Non-squamous Non-small Cell Lung CancerPhase 3NCT07895992
SHR-A2009 Combined With Bevacizumab in the Treatment of Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer : a Randomized Controlled, Open, Multicenter Phase III Study
A Phase 3 study testing SHR-A2009 + bevacizumab and Sacituzumab Tirumotecan in people with Non-squamous Non-small Cell Lung Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy, and safety of SHR-A2009 combined bevacizumab versus Sacituzumab Tirumotecan in the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-squamous Non-small Cell Lung Cancer
- What is being tested?
- SHR-A2009 + bevacizumab and Sacituzumab Tirumotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 490 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2026to 30 Dec 2030
- Phase
- Phase 3
- 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
- voluntarily participate in this clinical study, understand the research procedure and be able to sign the informed consent in writing ; the age at the time of signing the informed consent form is 18-75 years old ( including both ends ), both men and women can.
- The ECOG score was 0 or 1.
- Participants with locally advanced or metastatic non-squamous non-small cell lung cancer confirmed by histology or cytology.
- Adequate bone marrow and organ function.
Who cannot join
- Anti-tumor therapy such as chemotherapy, biological therapy, targeted therapy, immunotherapy or other unlisted clinical research drugs or treatments were received within 4 weeks before the first medication.
- Untreated or active central nervous system tumor metastasis
- Imaging showed that the tumor invaded important organs or tumor surrounding / invasion of large blood vessels or there was obvious necrosis / cavity, which was judged by the researchers to have a risk of bleeding.
- History of interstitial pneumonia or participants who cannot rule out interstitial pneumonia ; or other moderate to severe lung diseases ; or received previous pneumonectomy surgery
- Participants with severe cardiovascular and cerebrovascular diseases
- Have a history of severe bleeding tendency or coagulation dysfunction ; bleeding symptoms with significant clinical significance occurred within 3 months before the first medication.
Show all 11Show fewer
- Arterial and venous thrombosis events occurred within 6 months before the first administration ;
- HIV test positive
- Participants with active hepatitis B or C
- Severe infection occurred within 4 weeks before the first administration
- Allergy to any component of the treatment regimen
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
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Yilong Wu
About this study
Official title: A Randomized, Open-label, Multicenter, Phase III Study of SHR-A2009 in Combination With Bevacizumab Versus Sacituzumab Tirumotecan in Advanced or Metastatic Non-small Cell Lung Cancer
The study is being conducted to evaluate the efficacy, and safety of SHR-A2009 combined bevacizumab versus Sacituzumab Tirumotecan in the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Being tested
- SHR-A2009 + bevacizumab, Sacituzumab Tirumotecan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A2009 + bevacizumabDrug
SHR-A2009 + bevacizumab
Sacituzumab TirumotecanDrug
Sacituzumab Tirumotecan
| Study group | Role | What they receive |
|---|---|---|
| SHR-A2009 + bevacizumab | Experimental | Not described Receives: Drug: SHR-A2009 + bevacizumab |
| Sacituzumab Tirumotecan | Active comparator | Not described Receives: Drug: Sacituzumab Tirumotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Measured: about 24 months
Secondary outcomes (5)
The incidence and grade of adverse events;
Measured: about 24 months
OS
Measured: about 24 months
ORR
Measured: about 24 months
DoR
Measured: about 24 months
DCR
Measured: about 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-squamous 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a randomized controlled, open, multicenter phase III study.
- Masking
- None (open label)
- Enrolment
- 490 participants (estimated)
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
- NCT07895992
- Sponsor's protocol ID
- SHR-A2009-303
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multicenter, Phase III Study of SHR-A2009 in Combination With Bevacizumab Versus Sacituzumab Tirumotecan in Advanced or Metastatic Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07895992
- Acronym / sponsor ID
- SHR-A2009-303
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 26 Oct 2026 (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 study is being conducted to evaluate the efficacy, and safety of SHR-A2009 combined bevacizumab versus Sacituzumab Tirumotecan in the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a randomized controlled, open, multicenter phase III study.
| Arm | Type | Receives |
|---|---|---|
| SHR-A2009 + bevacizumab | Experimental | Drug: SHR-A2009 + bevacizumab |
| Sacituzumab Tirumotecan | Active comparator | Drug: Sacituzumab Tirumotecan |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- voluntarily participate in this clinical study, understand the research procedure and be able to sign the informed consent in writing ; the age at the time of signing the informed consent form is 18-75 years old ( including both ends ), both men and women can.
- The ECOG score was 0 or 1.
- Participants with locally advanced or metastatic non-squamous non-small cell lung cancer confirmed by histology or cytology.
- Adequate bone marrow and organ function.
Key exclusion criteria (11 listed)
- Anti-tumor therapy such as chemotherapy, biological therapy, targeted therapy, immunotherapy or other unlisted clinical research drugs or treatments were received within 4 weeks before the first medication.
- Untreated or active central nervous system tumor metastasis
- Imaging showed that the tumor invaded important organs or tumor surrounding / invasion of large blood vessels or there was obvious necrosis / cavity, which was judged by the researchers to have a risk of bleeding.
- History of interstitial pneumonia or participants who cannot rule out interstitial pneumonia ; or other moderate to severe lung diseases ; or received previous pneumonectomy surgery
- Participants with severe cardiovascular and cerebrovascular diseases
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-A2009 + bevacizumabSHR-A2009 + bevacizumab | Drug | SHR-A2009 + bevacizumab |
| Sacituzumab TirumotecanSacituzumab Tirumotecan | Drug | Sacituzumab Tirumotecan |
Primary outcome
PFS
Time frame: about 24 months
5 secondary outcomes
The incidence and grade of adverse events;
Time frame: about 24 months
OS
Time frame: about 24 months
ORR
Time frame: about 24 months
DoR
Time frame: about 24 months
DCR
Time frame: about 24 months
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 26 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHR-A2009 + bevacizumab and Sacituzumab Tirumotecan in people with Non-squamous Non-small Cell Lung Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. 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 4 inclusion and 11 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 26 Oct 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yijing Chen (18810456365, yijing.chen.yc510@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: about 24 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 26 Oct 2026.