Clinical trial NCT06010329: A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Oncology
Sutetinib Maleate Capsule
Teligene
Cancer
Lead sponsor: Teligene US
Sponsor class: INDUSTRY
First posted: 2023-08-24
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Eligibility 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.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Pre-dose up to approximately 32 months post-dose
Secondary outcomes:
measure: Duration of Response (DoR)
timeFrame: Pre-dose up to approximately 32 months post-dose
measure: Disease Control Rate (DCR)
timeFrame: Pre-dose up to approximately 32 months post-dose
measure: Progression Free Survival (PFS)
timeFrame: Pre-dose up to approximately 32 months post-dose
measure: Time to Tumor Progression (TTP)
timeFrame: Pre-dose up to approximately 32 months post-dose
measure: Time to Response (TTR)
timeFrame: Pre-dose up to approximately 32 months post-dose
measure: Time to Treatment Failure (TTF)
timeFrame: Pre-dose up to approximately 32 months post-dose
measure: Overall Survival (OS)
timeFrame: Pre-dose up to approximately 32 months post-dose
measure: 1-year Progression Free Survival
timeFrame: Pre-dose up to 1 year post-dose
measure: 1-year Survival
timeFrame: Pre-dose up to 1 year post-dose
measure: Area Under The Curve (AUC) of Sutetinib Maleate Capsule
timeFrame: Pre-dose up to 24 hours post-dose
measure: Maximum Plasma Concentration (Cmax) of Sutetinib Maleate Capsule
timeFrame: Pre-dose up to 24 hours post-dose
measure: Minimum Plasma Concentration (Cmin) of Sutetinib Maleate Capsule
timeFrame: Pre-dose up to 24 hours post-dose
measure: Time to Peak Drug Concentration (Tmax) of Sutetinib Maleate Capsule
timeFrame: Pre-dose up to 24 hours post-dose
measure: Sutetinib Maleate Capsule half-life (T1/2)
timeFrame: Pre-dose up to 24 hours post-dose
measure: Apparent Clearance (CL/f) of Sutetinib Maleate Capsule
timeFrame: Pre-dose up to 24 hours post-dose
measure: Volume of Distribution (Vz/F) of Sutetinib Maleate Capsule
timeFrame: Pre-dose up to 24 hours post-dose
measure: Number of Participants Experiencing Adverse Events (AE)
timeFrame: Pre-dose up to approximately 32 months post-dose
measure: Number of Participants Experiencing Adverse Drug Reactions (ADR)
timeFrame: Pre-dose up to approximately 32 months post-dose
measure: Number of Participants Experiencing Serious Adverse Events (SAE)
timeFrame: Pre-dose up to approximately 32 months post-dose
measure: Number of Participants Experiencing Srious Adverse Reactions (SAR)
timeFrame: Pre-dose up to approximately 32 months post-dose
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Oncology Physicians Network Healthcare
state: California
city: La Jolla
country: United States
facility: University of California San Diego Moores Cancer Center
state: California
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Athens
country: United States
facility: University Cancer & Blood Center (UCBC) - Athens
state: Georgia
city: Des Moines
country: United States
facility: Mission Cancer + Blood - Mission Cancer Foundation
state: Iowa
city: Louisville
country: United States
facility: Norton Cancer Institute - Downtown
state: Kentucky
city: New Hyde Park
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Perlmutter Cancer Center - 34th Street
state: New York
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
References: