Who is sponsoring NCT05168566?

NCT05168566 is sponsored by Teligene US.

What condition does NCT05168566 study?

NCT05168566 studies Non-small Cell Lung Cancer.

What drugs are being tested in NCT05168566?

Interventions: Sutetinib Maleate Capsule.

What is the status of NCT05168566?

NCT05168566 is currently RECRUITING.

Last reviewed 2026-04-22 · How we verify

A Multicenter, Open-label, Phase IIb Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Non-resistant Uncommon EGFR Mutations Only, Including L861Q, G719X, and/or S768I)

NCT05168566 Phase 2 RECRUITING

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)

Details

Lead sponsor	Teligene US
Phase	Phase 2
Status	RECRUITING
Enrolment	99
Start date	2022-09-01
Completion	2028-12

Conditions

Non-small Cell Lung Cancer

Interventions

Sutetinib Maleate Capsule

Primary outcomes

Assessment of Objective response rate (ORR) — 2 Years
Objective response rate (ORR) assessed by IRC

Countries

United States, China