Lung CancerNCT05636605
Analysis of the Microenvironment of Lung Cancer and Exploration of the Mechanism of Resistance to Immunotherapy
An observational study of Lung Cancer, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
The investigators plan to conduct a multiomics analysis（such as, Genomics, proteomics, single cell RNA sequencing, space transcriptomics）of tumor tissue and blood, aiming at analyzing tumor heterogeneity, mapping the microenvironment map of lung cancer and exploring the mechanism of sensitivity and resistance to… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Multiomics analysis
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Newly diagnosed lung cancer patients
Who may be able to join
- Histopathology or hemology diagnostics of lung cancer
- Patients have never received any antineoplastic therapy
Who cannot join
- Within 5 years or at the same time, there are other active malignancies
- Currently participating in interventional clinical research treatment, or received other research drugs or used research devices within 4 weeks before the first administration
- Active autoimmune diseases requiring systemic treatment (such as the use of disease relieving drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration
- The study was receiving systemic glucocorticoid treatment (excluding local glucocorticoids by nasal spray, inhalation or other means) or any other form of immunosuppressive therapy within 7 days before the first administration; Note: It is allowed to use glucocorticoid with physiological dose (prednisone ≤ 10mg/day or equivalent)
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Fourth Affiliated Hospital of Zhejiang University
Yiwu, Zhejiang, 310000
Kai Wang, PhD, 13957158572, doctorhuxi@163.com
Jiangnan Zhao, PhD, 18267098035, zjn911016@126.com
About this study
The investigators plan to conduct a multiomics analysis（such as, Genomics, proteomics, single cell RNA sequencing, space transcriptomics）of tumor tissue and blood, aiming at analyzing tumor heterogeneity, mapping the microenvironment map of lung cancer and exploring the mechanism of sensitivity and resistance to anti-PD1/PD-L1 antibodies.
Read the detailed description
Lung cancer is a highly heterogeneous disease. Cancer cells and cells within the tumor microenvironment together determine disease progression, as well as response to or escape from treatment. Tumor ecosystems are comprised of cancer cells, infiltrating immune cells, stromal cells, and other cell types together with noncellular tissue components, which interact and collectively determine disease progression as well as response to therapy. It is well known that cancer patients elicit very individualized responses to different treatments, demanding better characterization of the whole tumor ecosystem beyond currently applied clinical typing of somatic mutations in cancer cells.
Immune checkpoint blockers (ICBs) have revolutionized the management of patients with lung cancer. Blocking the interaction between the programmed cell death protein 1 (PD-1) receptor and its primary ligand (PD-L1) has demonstrated remarkable anticancer activity, and anti-PD-1/PD-L1 drugs have been approved both as single agents or in combination with cytotoxic chemotherapy. However, most patients receiving anti-PD-1/PD-L1 monoclonal antibodies do not derive benefit. Hence, there is a crucial need to identify reliable predictive biomarkers of the response to anti-PD-1/PD-L1 agents to develop precision medicine for NSCLC immunotherapy as well as to identify novel mechanisms underlying resistance to ICBs.
To map the cell type-specific landscape of cancer cells and their tumor microenvironment in lung cancer, the investigators plan to conduct a multiomics analysis（such as, Genomics, proteomics, single cell RNA sequencing, space transcriptomics）of tumor tissue and blood, aiming at analyzing tumor heterogeneity, mapping the microenvironment map of lung cancer and exploring the mechanism of sensitivity and resistance to anti-PD1/PD-L1 antibodies.
