SCLC,Extensive StageMOSAICNCT05933863
Molecular Subtyping of Extensive Stage Small Cell Lung Cancer and Relevent Clinical Significance
An observational study of SCLC,Extensive Stage, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
To validate the predictive value of transcriptome-based molecular subtyping of extensive stage small cell lung cancer (SCLC) for the efficacy of programmed death-1(PD-1)/programmed death-ligand1(PD-L1) inhibitor in the first line setting; to explore the differences of immune microenvironment between different SCLC… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- SCLC,Extensive Stage
- What is being tested?
- PD-(L)1 antibody immunotherapy
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 29 Mar 2022to 1 Dec 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study includes adults (18-100 years) with untreated advanced SCLC. Eligible patients have an ECOG score of 0~2, an expected survival >3 months, and can provide tumor biopsy samples for transcripsome testing. They must have received first-line chemotherapy or chemotherapy combined with a PD-L1 inhibitor. Participants are divided into two arms: Chemotherapy (80-100 cases) and Immunotherapy+chemotherapy (80-100 cases). Exclusion criteria include intolerance to chemotherapy, inability to provide tumor tissue samples, presence/history of other malignant tumors, and other reasons deeming them unfit for the study.
Who may be able to join
- The enrolled subjects shall meet all the following conditions at the same time.
- Male or female, aged 18 to 100 years
- Patients with untreated advanced small cell lung cancer clearly diagnosed by histopathology
- Be able to provide tumor biopsy tissue sample for molecular analysis
- Eastern Cooperative oncology Group (ECOG) score: 0~2
- Expected survival of more than 3 months.
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- Has at least 1 measurable or evaluable tumor lesion with a longest diameter ≥ 10 mm at baseline (in case of lymph nodes, a shortest diameter ≥ 15 mm is required) according to RECIST v1.1
- Received first-line chemotherapy or chemotherapy＋PD-(L)1 inhibitor and be able to provide complete treatment information and efficacy evaluation results.
- Voluntary signed informed consent and expected good compliance.
Who cannot join
- Those meeting any of the following conditions may not be included.
- Patient unable to tolerate chemotherapy.
- Patients unable to provide tumor tissue samples for testing
- Patients with other malignant tumors or a history of other malignant tumors
- Patients have any other reason to be unfit to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, 100042
About this study
To validate the predictive value of transcriptome-based molecular subtyping of extensive stage small cell lung cancer (SCLC) for the efficacy of programmed death-1(PD-1)/programmed death-ligand1(PD-L1) inhibitor in the first line setting; to explore the differences of immune microenvironment between different SCLC subtypes to reveal the mechanisms of immunotherapy resistance of SCLC
Read the detailed description
This retrospective observational study examines the predictive value of transcriptome-based molecular subtyping of extensive stage SCLC for PD-1/PD-L1 inhibitor efficacy and explores immune microenvironment differences between subtypes to uncover immunotherapy resistance mechanisms. Patients with extensive stage SCLC receiving first-line standard treatment are enrolled, and baseline tumor tissue and peripheral blood samples are collected for transcriptome sequencing and immunohistochemistry (IHC). Based on results, patients are classified into four molecular subtypes, and treatment efficacy and safety are recorded. The study compares the efficacy between SCLC subtypes to determine if molecular typing predicts immunotherapy efficacy and investigates immune microenvironment differences between subtypes to uncover resistance mechanisms. Treatment regimens follow first-line extensive stage SCLC guidelines, including cisplatin+etoposide or carboplatin+etoposide and PD-(L)1 inhibitors, with options determined by the supervising physician.
- Conditions
- SCLC,Extensive Stage
- Being tested
- PD-(L)1 antibody immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-(L)1 antibody immunotherapyDrug
The treatment regimen involved in this study follows guidelines for the first-line treatment of extensive stage SCLC: cisplatin+etoposide or carboplatin+etoposide and PD-(L)1 inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| immunotherapy cohort | Extensive stage SCLC patients receiving first-line chemotherapy plus PD-(L)1 antibody treatment will be enrolled in this cohort. Baseline tumor tissue samples and peripheral blood samples will be collected for transcriptome and immunohistochemistry analysis etc. Receives: Drug: PD-(L)1 antibody immunotherapy | |
| chemotherapy cohort | Extensive stage SCLC patients receiving only first-line etoposide plus platinum chemotherapy will be enrolled in this cohort. Baseline tumor tissue samples and peripheral blood samples will be collected for transcriptome and immunohistochemistry analysis etc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
From the start of first-line treatment until disease progression or death due to any cause
Measured: 2022.4.1-2023.12.31
Secondary outcomes (3)
Overall survival
From the start of first-line treatment until death due to any cause
Measured: 2022.4.10-2024.12.31
Objective response rate
The tumor size was calculated by computed tomography or magnetic resonance Imaging scan, the best response was evaluated based on Response Evaluation Criteria in Solid Tumors (RECISTVersion1.1)
Measured: 2022.4.10-2023.12.31
molecular subtyping and tumor microenvironment biomarkers
The molecular subtyping was carried out based on transcripsome sequencing following the method in published article PMID: 33482121, the tumor microenvironment biomarkers include tumor infiltrated immune cells and specific gene expression evaluated by transcripsome and Multiplex immunohistochemical analysis etc.
