NSCLCPhase 2NCT06480136
SHR-A1921 Combined With Adebrelimab in the Treatment of Advanced NSCLC Who Failed the Previous Standard First-line Treatment
A Phase 2 study testing SHR-A1921 injection and adebrelimab injection in people with NSCLC, run by Shanghai Pulmonary Hospital, Shanghai, China.
Trial summary
This is a Phase II clinical study to evaluate the efficacy and safety of SHR-A1921 conbined with adebrelimab in advanced NSCLC who failed the previous first-line standard therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- SHR-A1921 injection and adebrelimab injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2024to 15 Feb 2028
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to join in this study, signed informed consent, good adherence, can cooperate with the follow-up;
- Age 18-75 years old, both genders;
- Patients with histologically or cytologically confirmed advanced or metastatic NSCLC（Advanced stage is defined as stage IIIb-IV according to the 8th edition of the IASLC TNM staging criteria), and no longer suitable for radical surgery or radiotherapy combined with chemotherapy；
- Participants with nonsquamous tumors were required to have available genetic testing to confirm without EGFR, ALK, or ROS1 driver mutations;
- Disease progression after prior immunization (PD-1/L1 antibody)or combined with platinum-based chemotherapy;
- At least one measurable lesion that met RECIST v1.1 criteria;
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- ECOG Performance Status of 0-1;
- Must have life-expectancy of ≥ 12 weeks;
- Adequate function of marrow and major organs meets the following requirements：
- Blood routine (no blood transfusion or granulocyte colony-stimulating factor therapy within 14 days before examination)：ANC≥1.5×109/L；PLT≥75×109/L；Hb≥90 g/L;
- Liver function (no hepatoprotective drugs within 7 days before the examination): ALT and AST≤3 × ULN (liver metastasis≤5.0 × ULN); TBIL≤1.5 × ULN（Gilbert's syndrome subjects: TBIL≤3mg/dL）;
- Renal function:Cr≤1.5 × ULN or creatinine clearance ≥60 mL / min (Cockcroft-Gault formula)；
- Coagulation: INR or PT≤1.5×ULN，APTT≤1.5×ULN；
- Cardiac ultrasound: LVEF≥50%;
- Female patients of childbearing age or male patients whose partner was a female of childbearing age had to consent to use a highly effective method of contraception for the duration of the study and for 6 months after the last dose of study drug; and have no plans to have children or to donate sperm or eggs, Childbearing age female patients who were not surgically sterilized had to undergo a serum pregnancy test with a negative result within 7 days before starting study treatment.；
Who cannot join
- Previous receipt of any drug containing a topoisomerase I inhibitor drug, including antibody-drug conjugates;
- Previous receipt of TROP2-targeted therapy;
- Grade 3 or above immune-related adverse events occurred during previous immunotherapy, such as immune-related interstitial lung disease, immune-related myocarditis, immune hepatitis, etc.
- More than 10% of the tumor tissue was histologically or cytologically confirmed as small-cell lung cancer, neuroendocrine carcinoma, carcinosarcoma;
- Untreated brain metastasis, or associated with meningeal metastasis, spinal cord compression, etc. Patients who had received previous treatment for brain metastases (radiotherapy or surgery) were eligible for enrollment if they had been stable for at least 4 weeks as confirmed by imaging and had been free of systemic hormone therapy (at a dose of >10 mg per day of prednisone or the equivalent) for more than 2 weeks and were asymptomatic;
- Spinal cord compression that could not be cured by surgery and/or radiotherapy;
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- Patients with uncontrolled cancer-related pain as judged by the investigator;
- Patients with symptomatic pleural effusion, pericardial effusion, or ascites requiring drainage or those who had undergone therapeutic drainage of serous effusion within 2 weeks before the administration of the study drug;
- Patients who received anti-tumor therapy such as chemotherapy within 4 weeks before the first dose of medication, or received lung field radiotherapy >30Gy within 6 months before the first dose of medication;
- Major organ surgery or major trauma within 4 weeks before the first dose of the study drug;
- Other malignant tumors occurred within 5 years before the first treatment;
- Patients with a history of interstitial lung disease such as idiopathic pulmonary fibrosis or imaging examination at screening that suspected interstitial pneumonia or could not rule out interstitial pneumonia;
- Active pulmonary tuberculosis infection was detected by medical history or CT examination within 1 year before enrolment;
- Severe infection within 4 weeks before the first dose of medication;
- Have serious cardiovascular and cerebrovascular diseases;
- Patients with clinically significant bleeding symptoms within 3 months before the first study medication;
- Arterial/venous thrombotic events within 6 months before the first dose of study medication;
- Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); A history of hypertensive crisis or hypertensive encephalopathy;
- Refractory nausea, vomiting, chronic gastrointestinal diseases, etc.
