Advanced Non-small Cell Lung CancerPhase 1/2NCT06434103
Clinical Study of SHR-A1921 Combined With Adebrelimab and SHR-8068 With or Without Carboplatin in the Treatment of Advanced NSCLC
A Phase 1/2 study testing SHR-A1921；Adebrelimab；SHR-8068；carboplatin in people with Advanced Non-small Cell Lung Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd..
Trial summary
A trial to evaluate the tolerability and efficacy of SHR-A1921 in combination with adbelizumab and SHR-8068 with or without carboplatin in patients with advanced non-small cell lung cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Non-small Cell Lung Cancer
- What is being tested?
- SHR-A1921；Adebrelimab；SHR-8068；carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2024to 10 Oct 2024
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteer to join the clinical study, and sign the informed consent, compliance is good, can cooperate with follow-up;
- Aged 18-75 at the time of signing the informed consent;
- Histologically or cytologically confirmed patients with locally advanced or metastatic non-cellular lung cancer who are not eligible for surgical resection or radical concurrent chemoradiotherapy;
- At least one measurable lesion consistent with RECIST v1.1;
- ECOG PS score: 0-1;
- The organ function level is good;
Who cannot join
- Untreated (radiation or surgery) central nervous system metastasis, or accompanied by meningeal metastasis, spinal cord compression, etc.;
- Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion with clinical symptoms;
- Previous or co-existing malignant neoplasms;
- The presence of any active or known autoimmune disease;
- Have clinical symptoms or diseases of the heart that are not well controlled;
- People with past or current interstitial pneumonia/interstitial lung disease;
- Known allergic reactions to any component of SHR-A1921, Adebrelimab, or severe allergic reactions to other monoclonal antibodies;
- Have previously received topoisomerase I inhibitors (including but not limited to irinotecan, Topotecan), TROP-2ADC, or ADC drugs containing topoisomerase I inhibitors; Previously received anti-PD-1 /PD-L1 antibody or anti-CTLA-4 antibody treatment;
About this study
Official title: An Open, Multicenter Phase I/II Trial of SHR-A1921 in Combination With Adebrelimab and SHR-8068 With or Without Carboplatin in the Treatment of Advanced NSCLC
A trial to evaluate the tolerability and efficacy of SHR-A1921 in combination with adbelizumab and SHR-8068 with or without carboplatin in patients with advanced non-small cell lung cancer
- Conditions
- Advanced Non-small Cell Lung Cancer
- Being tested
- SHR-A1921；Adebrelimab；SHR-8068；carboplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1921；Adebrelimab；SHR-8068；carboplatinDrug
SHR-A1921:Specified dose on specified days. SHR-8068: Specified dose on specified days. Adebrelimab: Specified dose on specified days. Carboplatin:Specified dose on specified days.
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1921 combined with Adebrelimab and SHR-8068 with or without carboplatin | Experimental | Not described Receives: Drug: SHR-A1921；Adebrelimab；SHR-8068；carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Measured: 21 days after the first dose
ORR based on RECIST v1.1 assessment.
Measured: All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 2 years
Secondary outcomes (2)
Adverse event
Measured: All informed subjects signed informed consent from the beginning to the end of the safety follow-up period， up to 2 years
DCR based on RECIST v1.1 assessment
Measured: All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start10 Oct 2024
- Primary completion10 Oct 2024
- Study completion10 Oct 2024
Why it stopped: Sponsor's Strategy Adjustment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434103
- Sponsor's protocol ID
- SHR-A1921-205
- Status last verified
- Apr 2026
- First submitted
- 23 May 2024
- Last updated
- 8 Apr 2026
- 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 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multicenter Phase I/II Trial of SHR-A1921 in Combination With Adebrelimab and SHR-8068 With or Without Carboplatin in the Treatment of Advanced NSCLC
- ClinicalTrials.gov ID
- NCT06434103
- Acronym / sponsor ID
- SHR-A1921-205
- Conditions
- Advanced Non-small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor's Strategy Adjustment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 30 May 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.
A trial to evaluate the tolerability and efficacy of SHR-A1921 in combination with adbelizumab and SHR-8068 with or without carboplatin in patients with advanced non-small cell lung cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-A1921 combined with Adebrelimab and SHR-8068 with or without carboplatin | Experimental | Drug: SHR-A1921；Adebrelimab；SHR-8068；carboplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Volunteer to join the clinical study, and sign the informed consent, compliance is good, can cooperate with follow-up;
- Aged 18-75 at the time of signing the informed consent;
- Histologically or cytologically confirmed patients with locally advanced or metastatic non-cellular lung cancer who are not eligible for surgical resection or radical concurrent chemoradiotherapy;
- At least one measurable lesion consistent with RECIST v1.1;
- ECOG PS score: 0-1;
Key exclusion criteria (8 listed)
- Untreated (radiation or surgery) central nervous system metastasis, or accompanied by meningeal metastasis, spinal cord compression, etc.;
- Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion with clinical symptoms;
- Previous or co-existing malignant neoplasms;
- The presence of any active or known autoimmune disease;
- Have clinical symptoms or diseases of the heart that are not well controlled;
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；Adebrelimab；SHR-8068；carboplatinSHR-A1921:Specified dose on specified days. SHR-8068: Specified dose on specified days. Adebrelimab: Specified dose on specified days. Carboplatin:Specified dose on specified days. | Drug | SHR-A1921 combined with Adebrelimab and SHR-8068 with or without carboplatin |
Primary outcome
DLT
Time frame: 21 days after the first dose
ORR based on RECIST v1.1 assessment.
Time frame: All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 2 years
2 secondary outcomes
Adverse event
Time frame: All informed subjects signed informed consent from the beginning to the end of the safety follow-up period， up to 2 years
DCR based on RECIST v1.1 assessment
Time frame: All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Advanced Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
RecruitingPhase 3
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer
RecruitingPhase 2
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SHR-A1921；Adebrelimab；SHR-8068；carboplatin in people with Advanced Non-small Cell Lung Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd..
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 6 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: withdrawn, as of the sponsor's last update on 8 Apr 2026. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
DLT (time frame: 21 days after the first dose). The study lists 2 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 8 Apr 2026.