Measured: 2022.4.10-2023.12.31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start29 Mar 2022
- Primary completion18 Jul 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLC,Extensive StageStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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-control
- Time perspective
- Retrospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Minglei Zhuo, Physician, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933863
- Sponsor's protocol ID
- 2021YJZ97
- Acronym
- MOSAIC
- Status last verified
- Nov 2024
- First submitted
- 24 Jun 2023
- Last updated
- 16 Dec 2024
- 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 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Subtyping of Extensive Stage Small Cell Lung Cancer and Relevent Clinical Significance
- ClinicalTrials.gov ID
- NCT05933863
- Acronym / sponsor ID
- MOSAIC / 2021YJZ97
- Conditions
- SCLC,Extensive Stage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 18 Jul 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 6 Jul 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.
To validate the predictive value of transcriptome-based molecular subtyping of extensive stage small cell lung cancer (SCLC) for the efficacy of programmed death-1(PD-1)/programmed death-ligand1(PD-L1) inhibitor in the first line setting; to explore the differences of immune microenvironment between different SCLC subtypes to reveal the mechanisms of immunotherapy resistance of SCLC
Detailed description
This retrospective observational study examines the predictive value of transcriptome-based molecular subtyping of extensive stage SCLC for PD-1/PD-L1 inhibitor efficacy and explores immune microenvironment differences between subtypes to uncover immunotherapy resistance mechanisms. Patients with extensive stage SCLC receiving first-line standard treatment are enrolled, and baseline tumor tissue and peripheral blood samples are collected for transcriptome sequencing and immunohistochemistry (IHC). Based on results, patients are classified into four molecular subtypes, and treatment efficacy and safety are recorded. The study compares the efficacy between SCLC subtypes to determine if molecular typing predicts immunotherapy efficacy and investigates immune microenvironment differences between subtypes to uncover resistance mechanisms. Treatment regimens follow first-line extensive stage SCLC guidelines, including cisplatin+etoposide or carboplatin+etoposide and PD-(L)1 inhibitors, with options determined by the supervising physician.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immunotherapy cohort | – | Drug: PD-(L)1 antibody immunotherapyExtensive stage SCLC patients receiving first-line chemotherapy plus PD-(L)1 antibody treatment will be enrolled in this cohort. Baseline tumor tissue samples and peripheral blood samples will be collected for transcriptome and immunohistochemistry analysis etc. |
| chemotherapy cohort | – | –Extensive stage SCLC patients receiving only first-line etoposide plus platinum chemotherapy will be enrolled in this cohort. Baseline tumor tissue samples and peripheral blood samples will be collected for transcriptome and immunohistochemistry analysis etc. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes adults (18-100 years) with untreated advanced SCLC. Eligible patients have an ECOG score of 0~2, an expected survival >3 months, and can provide tumor biopsy samples for transcripsome testing. They must have received first-line chemotherapy or chemotherapy combined with a PD-L1 inhibitor. Participants are divided into two arms: Chemotherapy (80-100 cases) and Immunotherapy+chemotherapy (80-100 cases). Exclusion criteria include intolerance to chemotherapy, inability to provide tumor tissue samples, presence/history of other malignant tumors, and other reasons deeming them unfit for the study.
Key inclusion criteria (9 listed)
- The enrolled subjects shall meet all the following conditions at the same time.
Key exclusion criteria (5 listed)
- Those meeting any of the following conditions may not be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD-(L)1 antibody immunotherapyThe treatment regimen involved in this study follows guidelines for the first-line treatment of extensive stage SCLC: cisplatin+etoposide or carboplatin+etoposide and PD-(L)1 inhibitor. | Drug | immunotherapy cohort |
Primary outcome
Progression-free survival
Time frame: 2022.4.1-2023.12.31
From the start of first-line treatment until disease progression or death due to any cause
3 secondary outcomes
Overall survival
Time frame: 2022.4.10-2024.12.31
Objective response rate
Time frame: 2022.4.10-2023.12.31
molecular subtyping and tumor microenvironment biomarkers
Time frame: 2022.4.10-2023.12.31
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
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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.
Minglei Zhuo, Physician principal investigator
Peking University Cancer Hospital & Institute
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 SCLC,Extensive Stage, run by Peking University Cancer Hospital & Institute 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 9 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: finished, as of the sponsor's last update on 16 Dec 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 2022.4.1-2023.12.31). 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 16 Dec 2024.