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NCT06010329

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

StatusRecruiting
PhasePhase 2
Primary completion (estimated)
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Record History

All 12 versions: 12 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 15 words
    • Trial sites expanded: 9 → 24 locations
    • Secondary endpoints: details revised at 3 of 20 entries
  2. Primary completion date: Apr 2026 to Dec 2027
    • Study completion date: Apr 2026 to Dec 2028
    v11
  3. Primary and study completion dates: Sep 2025 to Apr 2026
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 11 of 20 entries
    v10
  4. Site details revised at 2 of 9 sitesv9
  5. Study sites: 6 to 9v8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 5 to 6v7
  2. Study sites: 4 to 5v6
  3. Eligibility criteria shortened, about 2 words
    • Primary and study completion dates: Jun 2025 to Sep 2025
    • Study description shortened, about 1 word
    v5
  4. Study sites: 1 to 4
    • Start date changed from estimate of Dec 2023 to Dec 27, 2023
    v4
  5. Start date: Oct 2023 to Dec 2023
    • Primary and study completion dates: May 25, 2025 to Jun 2025
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date: Sep 29, 2023 to Oct 2023
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Objective Response Rate (ORR)
Timeframe: Pre-dose up to approximately 32 months post-dose

Secondary (20)

Duration of Response (DoR)
Disease Control Rate (DCR)
Progression Free Survival (PFS)
Time to Tumor Progression (TTP)
Time to Response (TTR)
Show 15 moreShow less
Time to Treatment Failure (TTF)
Overall Survival (OS)
1-year Progression Free Survival
1-year Survival
Area Under The Curve (AUC) of Sutetinib Maleate Capsule
Maximum Plasma Concentration (Cmax) of Sutetinib Maleate Capsule
Minimum Plasma Concentration (Cmin) of Sutetinib Maleate Capsule
Time to Peak Drug Concentration (Tmax) of Sutetinib Maleate Capsule
Sutetinib Maleate Capsule half-life (T1/2)
Apparent Clearance (CL/f) of Sutetinib Maleate Capsule
Volume of Distribution (Vz/F) of Sutetinib Maleate Capsule
Number of Participants Experiencing Adverse Events (AE)
Number of Participants Experiencing Adverse Drug Reactions (ADR)
Number of Participants Experiencing Serious Adverse Events (SAE)
Number of Participants Experiencing Srious Adverse Reactions (SAR)

Arms and interventions

Single arm, Open labelExperimental

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.

Drugs: Sutetinib Maleate Capsule

Sites

24 sites in 2 countries

China 14, United States 10