- Subjects with active, known or suspected autoimmune disease (including Hiv-Positive), or a history of organ transplantation;
- Presence of active hepatitis B or C;
- A live or attenuated vaccine was administered within 4 weeks before the first dose of the study drug;
- The adverse reactions of antineoplastic therapy have not recovered to NCI-CTCAE v5.0 grade ≤ 1;
- A history of severe allergic reaction with other monoclonal antibodies or have allergic reactions to any component of SHR-A1921 and adbelimumab;
- According to the investigator's judgment, there are other factors that may affect the results of the study or lead to the forced termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental diseases) requiring combined treatment, serious laboratory test abnormalities, accompanied by family or social factors, which will affect the safety of the subjects.
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
Official title: An Exploratory Clinical Study of SHR-A1921 Combined With Adebrelimab in the Treatment of Advanced NSCLC Who Failed the Previous Standard First-line Treatment
This is a Phase II clinical study to evaluate the efficacy and safety of SHR-A1921 conbined with adebrelimab in advanced NSCLC who failed the previous first-line standard therapy. Subjects in this study were treated with SHR-A1921 in combination with adebrelimab until disease progression, intolerable toxicity occurs, informed consent is withdrawn, or other conditions requiring termination of medication, whichever occurred first. The maximum treatment time of adebrelimab is 35 cycles or 2 years (whichever comes first), and subjects can continue to be treated with SHR-A1921 until disease progression, intolerable toxicity occurs, informed consent is withdrawn, or other conditions requiring termination of medication. Primary objective of this study was to evaluate the efficacy of SHR-A1921 combined with adebrelimab in advanced NSCLC who failed the previous first-line standard therapy. Secondary objective of this study was to evaluate the safety of SHR-A1921 combined with adebrelimab in advanced NSCLC who failed the previous first-line standard therapy; Exploratory objective of this study was to evaluate the biomarker changes during treatment with SHR-A1921 combined with adebrelimab in patients with advanced NSCLC who failed the previous first-line standard therapy.
- Conditions
- NSCLC
- Being tested
- SHR-A1921 injection and adebrelimab injection
- Keywords
- Trop-2 ADC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1921 injection and adebrelimab injectionDrug
The Treatment group receive SHR-A1921 injection combined with adebrelimab injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | SHR-A1921+adebrelimab Receives: Drug: SHR-A1921 injection and adebrelimab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Objective response rate represents the proportion of patients showing a predefined level of tumor shrinkage or disappearance in response to treatment.
Measured: Screening up to study completion, an average of 2 year
Secondary outcomes (4)
Progression-free Survival
Progression-free survival measures the length of time during and after treatment that a patient lives with the disease. without it progressing.
Measured: Screening up to study completion, an average of 2 year
Duration of response
Duration of response refers to the length of time during which a patient's tumor remains in remission or shows a positive response to treatment.
Measured: Screening up to study completion, an average of 2 year
Overall Survival
Overall survival measures the length of time from the start of treatment until death from any cause, indicating the effectiveness of the treatment in prolonging patients' lives.
Measured: Screening up to study completion, an average of 2 year
Disease control rate
Disease control rate refers to the proportion of patients whose tumors shrink or stabilize for a certain period of time, including complete response (CR), partial response (PR), and stable disease (SD) cases.
