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NCT05168566 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate Sutetinib Maleate Capsule in Locally Advanced or Metastatic Non-small Cell Lung Cancer
A Phase 2 study of Non-Small Cell Lung Cancer, sponsored by Teligene US.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 99
- Enrollment target
- 20
- Study locations
NCT05168566: Recruiting Phase 2 study of Non-Small Cell Lung Cancer, sponsored by Teligene US.
NCT05168566 is a Phase 2 study of Non-Small Cell Lung Cancer that is actively recruiting participants, run by Teligene US. The registered enrollment target is 99 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05168566, a Phase 2 study of Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by Teligene US.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 99 participants
- Enrollment target
- 20
- Study locations
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)
Primary Outcome
Objective response rate (ORR) assessed by IRC
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 |
What NCT05168566 shows while recruiting
NCT05168566 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (85% lower).
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.
NCT05168566 names 20 study sites across 16 states, led by Beijing Municipality, Henan, California.
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.
What interventions are being tested in trial NCT05168566?
The interventions under investigation include: Sutetinib Maleate Capsule (DRUG).
Who is sponsoring clinical trial NCT05168566?
This trial is sponsored by Teligene US, which has 3 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Non-Small Cell Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05168566's enrollment target sits among peer trials
99 244th of 454 higher than 210 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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