BiomarkersNCT04858828
Investigation on Predictive Molecular Markers of Efficacy for Front-line Immunochemotherapy in Advanced NSCLC
An observational study of Biomarkers, run by Zhou Chengzhi at 1 site in China.
Trial summary
This project is a real-world exploratory study aiming to explore potential molecular markers detectable at baseline that can enable the prediction of clinical efficacy of front-line immunotherapy combined with chemotherapy in advanced non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biomarkers
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 1 Mar 2024
- 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
- Adult, Older adult
Study population: Patients with advanced NSCLC eligible for front-line treatment of immunotherapy combined with chemotherapy.
Who may be able to join
- Patients who are clinically diagnosed with stage IV NSCLC;
- Patients who submitted samples for molecular testing using the OncoScreen Plus panel and PD-L1 (22C3) immunohistochemistry test at baseline;
- Patients with negative results for sensitizing mutations for 6 genes, including EGFR, ALK, ROS1, BRAF, MET exon 14 skipping, and RET;
- Patients without contraindications for immunotherapy;
- Patients who are 18 years or older at the time of signing the informed consent form;
- Patients with life expectancy of at least 12 weeks;
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- Patients with ECOG score of 0 or 1;
- Patients with adequate organ function defined by the following criteria:
- Absolute neutrophil count ≥ 1.5109/L;
- Platelets ≥ 90109/L;
- Hemoglobin ≥ 9.0g/dL;
- Albumin levels ≥2.8 g/L;
- Total serum bilirubin ≤ 1.5 the upper limit of normal (ULN); for patients with liver metastases, total bilirubin ≤ 2 ULN;
- Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ULN; for patients with liver metastases, ALT and AST ≤ 5ULN;
- Serum creatinine ≤ 1.5 ULN;
- International normalized ratio (INR) or plasma prothrombin time (PT) ≤1.5ULN.
Who cannot join
- Patients with other concurrent tumors;
- Patients with other concurrent medical conditions that may affect their follow-up and short-term survival;
- Patients with any history of immunotherapy;
- Patients with any history of chemotherapy, radiotherapy or other anti-tumor treatments;
- Patients with heart function classified as New York Heart Association (NYHA) class III or IV;
- Patients with peripheral nerve disease;
- Patients with confirmed hearing loss;
- Patients with other conditions deemed unsuitable for enrollment by the researchers.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhou Chengzhi
Guangzhou, Guangdong, 510120
Chengzhi Zhou, Professor, 13560351186, doctorzcz@163.com
About this study
Official title: Investigation on Molecular Markers Associated With the Clinical Efficacy of Immunotherapy Combined With Chemotherapy in the First-line Treatment of Patients With Advanced Non-small-cell Lung Cancer
This project is a real-world exploratory study aiming to explore potential molecular markers detectable at baseline that can enable the prediction of clinical efficacy of front-line immunotherapy combined with chemotherapy in advanced non-small cell lung cancer (NSCLC). This study aims to include a total of 200 treatment-naïve patients initially diagnosed with advanced NSCLC. Paired tissue and blood samples collected from all patients before the start of immunochemotherapy treatment (baseline) will be analyzed. The patient samples will be submitted for molecular analysis, including next-generation sequencing (NGS)-based gene expression profiling (GEP) and inflammation-related T-cell receptor (TCR) repertoire profiling. The molecular assay results will include but will not be limited to tumor mutation burden (TMB), microsatellite instability (MSI) status, DNA damage repair (DDR)-related gene mutation status, and programmed death-ligand 1 (PD-L1) expression level. Patients will be followed-up for treatment responses until radiological confirmation of disease progression to first-line immunochemotherapy. The molecular assay results will then be analyzed with clinical data including objective responses and progression-free survival outcomes, among others, to identify molecular markers at baseline that are associated with clinical efficacy of immunochemotherapy.
