Non-Small Cell Lung CancerNCT07173244
A Real-world Study of Adebrelimab-based Combination Regimens in the Treatment of Advanced Solid Tumors
An observational study of Non-Small Cell Lung Cancer and Small Cell Lung Cancer, run by Tianjin First Central Hospital.
Trial summary
This prospective, multicenter, non-interventional, observational, real-world study was designed to evaluate the safety and efficacy of an adebrelimab-based regimen in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Gastrointestinal Cancers
- What is being tested?
- Adebrelimab
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to Sep 2029
- 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: Patients with locally advanced/recurrent or metastatic solid tumors were eligible for adebrelimab-based monotherapy or combination therapy at the investigator's discretion at the time of enrollment. Patients with central nervous system tumors, urinary system tumors, reproductive system tumors, bone tumors, soft tissue sarcomas, melanoma, and other skin tumors were excluded.
Who may be able to join
- Signed informed consent and voluntarily enrolled in this study;
- Histologically or cytologically confirmed extensive-stage small cell lung cancer;
- Patients with other types of advanced solid tumors confirmed by histology or cytology; patients who, based on currently available data, the investigator believes may benefit from adebrelimab treatment may also be considered for enrollment;
- Patients in Cohort 1 who experience disease progression and whose second-line treatment options, as assessed by the investigator, include adebrelimab in combination therapy may be enrolled in Cohort 2;
- Age 18-80 years;
- Patients deemed by the investigator to be eligible for adebrelimab monotherapy or combination therapy;
- Female patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to the first dose of study drug (Cycle 1, Day 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Females and males of childbearing potential must agree to use appropriate contraceptive methods or undergo surgical sterilization during the trial and within 90 days after the last dose of the trial drug.
- Ability to comply with study and follow-up procedures.
Who cannot join
- Women who have been confirmed to be pregnant or breastfeeding;
- Patients with histologically or cytologically confirmed central nervous system tumors, urinary system tumors, reproductive system tumors, bone tumors, soft tissue sarcomas, melanomas and other skin tumors;
- Patients with a history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
- Patients with known allergies to adebrelimab or any of its drugs and excipients;
- Patients who are deemed by the investigator to be unsuitable for participation in this study in any other circumstances, including but not limited to the following: (1) Patients with autoimmune diseases (AIDs), especially neurological AIDs, or AIDs that are moderate to severe or in active stage and cannot be controlled by immunosuppressants or require high-dose immunosuppressants to control symptoms; (2) Patients with tuberculosis infection, active tuberculosis, and suspected active TB should be examined by chest X-ray, sputum, and clinical symptoms and signs to exclude; (3) The patient has previously received or is about to receive solid organ transplantation or hematopoietic stem cell transplantation; (4) The patient needs to use large doses of antibiotics, glucocorticoids, proton pump inhibitors and other drugs for a long time.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This prospective, multicenter, non-interventional, observational, real-world study was designed to evaluate the safety and efficacy of an adebrelimab-based regimen in patients with advanced solid tumors.
Read the detailed description
This prospective, multicenter, non-interventional, observational, real-world study aims to evaluate the safety and efficacy of adebrelimab in patients with advanced solid tumors. The study is expected to enroll 300 patients with advanced solid tumors. Information on demographics, previous treatment history, adebrelimab-containing treatment regimens, clinical outcomes, and adverse events will be collected for all enrolled patients. Patients must have a clinically confirmed diagnosis of locally advanced, recurrent, or metastatic cancer, including but not limited to non-small cell lung cancer, small cell lung cancer, and gastrointestinal cancers (esophageal, gastric, liver, biliary, pancreatic, and intestinal cancers). Patients had already decided to receive adebrelimab before enrollment. Based on their tumor type, stage, and previous treatment history, they were assigned to one of two cohorts: Cohort 1: First-line treatment with adebrelimab combined with etoposide and carboplatin for extensive-stage small cell lung cancer; Cohort 2: Other solid tumors treated with an adebrelimab-based regimen (excluding central nervous system, urinary, bone, soft tissue sarcomas, and skin tumors such as melanoma). The adebrelimab regimen in Cohort 1 was 1200 mg intravenously infused every 21 days. The adebrelimab regimen in Cohort 2 was based on the instructions. Patients were followed up until loss to follow-up, death, withdrawal of consent, or study termination/closure, whichever occurred first. This study was a non-interventional, real-world study. The diagnosis and treatment process, visits, and examinations were based on routine clinical experience, and no intervention was made on patients' medication choices. The data for this study were primarily sourced from patients' daily diagnosis and treatment records.
- Being tested
- Adebrelimab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabDrug
adebrelimab-based regimen
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | adebrelimab-based regimen Receives: Drug: Adebrelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of treatment-related adverse reactions(TRAE)/immunotherapy-related adverse reactions/(irAE) and grade ≥ 3 TRAE/irAE
The rate of treatment-related adverse reactions(TRAE)/immunotherapy-related adverse reactions/(irAE) and grade ≥ 3 TRAE/irAE, based on CTAE 5.0
Measured: Through study completion, an average of 1 year
Secondary outcomes (5)
The rate of treatment Mode
The detailed treatment regimen used for enrolled patients
Measured: Through study completion, an average of 1 year
The rate of treatment Mode
The duration of drug treatment (DOT) of eroolled patients
Measured: Through study completion, an average of 1 year
The rate of Treatment efficacy
Statistical analysis of disease-free survival(PFS, median PFS, 1-year PFS rate et.al ) for different treatment regimens
Measured: Through study completion, an average of 1 year
The rate of Treatment efficacy
Statistics of overall survival(OS, median OS, 1-year OS rate et al.) of different treatment regimens
Measured: Through study completion, an average of 1 year
The rate of Treatment efficacy
Statistics on the quality of life of patients with different treatment options, according to Quality of Life Questionnare-Core 30(EORTC QLQ-C30).
