Non-small Cell Lung CancerPOSEIDONNCT04322591
Chemotherapy or Chemotherapy Plus PD-1 Antibody in RET Fusion Positive Advanced NSCLC Patitnts: the POSEIDON Trial
An observational study of Non-small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 24 Mar 2020to 24 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: RET Fusion Positive Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by NGS
Who may be able to join
- ≥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
Who cannot join
- - Patients received antitumor treatment before
- Patients with contraindication of chemotherapy
- Pregnant or breast feeding women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yongchang Zhang
Changsha, Hunan, 410013
Yongchang Zhang, MD, +8613873123436 ext. +8613873123436, zhangyongchang@csu.edu.cn
About this study
Official title: Chemotherapy or Chemotherapy Plus PD-1 Antibody in RET Fusion Positive Advanced Non-small Cell Lung Cancer ( Poseidon Study）
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.
Read the 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.
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- PD-L1 ;RET Fusion Lung Cancer Patients
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression free survival time
Measured: may 2020- may 2021 (1 year)
Secondary outcomes (2)
ORR
Overal response rate
Measured: may 2020- may 2021 (1 year)
OS
Overall survival time
Measured: may 2020- may 2021 (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start24 Mar 2020
- Primary completion24 Dec 2024 (estimated)
- Study completion24 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Province Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongchang Zhang, Hunan Province Tumor Hospital
- Investigators
- Yongchang Zhang, MD, Principal investigator, Hunan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322591
- Sponsor's protocol ID
- POSEIDON
- Acronym
- POSEIDON
- Status last verified
- Dec 2023
- First submitted
- 24 Mar 2020
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy or Chemotherapy Plus PD-1 Antibody in RET Fusion Positive Advanced Non-small Cell Lung Cancer ( Poseidon Study）
- ClinicalTrials.gov ID
- NCT04322591
- Acronym / sponsor ID
- POSEIDON / POSEIDON
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- PD-L1 ;RET Fusion Lung Cancer Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- 24 Mar 2020 (actual)
- Primary completion
- 24 Dec 2024 (estimated)
- Study completion
- 24 Mar 2025 (estimated)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- RET Fusion Positive Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by NGS
Key inclusion criteria (4 listed)
- ≥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
Key exclusion criteria (3 listed)
- - Patients received antitumor treatment before
- Patients with contraindication of chemotherapy
- Pregnant or breast feeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PFS
Time frame: may 2020- may 2021 (1 year)
Progression free survival time
2 secondary outcomes
ORR
Time frame: may 2020- may 2021 (1 year)
OS
Time frame: may 2020- may 2021 (1 year)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongchang Zhang, MD principal investigator
Hunan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongchang Zhang, MD (+8613873123436 ext. 7+861383123436, zhangyongchang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: may 2020- may 2021 (1 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.