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

Part of paid clinical trials in Glendale, California.

Sponsor
Teligene US
Study ID
NCT06010329
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sutetinib Maleate Capsule — DRUG
    Oral administration

Study Details

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).

Key Dates

Start date
Dec 27, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
66 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single arm, Open label
    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.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Pre-dose up to approximately 32 months post-dose ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Oncology Physicians Network HealthcareGlendaleCalifornia91203-
University of California San Diego Moores Cancer CenterLa JollaCalifornia92093-
Moffitt Cancer CenterTampaFlorida33612-
University Cancer & Blood Center (UCBC) - AthensAthensGeorgia30607-
Mission Cancer + Blood - Mission Cancer FoundationDes MoinesIowa50309-
Norton Cancer Institute - DowntownLouisvilleKentucky40202-
Northwell HealthNew Hyde ParkNew York11042-
Perlmutter Cancer Center - 34th StreetNew YorkNew York10016-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Glendale, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Oncology Physicians Network Healthcare· Glendale, CAUniversity of California San Diego Moores Cancer Center· La Jolla, CAMoffitt Cancer Center· Tampa, FLUniversity Cancer & Blood Center (UCBC) - Athens· Athens, GAMission Cancer + Blood - Mission Cancer Foundation· Des Moines, IANorton Cancer Institute - Downtown· Louisville, KY

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