NSCLCPhase 2NCT06465238
Clinical Study of SHR-A1921 or SHR-A2009 in Previously Treated Advanced NSCLC
A Phase 2 study testing SHR-A2009 and SHR-A1921 in people with NSCLC, run by Henan Cancer Hospital at 1 site in China.
Trial summary
This study is an open-label Phase II clinical trial to evaluate the safety and efficacy of SHR-A1921 or SHR-A2009 in patients with advanced NSCLC who progressed after 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-A2009 and SHR-A1921
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jun 2024to Jun 2027
- 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
- Voluntary participation and written informed consent;
- Aged 18-75 years (inclusive), males and females;
- Has a histologically or cytologically confirmed diagnosis of metastatic NSCLC (according to 8th AJCC/UICC Classification);
- Has failed to standard therapy and disease progressed after antibody-conjugated drugs therapy;
- Has at least 1 measurable lesion per RECIST 1.1;
- Patients with ECOG score of 0-1;
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- Life expectancy ≥12 weeks;
- Have adequate organ function;
- Participants agrees to use contraception, and be abstinent from heterosexual intercourse during the treatment period and for ≥180 days after the last dose of study treatment.
Who cannot join
- Histologically or cytologically confirmed presence of small-cell lung cancer or other benefit-limiting tumor components;
- Untreated brain metastasis or accompanied by meningeal metastases, spinal cord compression;
- Cancerous ascites, pleural effusion or pericardial effusion with clinical symptoms;
- Subjects who have received systemic anti-tumor treatments prior to the initiation of the study treatment;
- Has received major organ surgery or high-intensity thoracic radiotherapy within before first dose of study therapy；
- Has a history of a second malignancy;
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- Has a history of non-infectious ILD/pneumonitis that required steroids, or has current ILD/pneumonitis;
- Subjects with active pulmonary tuberculosis infection；
- Serious infection before the first dose；
- Uncontrolled cardiac diseases or symptoms;
- Arterial/venous thrombosis events occurred before the first dose；
- Hypertension that can not be well controlled through antihypertensive drugs，previous hypertensive crisis or hypertensive encephalopathy；
- Has a history of active chronic enteritis;
- Has a history of bleeding prior to the initiation of the study treatment;
- History of immunodeficiency disease or organ transplant;
- Subjects with active hepatitis B or active hepatitis C;
- Has unresolved toxicities from previous anticancer therapy;
- Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A1921or SHR-A2009;
- Subjects with other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of the patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase II Study of the Efficacy and Safety of SHR-A1921 or SHR-A2009 in Patients With Previously Treated Advanced NSCLC
This study is an open-label Phase II clinical trial to evaluate the safety and efficacy of SHR-A1921 or SHR-A2009 in patients with advanced NSCLC who progressed after standard therapy.
- Conditions
- NSCLC
- Being tested
- SHR-A2009, SHR-A1921
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A2009Drug
Treatment group: Subjects will receive an intravenous infusion of SHR-A2009 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.
SHR-A1921Drug
Treatment group: Subjects will receive an intravenous infusion of SHR-A1921 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group 1 | Experimental | SHR-A2009 Receives: Drug: SHR-A2009 |
| Treatment group 2 | Experimental | SHR-A1921 Receives: Drug: SHR-A1921 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Assessed by Investigator According to RECIST v1.1
Measured: up to 12 months
Secondary outcomes (6)
Progression-free survival (PFS)
Assessed by Investigator According to RECIST v1.1
Measured: up to 12 months
overall survival (OS)
OS is the time from the date of first dose until the date of death by any cause.
Measured: up to 24 months
Duration of response(DoR )
Assessed by Investigator According to RECIST v1.1
Measured: up to 12 months
Disease control rate (DCR)
Assessed by Investigator According to RECIST v1.1
Measured: up to 12 months
Time to Response (TTR)
Assessed by Investigator According to RECIST v1.1
Measured: up to 12 months
The incidence and severity of adverse events (AEs)
Rated based on CTCAE V5.0
Measured: from Day1 to 90 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (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 Henan Cancer HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Qiming Wang, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465238
- Sponsor's protocol ID
- NSCLC-IIT-SHRA2009-SHRA1921
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 20 Jun 2024
- 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 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of the Efficacy and Safety of SHR-A1921 or SHR-A2009 in Patients With Previously Treated Advanced NSCLC
- ClinicalTrials.gov ID
- NCT06465238
- Acronym / sponsor ID
- NSCLC-IIT-SHRA2009-SHRA1921
- Conditions
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 18 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 study is an open-label Phase II clinical trial to evaluate the safety and efficacy of SHR-A1921 or SHR-A2009 in patients with advanced NSCLC who progressed after standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group 1 | Experimental | Drug: SHR-A2009SHR-A2009 |
| Treatment group 2 | Experimental | Drug: SHR-A1921SHR-A1921 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntary participation and written informed consent;
- Aged 18-75 years (inclusive), males and females;
- Has a histologically or cytologically confirmed diagnosis of metastatic NSCLC (according to 8th AJCC/UICC Classification);
- Has failed to standard therapy and disease progressed after antibody-conjugated drugs therapy;
- Has at least 1 measurable lesion per RECIST 1.1;
Key exclusion criteria (19 listed)
- Histologically or cytologically confirmed presence of small-cell lung cancer or other benefit-limiting tumor components;
- Untreated brain metastasis or accompanied by meningeal metastases, spinal cord compression;
- Cancerous ascites, pleural effusion or pericardial effusion with clinical symptoms;
- Subjects who have received systemic anti-tumor treatments prior to the initiation of the study treatment;
- Has received major organ surgery or high-intensity thoracic radiotherapy within before first dose of study therapy；
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-A2009Treatment group: Subjects will receive an intravenous infusion of SHR-A2009 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study. | Drug | Treatment group 1 |
| SHR-A1921Treatment group: Subjects will receive an intravenous infusion of SHR-A1921 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study. | Drug | Treatment group 2 |
Primary outcome
Overall response rate (ORR)
Time frame: up to 12 months
Assessed by Investigator According to RECIST v1.1
6 secondary outcomes
Progression-free survival (PFS)
Time frame: up to 12 months
overall survival (OS)
Time frame: up to 24 months
Duration of response(DoR )
Time frame: up to 12 months
Disease control rate (DCR)
Time frame: up to 12 months
Time to Response (TTR)
Time frame: up to 12 months
The incidence and severity of adverse events (AEs)
Time frame: from Day1 to 90 days after last dose
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 Jun 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-A2009 and SHR-A1921 in people with NSCLC, run by Henan Cancer Hospital 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 19 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 20 Jun 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.
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 Qiming Wang, professor (13783590691, qimingwang1006@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: up to 12 months). 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 Jun 2024.