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Study to Evaluate Sutetinib Maleate Capsule in Locally Advanced or Metastatic Non-small Cell Lung Cancer
NCT05168566 · View on ClinicalTrials.gov ↗
Study 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)
Conditions Studied
Interventions
- DRUG Sutetinib Maleate Capsule
Study Locations (20)
Beijing Municipality
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing
- Beijing Cancer Hospital — Beijing
- Peking Union Medical College Hospital — Beijing
- Beijing Chest Hospital — Beijing
Henan
- Henan Cancer Hospital — Zhengzhou
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou
California
- OPN Healthcare, Inc. — Glendale
Georgia
- University Cancer & Blood Center — Athens
Kentucky
- Baptist Health — Louisville
Maryland
- University of Maryland Medical Center — Baltimore
North Carolina
- FirstHealth Cancer Center — Pinehurst
Texas
- The University of Texas- MD Anderson Cancer Center — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2022-09-01 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05168566
The ClinicalTrials.gov registry entry for NCT05168566 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 99 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teligene US, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Non-small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention — of which Sutetinib Maleate Capsule is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05168566 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Beijing Municipality, Henan, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05168566 about?
NCT05168566 is a clinical study titled "Study to Evaluate Sutetinib Maleate Capsule in Locally Advanced or Metastatic Non-small Cell Lung Cancer". 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)
What is the current status of trial NCT05168566?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 99 participants. The study started on 2022-09-01. Estimated completion is 2026-06.
What conditions does trial NCT05168566 study?
This clinical trial studies the following conditions: Non-small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05168566?
The interventions under investigation include: Sutetinib Maleate Capsule (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05168566?
This trial is sponsored by Teligene US, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05168566 being conducted?
This trial has 20 study locations across California, Georgia, Kentucky, Maryland, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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