- Conditions
- Biomarkers
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation on molecular markers associated with the clinical efficacy of immunotherapy combined with chemotherapy in the first-line treatment of patients with advanced non-small-cell lung cancer
Next-generation sequencing (NGS)-based gene expression profiling (GEP) and inflammation-related T-cell receptor (TCR) repertoire profiling. The molecular assay results will include but will not be limited to tumor mutation burden (TMB), microsatellite instability (MSI) status, DNA damage repair (DDR)-related gene mutation status, and programmed death-ligand 1 (PD-L1) expression level.
Measured: June 2021 - March 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiomarkersStudies 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhou Chengzhi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhou Chengzhi, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858828
- Sponsor's protocol ID
- CROC2101
- Status last verified
- Apr 2021
- First submitted
- 22 Apr 2021
- Last updated
- 26 Apr 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 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on Molecular Markers Associated With the Clinical Efficacy of Immunotherapy Combined With Chemotherapy in the First-line Treatment of Patients With Advanced Non-small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04858828
- Acronym / sponsor ID
- CROC2101
- Conditions
- Biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhou ChengzhiUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 26 Apr 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.
This project is a real-world exploratory study aiming to explore potential molecular markers detectable at baseline that can enable the prediction of clinical efficacy of front-line immunotherapy combined with chemotherapy in advanced non-small cell lung cancer (NSCLC). This study aims to include a total of 200 treatment-naïve patients initially diagnosed with advanced NSCLC. Paired tissue and blood samples collected from all patients before the start of immunochemotherapy treatment (baseline) will be analyzed. The patient samples will be submitted for molecular analysis, including next-generation sequencing (NGS)-based gene expression profiling (GEP) and inflammation-related T-cell receptor (TCR) repertoire profiling. The molecular assay results will include but will not be limited to tumor mutation burden (TMB), microsatellite instability (MSI) status, DNA damage repair (DDR)-related gene mutation status, and programmed death-ligand 1 (PD-L1) expression level. Patients will be followed-up for treatment responses until radiological confirmation of disease progression to first-line immunochemotherapy. The molecular assay results will then be analyzed with clinical data including objective responses and progression-free survival outcomes, among others, to identify molecular markers at baseline that are associated with clinical efficacy of immunochemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced NSCLC eligible for front-line treatment of immunotherapy combined with chemotherapy.
Key inclusion criteria (16 listed)
- Patients who are clinically diagnosed with stage IV NSCLC;
- Patients who submitted samples for molecular testing using the OncoScreen Plus panel and PD-L1 (22C3) immunohistochemistry test at baseline;
- Patients with negative results for sensitizing mutations for 6 genes, including EGFR, ALK, ROS1, BRAF, MET exon 14 skipping, and RET;
- Patients without contraindications for immunotherapy;
- Patients who are 18 years or older at the time of signing the informed consent form;
Key exclusion criteria (8 listed)
- Patients with other concurrent tumors;
- Patients with other concurrent medical conditions that may affect their follow-up and short-term survival;
- Patients with any history of immunotherapy;
- Patients with any history of chemotherapy, radiotherapy or other anti-tumor treatments;
- Patients with heart function classified as New York Heart Association (NYHA) class III or IV;
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
Investigation on molecular markers associated with the clinical efficacy of immunotherapy combined with chemotherapy in the first-line treatment of patients with advanced non-small-cell lung cancer
Time frame: June 2021 - March 2024
Next-generation sequencing (NGS)-based gene expression profiling (GEP) and inflammation-related T-cell receptor (TCR) repertoire profiling. The molecular assay results will include but will not be limited to tumor mutation burden (TMB), microsatellite instability (MSI) status, DNA damage repair (DDR)-related gene mutation status, and programmed death-ligand 1 (PD-L1) expression level.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 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 Biomarkers, run by Zhou Chengzhi 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 16 inclusion and 8 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 26 Apr 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?
Contact Chengzhi Zhou (13560351186, doctorzcz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigation on molecular markers associated with the clinical efficacy of immunotherapy combined with chemotherapy in the first-line treatment of patients with advanced non-small-cell lung cancer (time frame: June 2021 - March 2024). 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 26 Apr 2021.