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

Part of paid clinical trials in Glendale, California.

Sponsor
Teligene US
Study ID
NCT05168566
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Sutetinib Maleate Capsule — DRUG
    Study drug to be taken orally with or without food (with food preferred) for up to13 cycles

Study Details

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)

Key Dates

Start date
Sep 1, 2022
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

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

Arms

  • Experimental: Sutetinib Maleate Arm
    Sutetinib capsules monotherapy

Primary Outcome Measure

Assessment of Objective response rate (ORR) [ Time Frame: 2 Years ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
OPN Healthcare, Inc.GlendaleCalifornia91203
Heather Lyon
[email protected]
818-254-2526
Anthony Lam, MD, MHS (PRINCIPAL_INVESTIGATOR)
University Cancer & Blood CenterAthensGeorgia30607
Petros Nikolinakos, MD
Baptist HealthLouisvilleKentucky40223-
University of Maryland Medical CenterBaltimoreMaryland21201
Samuel Rosner, M.D.
[email protected]
410-328-6373
FirstHealth Cancer CenterPinehurstNorth Carolina28374
Charles Kuzma, MD
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Glendale, CA

By condition
Lung cancer
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OncologyLung oncologyLung disease
By research site
OPN Healthcare, Inc.· Glendale, CAUniversity Cancer & Blood Center· Athens, GABaptist Health· Louisville, KYUniversity of Maryland Medical Center· Baltimore, MDFirstHealth Cancer Center· Pinehurst, NCUniversity of Texas MD Anderson Cancer Center· Houston, TX

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