Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06762327

Ensartinib in the Treatment of ALK Positive or MET Exon 14 Skipping Anvanced Solid Tumors Excluded Lung Cancer

In lung cancer, ensartinib is effective in improving the prognosis of ALK positive /MET exon 14 skipping patients. However, patients with ALK positive /MET14 exon skipping non-lung cancer solid tumors have limited treatment options in the absence of standard treatment. We hope to bring a new effective and safe treatment option to these patients more efficiently.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Advanced/metastatic solid tumors other than primary lung cancer
  • Alk-positive or MET14 exon skipping mutation by IHC\\FISH\\NGS\\RT-PCR
  • Have no standard treatment after MDT discussion, or could not tolerate the standard treatment, or the patient refused the standard treatment
  • Adequate liver and kidney function
  • Adequate bone marrow function
  • ECOG PS 0-3
  • Female subjects should not be pregnant. All human subjects should able to comply with the required protocol and follow-up procedures, and able to receive oral medications Written informed consent provided

Exclusion criteria

  • Active viral, bacterial, or fungal infection detected 2 weeks before enrollment
  • Pregnancy or lactation
  • receiving medications or herbal supplements with potent inducers of CYP3A4 (at least 3 weeks prior)
  • Any severe or uncontrolled systemic illness, including uncontrolled Hypertension and active bleeding, any nonadherence that the investigator considered to be detrimental to study participation or adherence to the protocol, or active infections including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV)
  • Ineligible cardiac function
  • Interstitial lung disease, drug-induced interstitial lung disease, previous history of radiation pneumonitis requiring steroid therapy, or any evidence of active interstitial lung disease
  • Lack of adequate bone marrow reserve or organ function

Treatment and study plan

Ensartinib

Drug

ensartinib 225mg ,PO,QD,until disease progression or intolerable toxicity

Primary outcomes

  1. progression-free survival

    Time frame: 2 years

    time to progression or Intolerable toxicity occurred

  2. Overall responce rate

    Time frame: 1year

    Proportion of patients with CR/PR response in the total population

Secondary outcomes

  1. Disease control rate

    Time frame: 1year

    Proportion of patients with CR/PR/SD response in the total population

  2. Overall survival

    Time frame: 3 years

    time to death

  3. Duration of responce

    Time frame: 3 years

    time from first assessment of CR or PR to the first assessment of PD or death

  4. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Time frame: 3 years

    The safety of Ensartinib treatment will be assessed according to CTCAE v5.0 criteria observed over the whole treatment period.

Study contacts

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

Xiaowei Wei

CONTACT

[email protected]

025-52271000

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 7, 2025
Registry last updated
Jan 7, 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.

Published trials that share one or more normalized conditions with this study.