Measured: Screening up to study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start15 Jul 2024 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunxia Su, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480136
- Sponsor's protocol ID
- 2024LY0534
- Status last verified
- Jun 2024
- First submitted
- 25 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Public article
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of SHR-A1921 Combined With Adebrelimab in the Treatment of Advanced NSCLC Who Failed the Previous Standard First-line Treatment
- ClinicalTrials.gov ID
- NCT06480136
- Acronym / sponsor ID
- 2024LY0534
- Conditions
- NSCLC
- Keywords
- Trop-2 ADC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Feb 2028 (estimated)
- First posted
- 28 Jun 2024 (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 is a Phase II clinical study to evaluate the efficacy and safety of SHR-A1921 conbined with adebrelimab in advanced NSCLC who failed the previous first-line standard therapy. Subjects in this study were treated with SHR-A1921 in combination with adebrelimab until disease progression, intolerable toxicity occurs, informed consent is withdrawn, or other conditions requiring termination of medication, whichever occurred first. The maximum treatment time of adebrelimab is 35 cycles or 2 years (whichever comes first), and subjects can continue to be treated with SHR-A1921 until disease progression, intolerable toxicity occurs, informed consent is withdrawn, or other conditions requiring termination of medication. Primary objective of this study was to evaluate the efficacy of SHR-A1921 combined with adebrelimab in advanced NSCLC who failed the previous first-line standard therapy. Secondary objective of this study was to evaluate the safety of SHR-A1921 combined with adebrelimab in advanced NSCLC who failed the previous first-line standard therapy; Exploratory objective of this study was to evaluate the biomarker changes during treatment with SHR-A1921 combined with adebrelimab in patients with advanced NSCLC who failed the previous first-line standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: SHR-A1921 injection and adebrelimab injectionSHR-A1921+adebrelimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Willing to join in this study, signed informed consent, good adherence, can cooperate with the follow-up;
- Age 18-75 years old, both genders;
- Patients with histologically or cytologically confirmed advanced or metastatic NSCLC（Advanced stage is defined as stage IIIb-IV according to the 8th edition of the IASLC TNM staging criteria), and no longer suitable for radical surgery or radiotherapy combined with chemotherapy；
- Participants with nonsquamous tumors were required to have available genetic testing to confirm without EGFR, ALK, or ROS1 driver mutations;
- Disease progression after prior immunization (PD-1/L1 antibody)or combined with platinum-based chemotherapy;
Key exclusion criteria (25 listed)
- Previous receipt of any drug containing a topoisomerase I inhibitor drug, including antibody-drug conjugates;
- Previous receipt of TROP2-targeted therapy;
- Grade 3 or above immune-related adverse events occurred during previous immunotherapy, such as immune-related interstitial lung disease, immune-related myocarditis, immune hepatitis, etc.
- More than 10% of the tumor tissue was histologically or cytologically confirmed as small-cell lung cancer, neuroendocrine carcinoma, carcinosarcoma;
- Untreated brain metastasis, or associated with meningeal metastasis, spinal cord compression, etc. Patients who had received previous treatment for brain metastases (radiotherapy or surgery) were eligible for enrollment if they had been stable for at least 4 weeks as confirmed by imaging and had been free of systemic hormone therapy (at a dose of >10 mg per day of prednisone or the equivalent) for more than 2 weeks and were asymptomatic;
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 |
|---|---|---|
| SHR-A1921 injection and adebrelimab injectionThe Treatment group receive SHR-A1921 injection combined with adebrelimab injection | Drug | Treatment group |
Primary outcome
Objective response rate
Time frame: Screening up to study completion, an average of 2 year
Objective response rate represents the proportion of patients showing a predefined level of tumor shrinkage or disappearance in response to treatment.
4 secondary outcomes
Progression-free Survival
Time frame: Screening up to study completion, an average of 2 year
Duration of response
Time frame: Screening up to study completion, an average of 2 year
Overall Survival
Time frame: Screening up to study completion, an average of 2 year
Disease control rate
Time frame: Screening up to study completion, an average of 2 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 28 Jun 2024.
- Individual participant dataSharing planned: Yes. Public article
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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?
A Phase 2 study testing SHR-A1921 injection and adebrelimab injection in people with NSCLC, run by Shanghai Pulmonary Hospital, Shanghai, 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 15 inclusion and 25 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 28 Jun 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Mengqing Xie, MSc (+86 15925891972, xmqfighting@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: Screening up to study completion, an average of 2 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 28 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.