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Non-small Cell Lung CancerPhase 2NCT07863167

An Open, Multicenter Phase II Clinical Trial of SHR-A2009 Combined With Other Anti-tumor Therapies for Perioperative Treatment of Resectable Non-small Cell Lung Cancer.

A Phase 2 study testing adebrelimab + SHR-A2009, paclitaxel or pemetrexed combined with carboplatin +adebrelimab and adebrelimab in people with Non-small Cell Lung Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The study is being conducted to evaluate the efficacy, and safety of SHR-A2009 combined with other anti-tumor therapies for perioperative treatment of resectable non-small cell lung cancer in adults. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
adebrelimab + SHR-A2009, paclitaxel or pemetrexed combined with carboplatin +adebrelimab and adebrelimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
660 participants
Where
1 siteChina
Study dates
30 Oct 2026to 30 Dec 2030
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 70 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 ;
  • At the time of signing the informed consent form, the age is 18-70 years old ( including both ends ), both men and women can.
  • The ECOG score was 0 or 1.
  • Pathologically confirmed NSCLC, assessed as resectable or previously resected (R0).
  • Adequate bone marrow and organ function.

Who cannot join

  • Participants who received systemic immunostimulatory therapy within 4 weeks prior to the first dose.
  • Participants who received systemic immunosuppressive therapy within 2 weeks before the first dose.
  • Participants with active, known or suspected autoimmune diseases.
  • Other malignant tumors within 5 years before screening.
  • Participants with a history of interstitial pneumonia or cannot exclude interstitial pneumonia; or there are other moderate to severe lung diseases that may affect respiratory function. Or received previous pneumonectomy surgery.
  • Participants with severe cardiovascular and cerebrovascular diseases.
Show all 13Show fewer
  • There were clinically significant bleeding symptoms or obvious bleeding tendency within 1 month before the first administration.
  • Arterial and venous thrombosis events occurred within 3 months before the first administration.
  • HIV test positive.
  • Participants with active hepatitis B or C.
  • 1.Evidence of active tuberculosis infection within 1 year before the first administration.
  • 12.Severe infection occurred within 4 weeks before the first administration. 13.History of severe allergic reactions to other monoclonal antibody / fusion protein drugs.
  • 14. Allergy to any component of the treatment regimen. 15.Participants were known to have a history of psychotropic drug abuse, alcohol abuse or drug abuse.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yijing Chen contact

18810456365

yijing.chen.yc510@hengrui.com

China1 site

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

    Yilong Wu

Other trials in China

About this study

The study is being conducted to evaluate the efficacy, and safety of SHR-A2009 combined with other anti-tumor therapies for perioperative treatment of resectable non-small cell lung cancer in adults.

Being tested
adebrelimab + SHR-A2009, paclitaxel or pemetrexed combined with carboplatin +adebrelimab, adebrelimab, adebeliizumab + SHR-A2009, adebeliizumab + platinum-containing double chemotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • adebrelimab + SHR-A2009Drug

    adebrelimab + SHR-A2009

  • paclitaxel or pemetrexed combined with carboplatin +adebrelimabDrug

    paclitaxel or pemetrexed combined with carboplatin +adebrelimab

  • adebrelimab + SHR-A2009Drug

    adebrelimab + SHR-A2009 (longer-interval regimen arm)

  • adebrelimab + SHR-A2009Drug

    adebrelimab + SHR-A2009 (shorter-interval regimen arm)

  • adebrelimabDrug

    adebrelimab

  • adebeliizumab + SHR-A2009Drug

    adebeliizumab + SHR-A2009 (longer-interval regimen arm)

  • adebeliizumab + SHR-A2009Drug

    adebeliizumab + SHR-A2009 (shorter-interval regimen arm)

  • adebeliizumab + platinum-containing double chemotherapyDrug

    adebeliizumab + platinum-containing double chemotherapy

  • almonertinib combined with SHR-A2009Drug

    almonertinib combined with SHR-A2009 (longer-interval regimen arm)

