NSCLCNSCLCNCT04741633
Multi Dimensional Precise Exploration of Immunoconsolidation Therapy for Locally Advanced NSCLC After Chemo-radiotherapy
An observational study of NSCLC and Chemoradiotherapy, run by Fudan University at 1 site in China.
Trial summary
The purpose of this study is to carry out a prospective observational study in patients with locally advanced NSCLC receiving radical concurrent chemoradiotherapy and follow-up immune consolidation therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- NSCLC, Chemoradiotherapy, ctDNA
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 31 Dec 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with locally advanced NSCLC receiving radical concurrent chemoradiotherapy and subsequent immunoconsolidation therapy
Who may be able to join
- Non small cell lung cancer patients confirmed by pathology;
- They were 18-80 years old;
- The tumor could not be resected or could not tolerate surgery;
- Planed to receive chemoradiotherapy and subsequent immunoconsolidation therapy;
- Clinical stage III (AJCC, 8th Edition, 2017);
- After systematic detection of non-small cell lung cancer core indicators including EGFR, ALK, ros1, KRAS, ntrk, TMB, etc;
- Patient informed consent.
Who cannot join
- After radiotherapy and chemotherapy, the disease progressed and immune maintenance therapy could not be carried out
- It can not cooperate with the completion of baseline mutation screening and subsequent sample detection
- Factors judged by other researchers not suitable for further study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xi Yang, Phd, +86 17321296901, ntgeroge@qq.com
About this study
Official title: Multi Dimensional Precise Exploration of Immunoconsolidation Therapy for Locally Advanced Non-small Cell Lung Cancer After Chemo-radiotherapy
The purpose of this study is to carry out a prospective observational study in patients with locally advanced NSCLC receiving radical concurrent chemoradiotherapy and follow-up immune consolidation therapy. By detecting ctDNA and TILs of the patients, we explored the value of blood dynamic monitoring of ctDNA in patients with prognosis stratification and treatment effect, and explored the patients before and after concurrent chemoradiotherapy and immune consolidation therapy The characteristics of DNA, RNA, T cells and other biomarkers were correlated with the efficacy and prognosis.
- Conditions
- NSCLC, Chemoradiotherapy, ctDNA
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between ctDNA dynamic detection and 1-year PFS rate after chemoradiotherapy
The ctDNA dynamic detection will contain NGS test including mutations(both somatic and germline), copy number variations, gene fusions along with genetic interpretation for each and every mutation identified in each test(both blood and tissue) during the whole therapeutic process
Measured: Six months after consolidation treatment
Secondary outcomes (2)
PFS
Measured: Six months after consolidation treatment
OS
Measured: Six months after consolidation treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start1 Apr 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhengfei Zhu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741633
- Sponsor's protocol ID
- CID-001
- Acronym
- NSCLC
- Status last verified
- Feb 2021
- First submitted
- 2 Jan 2021
- Last updated
- 5 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Dimensional Precise Exploration of Immunoconsolidation Therapy for Locally Advanced Non-small Cell Lung Cancer After Chemo-radiotherapy
- ClinicalTrials.gov ID
- NCT04741633
- Acronym / sponsor ID
- NSCLC / CID-001
- Conditions
- NSCLC, Chemoradiotherapy, ctDNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 5 Feb 2021 (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.
The purpose of this study is to carry out a prospective observational study in patients with locally advanced NSCLC receiving radical concurrent chemoradiotherapy and follow-up immune consolidation therapy. By detecting ctDNA and TILs of the patients, we explored the value of blood dynamic monitoring of ctDNA in patients with prognosis stratification and treatment effect, and explored the patients before and after concurrent chemoradiotherapy and immune consolidation therapy The characteristics of DNA, RNA, T cells and other biomarkers were correlated with the efficacy and prognosis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced NSCLC receiving radical concurrent chemoradiotherapy and subsequent immunoconsolidation therapy
Key inclusion criteria (7 listed)
- Non small cell lung cancer patients confirmed by pathology;
- They were 18-80 years old;
- The tumor could not be resected or could not tolerate surgery;
- Planed to receive chemoradiotherapy and subsequent immunoconsolidation therapy;
- Clinical stage III (AJCC, 8th Edition, 2017);
Key exclusion criteria (3 listed)
- After radiotherapy and chemotherapy, the disease progressed and immune maintenance therapy could not be carried out
- It can not cooperate with the completion of baseline mutation screening and subsequent sample detection
- Factors judged by other researchers not suitable for further study
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
Correlation between ctDNA dynamic detection and 1-year PFS rate after chemoradiotherapy
Time frame: Six months after consolidation treatment
The ctDNA dynamic detection will contain NGS test including mutations(both somatic and germline), copy number variations, gene fusions along with genetic interpretation for each and every mutation identified in each test(both blood and tissue) during the whole therapeutic process
2 secondary outcomes
PFS
Time frame: Six months after consolidation treatment
OS
Time frame: Six months after consolidation treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
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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.
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 NSCLC and Chemoradiotherapy, run by Fudan University 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 7 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 5 Feb 2021. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between ctDNA dynamic detection and 1-year PFS rate after chemoradiotherapy (time frame: Six months after consolidation treatment). 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 5 Feb 2021.