Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06010329 | RECRUITING | Non-small Cell Lung Cancer

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

Read the US carefully

Brief 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).

Condition or disease

Non-small Cell Lung Cancer

Intervention/treatment

Sutetinib Maleate Capsule

Phase

PHASE2

Detailed Description:

Sutetinib is an investigational irreversible EGFR tyrosine kinase inhibitor. EGFR is a gene that makes a protein that is involved in cell growth and cell survival. Mutated (changed) forms of the EGFR gene and protein have been found in some types of cancer, including non-small cell lung cancer. These changes may cause cancer cells to grow and spread in the body. The purpose of this study is to explore how effective sutetinib maleate capsules are for the treatment of patients with locally advanced or metastatic NSCLC with uncommon EGFR mutations.

Study Type : INTERVENTIONAL
Estimated Enrollment : 66 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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)
Actual Study Start Date : 2023-12-27
Estimated Primary Completion Date : 2026-04
Estimated Study Completion Date : 2026-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Age 18 years old and above, male or female
  • 2. Histopathological and/or cytopathological confirmation of locally advanced or metastatic NSCLC
  • 3. Confirmation that the tumor harbors an uncommon epidermal growth factor receptor (EGFR) mutation (tumor tissue biopsy)
  • 4. At least one measurable lesion
  • 5. Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2
  • 6. A minimum life expectancy of \> 3 months
  • 7. Adequate bone marrow reserve, hepatic, renal, and coagulation function
  • Other inclusion criteria apply for participating in the study.
Exclusion Criteria
  • 1. Participant ever used the epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR TKI) for anti-tumor therapy prior to enrollment (Cohort 1), or second generation EGFR TKI (Cohort 2)
  • 2. Any systemic anti-tumor therapy such as chemotherapy and radiation therapy (including curative radiotherapy or spinal radiotherapy portion \>30%) used within 3 weeks prior to enrollment; immunotherapy within 4 weeks; any palliative radiotherapy for non-target lesions used to relieve symptoms and traditional Chinese medicines indicated for the tumor within 2 weeks prior to enrollment; Cohort 2: any EGFR TKIs within 5 half-lives.
  • 3. Use or intake of drugs or foods containing potent inhibitors or inducers of cytochrome P450 isozyme 3A4 (CYP3A4) within 14 days or 5 half-lives, whichever is the longer, prior to enrollment
  • 4. Surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment
  • 5. Any unresolved toxicities from prior therapy greater than National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAEv5.0) Grade 1, at the time of screening except for alopecia
  • 6. Inability to swallow the study medication, any seriously (NCI-CTCAEv5.0 ≥ Grade 3) chronic gastrointestinal disorder, malabsorption syndrome or any other conditions with influence on gastrointestinal absorption
  • 7. Active central nervous system metastases
  • 8. Any active infection which has not been controlled at screening
  • Other exclusion criteria apply for participating in the Study.
A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC

Location Details

NCT06010329

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

WITHDRAWN

United States, California

Oncology Physicians Network Healthcare

Glendale, California, United States, 91203

RECRUITING

United States, California

University of California San Diego Moores Cancer Center

La Jolla, California, United States, 92093

RECRUITING

United States, Florida

Moffitt Cancer Center

Tampa, florida, United States, 33612

RECRUITING

United States, Georgia

University Cancer & Blood Center (UCBC) - Athens

Athens, Georgia, United States, 30607

RECRUITING

United States, Iowa

Mission Cancer + Blood - Mission Cancer Foundation

Des Moines, Iowa, United States, 50309

WITHDRAWN

United States, Kentucky

Norton Cancer Institute - Downtown

Louisville, Kentucky, United States, 40202

ACTIVE NOT RECRUITING

United States, New York

Northwell Health

New Hyde Park, New York, United States, 11042

RECRUITING

United States, New York

Perlmutter Cancer Center - 34th Street

New York, New York, United States, 10016

RECRUITING

United States, Texas

University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030