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin First Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Jiang, Tianjin First Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173244
- Sponsor's protocol ID
- cancer-rws-001
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study of Adebrelimab-based Combination Regimens in the Treatment of Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07173244
- Acronym / sponsor ID
- cancer-rws-001
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tianjin First Central HospitalUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 15 Sep 2025 (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 prospective, multicenter, non-interventional, observational, real-world study was designed to evaluate the safety and efficacy of an adebrelimab-based regimen in patients with advanced solid tumors.
Detailed description
This prospective, multicenter, non-interventional, observational, real-world study aims to evaluate the safety and efficacy of adebrelimab in patients with advanced solid tumors. The study is expected to enroll 300 patients with advanced solid tumors. Information on demographics, previous treatment history, adebrelimab-containing treatment regimens, clinical outcomes, and adverse events will be collected for all enrolled patients. Patients must have a clinically confirmed diagnosis of locally advanced, recurrent, or metastatic cancer, including but not limited to non-small cell lung cancer, small cell lung cancer, and gastrointestinal cancers (esophageal, gastric, liver, biliary, pancreatic, and intestinal cancers). Patients had already decided to receive adebrelimab before enrollment. Based on their tumor type, stage, and previous treatment history, they were assigned to one of two cohorts: Cohort 1: First-line treatment with adebrelimab combined with etoposide and carboplatin for extensive-stage small cell lung cancer; Cohort 2: Other solid tumors treated with an adebrelimab-based regimen (excluding central nervous system, urinary, bone, soft tissue sarcomas, and skin tumors such as melanoma). The adebrelimab regimen in Cohort 1 was 1200 mg intravenously infused every 21 days. The adebrelimab regimen in Cohort 2 was based on the instructions. Patients were followed up until loss to follow-up, death, withdrawal of consent, or study termination/closure, whichever occurred first. This study was a non-interventional, real-world study. The diagnosis and treatment process, visits, and examinations were based on routine clinical experience, and no intervention was made on patients' medication choices. The data for this study were primarily sourced from patients' daily diagnosis and treatment records.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Drug: Adebrelimabadebrelimab-based regimen |
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/recurrent or metastatic solid tumors were eligible for adebrelimab-based monotherapy or combination therapy at the investigator's discretion at the time of enrollment. Patients with central nervous system tumors, urinary system tumors, reproductive system tumors, bone tumors, soft tissue sarcomas, melanoma, and other skin tumors were excluded.
Key inclusion criteria (8 listed)
- Signed informed consent and voluntarily enrolled in this study;
- Histologically or cytologically confirmed extensive-stage small cell lung cancer;
- Patients with other types of advanced solid tumors confirmed by histology or cytology; patients who, based on currently available data, the investigator believes may benefit from adebrelimab treatment may also be considered for enrollment;
- Patients in Cohort 1 who experience disease progression and whose second-line treatment options, as assessed by the investigator, include adebrelimab in combination therapy may be enrolled in Cohort 2;
- Age 18-80 years;
Key exclusion criteria (5 listed)
- Women who have been confirmed to be pregnant or breastfeeding;
- Patients with histologically or cytologically confirmed central nervous system tumors, urinary system tumors, reproductive system tumors, bone tumors, soft tissue sarcomas, melanomas and other skin tumors;
- Patients with a history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
- Patients with known allergies to adebrelimab or any of its drugs and excipients;
- Patients who are deemed by the investigator to be unsuitable for participation in this study in any other circumstances, including but not limited to the following: (1) Patients with autoimmune diseases (AIDs), especially neurological AIDs, or AIDs that are moderate to severe or in active stage and cannot be controlled by immunosuppressants or require high-dose immunosuppressants to control symptoms; (2) Patients with tuberculosis infection, active tuberculosis, and suspected active TB should be examined by chest X-ray, sputum, and clinical symptoms and signs to exclude; (3) The patient has previously received or is about to receive solid organ transplantation or hematopoietic stem cell transplantation; (4) The patient needs to use large doses of antibiotics, glucocorticoids, proton pump inhibitors and other drugs for a long time.
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 |
|---|---|---|
| Adebrelimabadebrelimab-based regimen | Drug | Arm 1 |
Primary outcome
The rate of treatment-related adverse reactions(TRAE)/immunotherapy-related adverse reactions/(irAE) and grade ≥ 3 TRAE/irAE
Time frame: Through study completion, an average of 1 year
The rate of treatment-related adverse reactions(TRAE)/immunotherapy-related adverse reactions/(irAE) and grade ≥ 3 TRAE/irAE, based on CTAE 5.0
5 secondary outcomes
The rate of treatment Mode
Time frame: Through study completion, an average of 1 year
The rate of treatment Mode
Time frame: Through study completion, an average of 1 year
The rate of Treatment efficacy
Time frame: Through study completion, an average of 1 year
The rate of Treatment efficacy
Time frame: Through study completion, an average of 1 year
The rate of Treatment efficacy
Time frame: Through study completion, an average of 1 year
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 15 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer and Small Cell Lung Cancer, run by Tianjin First Central Hospital.
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 8 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: opening soon, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Wei Jiang Tianjin First Central Hospital, Professor (130 7220 1699, wangguohuipku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of treatment-related adverse reactions(TRAE)/immunotherapy-related adverse reactions/(irAE) and grade ≥ 3 TRAE/irAE (time frame: Through study completion, an average of 1 year). 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 15 Sep 2025.