A Real World Study of Ensartinib in Advanced ALK-positive NSCLC

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05498064
Collaborator
Betta Pharmaceuticals Co., Ltd. (Industry)
490
1
78.7
6.2

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the efficacy and safety of Ensartinib in advanced ALK-positive non-small cell lung cancer, and the mechanisms of population pharmacokinetics and resistance to Ensartinib.

Detailed Description

Participants will receive Ensartinib at 225 mg orally once a day (QD). Treatments will continue until disease progression, meeting one of treatment discontinuation criteria (eg, patient decision, adverse event, pregnancy). At the time of disease progression, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier. Collection of venous blood sample from participants included 3 times: before treatment, 8 weeks of treatment, and disease progression. Blood specimens of 8 ml were collected each time for ctDNA NGS testing, and evaluation of Ensartinib population pharmacokinetics with blood sampling after 8 weeks.

Study Design

Study Type:
Observational
Anticipated Enrollment :
490 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Real World Study of Ensartinib in Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)
Actual Study Start Date :
May 13, 2022
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 1, 2028

Outcome Measures

Primary Outcome Measures

  1. Progression free survival (PFS) [36 months]

    Defined as time from first dose of Ensartinib to disease progression or death due to any causes

Secondary Outcome Measures

  1. The objective response rate (ORR) [36 months]

    ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR).

  2. Overall survival (OS) [48 months]

    OS, defined as time from first dose of Ensartinib to death due to any cause

  3. 12 month/24 month/36 month/48 month-overall survival (OS) rate OS [12 months,24 months,36 months,48 months]

    Defined as the time from randomization to death from any cause. The OS rate was estimated based on the landmark analysis.

  4. Incidence of patients experiencing adverse events (AE) [36 months]

    Adverse events are graded according to CTCAE 5.0

Other Outcome Measures

  1. Peak plasma concentration (Cmax) of Ensartinib. [Three hours after Ensartinib treatment]

    Evaluation of Ensartinib population Cmax pharmacokinetics.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Histologically or cytologically confirmed stage III b or IV NSCLC, according to the International Association for the Study of Lung Cancer staging manual in Thoracic Oncology, 8th edition.

  2. Documented ALK-positive disease according to FISH , Ventana IHC ,RT-PCR or NGS;

  3. Patients must have demonstrated progression during or after ALK-TKI treatment;

  4. Eastern cooperative oncology group performance status (ECOG PS) of 0-2, overall survival>3 months;

  5. Patients need radiotherapy or can receive radiotherapy, such as bone metastatic lesions, intrapulmonary lesions, adrenal lesions, etc.

  6. Initially general blood tests including complete blood count, biochemistry, electrolytes, and urine biochemistry were performed as a routine screening in order to identify any abnormalities.

  7. Male and female patients must agree to abstain or to use two highly effective forms of contraception during the treatment period and for 90 days after the last dose of study medication.

Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital Beijing Beijing China 100730

Sponsors and Collaborators

  • Peking Union Medical College Hospital
  • Betta Pharmaceuticals Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wang mengzhao, Chief Director of Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT05498064
Other Study ID Numbers:
  • BD-EN-IV007
First Posted:
Aug 11, 2022
Last Update Posted:
Aug 11, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wang mengzhao, Chief Director of Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2022