Lung Cancer, Nonsmall CellNCT05725915
Prediction Model of ICIs Combined With Chemotherapy in Advanced NSCLC
An observational study of Lung Cancer, Nonsmall Cell, run by Beijing Red Clove Public Welfare Development Center at 1 site in China.
Trial summary
The reliable predictive markers to identify which patients with advanced non-small cell lung cancer tumors will achieve durable clinical benefit for chemo-immunotherapy are needed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Nonsmall Cell
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 1 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: Patients diagnosed with inoperable stage IIIB to IV NSCLS using immune checkpoint inhibitors in combination with chemotherapy.
Who may be able to join
- Male and female, ≥18 years old;
- Patients with a definite cytological or histopathological diagnosis of non-small cell lung cancer;
- Locally advanced (stage IIIB/IIIC) or metastatic (stage IV) NSCLC unable to receive radical surgery and/or radical radiotherapy (with or without concurrent chemotherapy) (AJCC cancer stage 8 clinical stage)
- There is no known ALK gene translocation
- For patients with EGFR-negative non-squamous cell carcinoma, or patients with EGFR-negative/unknown squamous cell carcinoma, it is required that they have not received systemic antitumor therapy for advanced NSCLC in the past (patients have received neoadjuvant chemotherapy, adjuvant chemotherapy, radiotherapy or chemoradiotherapy for curing non-metastatic disease in the past, A disease-free interval of ≥6 months was required between the last chemotherapy and/or radiotherapy).
- Patients with non-squamous cell carcinoma with EGFR-sensitive mutation and EGFR TKI progression could be enrolled if they met any of the following requirements:
Show all 11Show fewer
- Progress in Treatment of 1/2 generation EGFR TKI, T790M-; EGFR TKI treatment progress of 1/2 generation, T790M+, after 3 generations of EGFR TKI treatment progress again; T790M status was not considered in patients who had progressed to the initial 3 generations of EGFR TKI therapy.
- At least 1 measurable lesion according to RECIST 1.1
- Receiving immune checkpoint inhibitor therapy for more than 2 cycles
- ECOG PS 0-1 score
- Be able to understand and abide by the requirements of the agreement, and voluntarily participate in the study.
Who cannot join
- Patients participating in other clinical studies;
- Patients with serious lack of diagnosis and treatment data;
- Patients could not understand the purpose of the study or disagreed with the requirements of the study;
- A history of other tumors within 5 years;
- Patients judged by the researchers as not suitable for inclusion in this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shuhua Han
Nanjing, Jiangsu
Shuhua Han, docter, 13585148267, hanshuhua0922@126.com
About this study
Official title: Multiparameter Prediction Model of Immune Checkpoint Inhibitors Combined With Chemotherapy in Advanced Non-small Cell Lung Cancer: a Real-world Study
The reliable predictive markers to identify which patients with advanced non-small cell lung cancer tumors will achieve durable clinical benefit for chemo-immunotherapy are needed. This study is a real world study, aiming to establish a multi-parameter model to predict the efficacy of immune checkpoint inhibitor(ICI) combined with chemotherapy, and to explore the correlation and predictive value of each single biomarker, so as to assist physician to select patients who may benefit for a long time as early as possible and guide clinical accurate treatment.
- Conditions
- Lung Cancer, Nonsmall Cell
- 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.
Progression-free survival（PFS）in days
the time between the time a patient with tumor disease begins treatment and the time when disease progression is observed or death from any cause occurs.
Measured: From date of enrollment until the date of first documented progression, assessed up to 2 years.
Secondary outcomes (1)
ctDNA in concentration
The best predictive value of ctDNA concentration change threshold and the best collection time.
Measured: The First treatment (month 1), the second treatment (month 2) and the time of progression (assessed up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Dec 2022
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Nonsmall CellStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Red Clove Public Welfare Development Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuhua Han, docter, Study chair, Southeast University Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725915
- Sponsor's protocol ID
- BJ-HDX-20220781
- Status last verified
- Jan 2023
- First submitted
- 16 Jan 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is the initial stage of the study, and the data sets generated and analyzed in the later stage of the study can be obtained from corresponding authors according to reasonable requirements.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparameter Prediction Model of Immune Checkpoint Inhibitors Combined With Chemotherapy in Advanced Non-small Cell Lung Cancer: a Real-world Study
- ClinicalTrials.gov ID
- NCT05725915
- Acronym / sponsor ID
- BJ-HDX-20220781
- Conditions
- Lung Cancer, Nonsmall Cell
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Beijing Red Clove Public Welfare Development CenterUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 13 Feb 2023 (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 reliable predictive markers to identify which patients with advanced non-small cell lung cancer tumors will achieve durable clinical benefit for chemo-immunotherapy are needed. This study is a real world study, aiming to establish a multi-parameter model to predict the efficacy of immune checkpoint inhibitor(ICI) combined with chemotherapy, and to explore the correlation and predictive value of each single biomarker, so as to assist physician to select patients who may benefit for a long time as early as possible and guide clinical accurate treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with inoperable stage IIIB to IV NSCLS using immune checkpoint inhibitors in combination with chemotherapy.
Key inclusion criteria (11 listed)
- Male and female, ≥18 years old;
- Patients with a definite cytological or histopathological diagnosis of non-small cell lung cancer;
- Locally advanced (stage IIIB/IIIC) or metastatic (stage IV) NSCLC unable to receive radical surgery and/or radical radiotherapy (with or without concurrent chemotherapy) (AJCC cancer stage 8 clinical stage)
- There is no known ALK gene translocation
- For patients with EGFR-negative non-squamous cell carcinoma, or patients with EGFR-negative/unknown squamous cell carcinoma, it is required that they have not received systemic antitumor therapy for advanced NSCLC in the past (patients have received neoadjuvant chemotherapy, adjuvant chemotherapy, radiotherapy or chemoradiotherapy for curing non-metastatic disease in the past, A disease-free interval of ≥6 months was required between the last chemotherapy and/or radiotherapy).
Key exclusion criteria (5 listed)
- Patients participating in other clinical studies;
- Patients with serious lack of diagnosis and treatment data;
- Patients could not understand the purpose of the study or disagreed with the requirements of the study;
- A history of other tumors within 5 years;
- Patients judged by the researchers as not suitable for inclusion in this 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
Progression-free survival（PFS）in days
Time frame: From date of enrollment until the date of first documented progression, assessed up to 2 years.
the time between the time a patient with tumor disease begins treatment and the time when disease progression is observed or death from any cause occurs.
1 secondary outcome
ctDNA in concentration
Time frame: The First treatment (month 1), the second treatment (month 2) and the time of progression (assessed up to 2 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: Undecided. This is the initial stage of the study, and the data sets generated and analyzed in the later stage of the study can be obtained from corresponding authors according to reasonable requirements.
Related trials for Lung Cancer, Nonsmall Cell
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Shuhua Han, docter study chair
Southeast University Zhongda 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 Lung Cancer, Nonsmall Cell, run by Beijing Red Clove Public Welfare Development Center 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 11 inclusion and 5 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 13 Feb 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 Shuhua Han, docter (13585148267, hanshuhua0922@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival（PFS）in days (time frame: From date of enrollment until the date of first documented progression, assessed up to 2 years.). 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 13 Feb 2023.