  • almonertinib combined with SHR-A2009Drug

    almonertinib combined with SHR-A2009 (shorter-interval regimen arm)

  • almonertinibDrug

    almonertinib

  • SHR-A2009 combined with almonertinibDrug

    SHR-A2009 combined with almonertinib

  • almonertinib monotherapyDrug

    almonertinib monotherapy

Study groups in NCT07863167
Study groupRoleWhat they receive
group A1-1adebrelimab + SHR-A2009ExperimentalNot described
Receives: Drug: adebrelimab + SHR-A2009
group A1-2 paclitaxel or pemetrexed combined with carboplatin +adebrelimabActive comparatorNot described
Receives: Drug: paclitaxel or pemetrexed combined with carboplatin +adebrelimab
group1 A2-1adebrelimab + SHR-A2009 (longer-interval regimen arm)ExperimentalNot described
Receives: Drug: adebrelimab + SHR-A2009
group2 A2-2adebrelimab + SHR-A2009 (shorter-interval regimen arm)ExperimentalNot described
Receives: Drug: adebrelimab + SHR-A2009
group A2-3 adebrelimabActive comparatorNot described
Receives: Drug: adebrelimab
group1 A3-1 adebeliizumab + SHR-A2009 (longer-interval regimen arm)ExperimentalNot described
Receives: Drug: adebeliizumab + SHR-A2009
group2 A3-2 adebeliizumab + SHR-A2009 (shorter-interval regimen arm)ExperimentalNot described
Receives: Drug: adebeliizumab + SHR-A2009
group A3-3 adebeliizumab + platinum-containing double chemotherapyActive comparatorNot described
Receives: Drug: adebeliizumab + platinum-containing double chemotherapy
group B1-1 almonertinib combined with SHR-A2009 (longer-interval regimen arm)ExperimentalNot described
Receives: Drug: almonertinib combined with SHR-A2009
group B1-2 almonertinib combined with SHR-A2009 (shorter-interval regimen arm)ExperimentalNot described
Receives: Drug: almonertinib combined with SHR-A2009
group B1-3 almonertinibActive comparatorNot described
Receives: Drug: almonertinib
group B2-1 SHR-A2009 combined with almonertinibExperimentalNot described
Receives: Drug: SHR-A2009 combined with almonertinib
group B2-2 almonertinib monotherapyActive comparatorNot described
Receives: Drug: almonertinib monotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A1 : pCR rate;

    Measured: about 24 months

  2. Part A2 : 2-year DFS rate;

    Measured: about 24 months

  3. Part A3 : pCR rate and 18-month EFS rate;

    Measured: about 18 months

  4. Part B1 : 2-year DFS rate.

    Measured: about 24 months

  5. Part B2 : MPR rate.

    Measured: about 24 months

Secondary outcomes (6)

  1. The incidence and grade of adverse events;

    Measured: about 48 months

  2. surgical complications;

    Measured: about 24 months

  3. EFS

    Measured: about 24 months ;

  4. ORR;

    Measured: about 24 months

  5. DFS and DFS rates;

    Measured: about 24 months

  6. OS ;

    Measured: about 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2026
  2. Study start30 Oct 2026 (estimated)
  3. Primary completion30 Dec 2028 (estimated)
  4. Study completion30 Dec 2030 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
This is a parallel-arm study in which participants are categorized by biomarker profile and treatment stage. Within each cohort, randomization will be applied to determine treatment assignment.
Masking
None (open label)
Enrolment
660 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07863167
Sponsor's protocol ID
SHR-A2009-203
Status last verified
Sep 2026
First submitted
30 Sep 2026
Last updated
7 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing adebrelimab + SHR-A2009, paclitaxel or pemetrexed combined with carboplatin +adebrelimab and adebrelimab in people with 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 5 inclusion and 13 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 7 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 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 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?

Part A1 : pCR rate; (time frame: about 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07863167.

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 7 Oct 2026.

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