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NCT Number: NCT07199010

Real-world Study of Taletrectinib in Advanced ROS1+ NSCLC Following Entrectinib Progression

This is a multicenter, non-interventional, observational real-world study to evaluate the efficacy and safety of Taletrectinib in ROS1-positive non-small cell lung cancer (NSCLC) following Entrectinib progression. Patients deemed eligible for Taletrectinib by their physicians were enrolled after providing informed consent. Taletrectinib will be administered according to clinical practice and data on treatment patterns, clinical outcomes, and safety will be collected during routine evaluations.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai East Hospital (The East Hospital Affiliated to Tongji University)

Shanghai, Shanghai Municipality, 200120, China

Location contact

Joshua GUO

CONTACT

[email protected]

+86-18819430923

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years.
  • Histologically or cytologically metastatic NSCLC (UICC/AJCC TNM Staging System, 9th Edition, Stage Ⅳ).
  • At least one measurable target tumor lesion as accessed by RECIST v1.1 criteria.
  • Documented ROS1 gene fusion identified by an approved molecular testing method (FISH, RT-PCR, or NGS).
  • Progressed following entrectinib treatment, regardless of prior exposure to chemotherapy, antiangiogenic multikinase inhibitors, or immunotherapy.
  • Considered by the investigator to be candidates for Taletrectinib treatment ; OR Patients with ≤6 months of prior Taletrectinib exposure enrolled retrospectively. (Note: For retrospective patients deceased before enrollment, waiver of informed consent is required. Patients who initiated and discontinued treatment within 6 months prior to signing informed consent are eligible).
  • Signed Informed Consent.

Exclusion criteria

  • Patients with driver gene mutations/alterations that have approved targeted therapies , including but not limited to EGFR, ALK, RET, etc.
  • Currently participating in other interventional clinical trials or having received investigational drug treatment within 4 weeks prior to enrollment .
  • Pregnancy or breastfeeding.
  • Patients with uncontrolled co-morbidities who are assessed by the investigator not to receive targeted therapy.
  • Other conditions that are assessed by the investigator to be unsuitable for enrollment in this study.

Treatment and study plan

Taletrectinib

Drug

Taletrectinib, 600mg, QD

Other names: AB-106, DS-6051b

Primary outcomes

  1. ORR

    Time frame: 6 months

    Objective response rate

Secondary outcomes

  1. PFS

    Time frame: 25 months

    Description: Progression free survival

  2. DoR

    Time frame: 25 months

    Duration of response

  3. DCR

    Time frame: 6 months

    Disease control rate

  4. OS

    Time frame: 51 months

    Overall survival

  5. iORR

    Time frame: 6 months

    Intracranial objective response rate

  6. iPFS

    Time frame: 25 months

    Intracranial progress free survival

  7. iDoR

    Time frame: 6 months

    Intracranial duration of response

  8. iDCR

    Time frame: 6 months

    Intracranial disease control rate

  9. Adverse events

    Time frame: 25 months

    Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities, graded by the NCI CTCAE 5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Joshua GUO

CONTACT

[email protected]

+86-18819430923

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Multicenter, Non-interventional, Observational Study of Taletrectinib in Advanced ROS1+ NSCLC Following Entrectinib Progression

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 30, 2025
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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