Study drug to be taken orally with or without food (with food preferred) for up to13 cycles

Locations(26)

OPN Healthcare, Inc.

Glendale, California, United States

University Cancer & Blood Center

Athens, Georgia, United States

Baptist Health

Louisville, Kentucky, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

FirstHealth Cancer Center

Pinehurst, North Carolina, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Beijing Chest Hospital

Beijing, Beijing Municipality, China

The Affiliated Cancer Hospital of Chongqin University

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Wuhan Union Hospital of China

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Jilin Cancer Hospital

Changchun, Jilin, China

The First Affiliated Hospital of China Medical University

Shengyang, Liaoning, China

Linyi Cancer Hospital

Linyi, Shangdong, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT05168566

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