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Chemotherapy or Chemotherapy Plus PD-1 Antibody in RET Fusion Positive Advanced NSCLC Patitnts: the POSEIDON Trial (POSEIDON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04322591
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
Yongchang Zhang, Hunan Province Tumor Hospital

Study Description
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Brief Summary:
This study aims to explore the efficacy and safety of chemotherapy or chemotherapy plus PD-1 antibody in RET Fusion Positive Advanced Non-small Cell Lung Cancer.

Condition or disease
Non-small Cell Lung Cancer

Detailed Description:
This study aims to explore the efficacy and safety of chemotherapy or chemotherapy plus the PD-1 antibody in RET Fusion Positive Advanced Non-small Cell Lung Cancer. We aim to enrolled 100 patients in this study, the primary endpoint was PFS.
Study Design
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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Chemotherapy or Chemotherapy Plus PD-1 Antibody in RET Fusion Positive Advanced Non-small Cell Lung Cancer ( Poseidon Study）
Actual Study Start Date : March 24, 2020
Estimated Primary Completion Date : December 24, 2022
Estimated Study Completion Date : March 24, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. PFS [ Time Frame: may 2020- may 2021 (1 year) ]
    Progression free survival time


Secondary Outcome Measures :
  1. ORR [ Time Frame: may 2020- may 2021 (1 year) ]
    Overal response rate

  2. OS [ Time Frame: may 2020- may 2021 (1 year) ]
    Overall survival time


Biospecimen Retention:   Samples With DNA
tissue sample and plasma DNA

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
RET Fusion Positive Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by NGS
Criteria

Inclusion Criteria:

  • ≥18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology
  • RET Fusion Positive
  • First Diagnosis and Treatment
  • Treatment Plan is Chemotherapy or Chemotherapy plus PD-1 antibody

Exclusion Criteria:

  • - Patients received antitumor treatment before
  • Patients with contraindication of chemotherapy
  • Pregnant or breast feeding women
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04322591


Contacts
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Contact: Yongchang Zhang, MD +8613873123436 ext 7+861383123436 zhangyongchang@csu.edu.cn
Contact: Nong Yang, MD +8613055193557 ext +8613873123436 yangnong0217@163.com

Locations
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China, Hunan
Yongchang Zhang Recruiting
Changsha, Hunan, China, 410013
Contact: Yongchang Zhang, MD    +8613873123436 ext +8613873123436    zhangyongchang@csu.edu.cn   
Sponsors and Collaborators
Hunan Province Tumor Hospital
Investigators
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Principal Investigator: Yongchang Zhang, MD Hunan Cancer Hospital
More Information
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Responsible Party: Yongchang Zhang, professor, Hunan Province Tumor Hospital
ClinicalTrials.gov Identifier: NCT04322591    
Other Study ID Numbers: POSEIDON
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yongchang Zhang, Hunan Province Tumor Hospital:
PD-L1 ;RET Fusion Lung Cancer Patients
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms