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Non-small Cell Lung Cancer (NSCLC)Phase 3NCT07895238

A Study of Perioperative Adebrelimab Plus Chemotherapy Versus Adjuvant Therapy in Patients With Resectable NSCLC

A Phase 3 study testing Adebrelimab (SHR-1316) + chemotherapy and Adebrelimab in people with Non-small Cell Lung Cancer (NSCLC), run by West China Hospital.

Not yet recruiting

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

Official record
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Trial summary

This is a randomized, multicenter, phase III clinical study to compare the efficacy and safety of perioperative treatment with adebrelimab plus platinum-based chemotherapy versus adebrelimab adjuvant therapy in patients with resectable stage II-IIIB non-small-cell lung cancer(NSCLC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer (NSCLC)
What is being tested?
Adebrelimab (SHR-1316) + chemotherapy and Adebrelimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,088 participants
Where
No sites listed yet
Study dates
31 Oct 2026to 31 Dec 2034
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily participate in this clinical study, understand study procedures, and be capable of providing written informed consent.
  • Aged ≥18 years at the time of informed consent signature; both male and female subjects are eligible.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Histologically or cytologically confirmed Stage II-III non small cell lung cancer (NSCLC) deemed by the investigator amenable to curative intent R0 surgical resection. Disease staging shall be performed per the American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) 9th edition NSCLC staging system.
  • Availability of sufficient tumor tissue specimens.
  • Have measurable target lesions assessed by computed tomography (CT) or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
  • Adequate hematologic and end organ function.
  • Female subjects of child bearing potential who have not undergone surgical sterilization, and male subjects, must agree to use at least one medically accepted contraceptive method during study treatment and for 180 days after the end of study treatment. For non surgically sterilized female subjects of child bearing potential, serum human chorionic gonadotropin (HCG) test must be negative within 14 days prior to the first study drug administration.

Who cannot join

  • Histologically or cytologically confirmed mixed small cell lung cancer (SCLC) and non small cell lung cancer (NSCLC), large cell neuroendocrine carcinoma, or sarcomatoid carcinoma.
  • Subjects with non squamous NSCLC histology harboring positive epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) positivity.
  • Presence of uncontrolled third space effusions, e.g., substantial pleural effusion, ascites, or pericardial effusion.
  • Prior receipt of any anti neoplastic therapy, including but not limited to radiotherapy, chemotherapy, targeted therapy, immunotherapy, antibody drug conjugates (ADCs), etc.
  • Participation in another clinical study within 4 weeks or 5 half lives of the investigational product (whichever is shorter) prior to the first study drug administration.
  • Receipt of systemic immunosuppressive therapy within 2 weeks before the first study drug administration.
Show all 21Show fewer
  • Congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection.
  • Active hepatitis B (HBV DNA ≥ 1000 IU/mL), hepatitis C (positive hepatitis C antibody with HCV RNA above the lower limit of quantification of the assay), or co infection with both HBV and HCV.
  • Presence of autoimmune disease. The following conditions are permitted: type 1 diabetes mellitus with glycemic control achievable via insulin therapy; hypothyroidism secondary to autoimmune thyroiditis requiring only hormone replacement therapy; vitiligo limited to cutaneous manifestations (psoriatic arthritis must be excluded).
  • History of other malignancies (other than NSCLC) within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin carcinoma, radically resected localized prostate cancer, and radically resected ductal carcinoma in situ (hormonal therapy for non metastatic prostate or breast cancer is permitted).
  • Subjects with prior history of interstitial pneumonia requiring corticosteroid therapy.
  • Subjects with severe cardiovascular or cerebrovascular diseases, including arrhythmias judged by the investigator to be clinically significant and markedly abnormal rendering the subject ineligible for trial enrollment.
  • Severe infection occurring within 4 weeks before the first study drug administration; evidence of active tuberculosis infection within 1 year prior to first study drug administration.
  • Subjects with prior or planned allogeneic bone marrow transplantation or solid organ transplantation.
  • History of live attenuated vaccine administration within 28 days before the first study drug administration, or planned administration of live attenuated vaccines during the study period.
  • Arterial or venous thromboembolic events occurring within 3 months.
  • Clinically significant bleeding episodes or evident bleeding diathesis within 1 month prior to the first study drug administration.
  • Pregnant or lactating women; subjects of child bearing potential who are unwilling or unable to implement effective contraceptive measures.
  • Known allergy, hypersensitivity, or intolerance to adebrelimab, chemotherapeutic agents, or their excipients.
  • Known history of psychotropic substance abuse, alcoholism, or illicit drug use.
  • Any condition that, in the investigator's opinion, may jeopardize the subject or prevent the subject from meeting or complying with study requirements.

About this study

Official title: An Open-Label, Randomized Controlled Clinical Trial of Perioperative Adebrelimab Plus Chemotherapy Versus Adjuvant Therapy in Patients With Resectable Non-Small Cell Lung Cancer

This is a randomized, multicenter, phase III clinical study to compare the efficacy and safety of perioperative treatment with adebrelimab plus platinum-based chemotherapy versus adebrelimab adjuvant therapy in patients with resectable stage II-IIIB non-small-cell lung cancer(NSCLC).

Being tested
Adebrelimab (SHR-1316) + chemotherapy, Adebrelimab
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-1316) + chemotherapyDrug

    3 cycles of adebrelimab 1200 mg plus platinum-containing doublet chemotherapy administered every 3 weeks (Q3W); followed by postoperative adjuvant adebrelimab 1200 mg

  • AdebrelimabDrug

    Patients who have undergone curative-intent surgery receive adjuvant chemotherapy, followed by adebrelimab 1200 mg

Study groups in NCT07895238
Study groupRoleWhat they receive
Treatment group AExperimentalNeoadjuvant adebrelimab plus chemotherapy followed by surgery, then adjuvant adebrelimab after surgery.
Receives: Drug: Adebrelimab (SHR-1316) + chemotherapy
Treatment group BExperimentalAdjuvant adebrelimab therapy
Receives: Drug: Adebrelimab

What is being measured

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

  1. EFS

    Event free survival

    Measured: Approximately 96 months

Secondary outcomes (7)

  1. OS

    Overall survival

    Measured: Approximately 96 months

  2. R0 resection rate

    Measured: At time of surgery

  3. MPR

    Major pathological response rate

    Measured: At time of surgery

  4. pCR

    Pathology complete response

    Measured: At time of surgery

  5. ORR

    Objective response rate

    Measured: Prior to surgery

  6. DFS

    Disease-Free Survival

    Measured: Approximately 96 months

  7. AE

    Adverse events

    Measured: Approximately 96 months

Timeline

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

  1. First posted26 Oct 2026
  2. Study start31 Oct 2026 (estimated)
  3. Primary completion31 Dec 2032 (estimated)
  4. Study completion31 Dec 2034 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,088 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07895238
Sponsor's protocol ID
MA-NSCLC-III-069
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
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adebrelimab (SHR-1316) + chemotherapy and Adebrelimab in people with Non-small Cell Lung Cancer (NSCLC), run by West China Hospital.

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 8 inclusion and 21 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.

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?

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?

EFS (time frame: Approximately 96 months). 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 NCT07895238.

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.

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