- Conditions
- Lung Cancer
- Being tested
- Multiomics analysis
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiomics analysisDiagnostic test
Genome, proteomics, single cell RNA sequencing, and space transcriptome sequencing，etc
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
Refers to the proportion of patients whose tumor shrinkage reaches a certain amount and remains for a certain period of time, including CR + PR cases
Measured: three years
Major Pathologic Response
<10% viable tumor in resected lung and lymph nodes
Measured: three-four months
progression-free survival
Patients with oncological diseases have a period of time from the start of treatment to the observation of disease progression or death due to any cause
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start1 Jan 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe 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
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kai Wang, PhD, Principal investigator, The Fourth Affiliated Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636605
- Sponsor's protocol ID
- K2022179
- Status last verified
- Dec 2022
- First submitted
- 24 Nov 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Microenvironment of Lung Cancer and Exploration of the Mechanism of Resistance to Immunotherapy
- ClinicalTrials.gov ID
- NCT05636605
- Acronym / sponsor ID
- K2022179
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Dec 2022 (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 investigators plan to conduct a multiomics analysis（such as, Genomics, proteomics, single cell RNA sequencing, space transcriptomics）of tumor tissue and blood, aiming at analyzing tumor heterogeneity, mapping the microenvironment map of lung cancer and exploring the mechanism of sensitivity and resistance to anti-PD1/PD-L1 antibodies.
Detailed description
Lung cancer is a highly heterogeneous disease. Cancer cells and cells within the tumor microenvironment together determine disease progression, as well as response to or escape from treatment. Tumor ecosystems are comprised of cancer cells, infiltrating immune cells, stromal cells, and other cell types together with noncellular tissue components, which interact and collectively determine disease progression as well as response to therapy. It is well known that cancer patients elicit very individualized responses to different treatments, demanding better characterization of the whole tumor ecosystem beyond currently applied clinical typing of somatic mutations in cancer cells.
Immune checkpoint blockers (ICBs) have revolutionized the management of patients with lung cancer. Blocking the interaction between the programmed cell death protein 1 (PD-1) receptor and its primary ligand (PD-L1) has demonstrated remarkable anticancer activity, and anti-PD-1/PD-L1 drugs have been approved both as single agents or in combination with cytotoxic chemotherapy. However, most patients receiving anti-PD-1/PD-L1 monoclonal antibodies do not derive benefit. Hence, there is a crucial need to identify reliable predictive biomarkers of the response to anti-PD-1/PD-L1 agents to develop precision medicine for NSCLC immunotherapy as well as to identify novel mechanisms underlying resistance to ICBs.
To map the cell type-specific landscape of cancer cells and their tumor microenvironment in lung cancer, the investigators plan to conduct a multiomics analysis（such as, Genomics, proteomics, single cell RNA sequencing, space transcriptomics）of tumor tissue and blood, aiming at analyzing tumor heterogeneity, mapping the microenvironment map of lung cancer and exploring the mechanism of sensitivity and resistance to anti-PD1/PD-L1 antibodies.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed lung cancer patients
Key inclusion criteria (2 listed)
- Histopathology or hemology diagnostics of lung cancer
- Patients have never received any antineoplastic therapy
Key exclusion criteria (5 listed)
- Within 5 years or at the same time, there are other active malignancies
- Currently participating in interventional clinical research treatment, or received other research drugs or used research devices within 4 weeks before the first administration
- Active autoimmune diseases requiring systemic treatment (such as the use of disease relieving drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration
- The study was receiving systemic glucocorticoid treatment (excluding local glucocorticoids by nasal spray, inhalation or other means) or any other form of immunosuppressive therapy within 7 days before the first administration; Note: It is allowed to use glucocorticoid with physiological dose (prednisone ≤ 10mg/day or equivalent)
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
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 |
|---|---|---|
| Multiomics analysisGenome, proteomics, single cell RNA sequencing, and space transcriptome sequencing，etc | Diagnostic test | – |
Primary outcome
objective response rate
Time frame: three years
Refers to the proportion of patients whose tumor shrinkage reaches a certain amount and remains for a certain period of time, including CR + PR cases
Major Pathologic Response
Time frame: three-four months
<10% viable tumor in resected lung and lymph nodes
progression-free survival
Time frame: three years
Patients with oncological diseases have a period of time from the start of treatment to the observation of disease progression or death due to any cause
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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.
Kai Wang, PhD principal investigator
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
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, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine 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 2 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: looking for participants now, as of the sponsor's last update on 20 Dec 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Wang, PhD (13957158572, doctorhuxi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: three years). The study lists 3 primary outcomes in all. 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 20 Dec 2022.