ClinicalTrials.gg
Not yet recruitingNCT07895238Updated Oct 26, 2026

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

A Phase 3 interventional study of Adebrelimab (SHR-1316) + chemotherapy and Adebrelimab in Non-small Cell Lung Cancer (NSCLC), sponsored by West China Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by West China Hospital · Phase 3, Interventional, and Treatment

Updated Oct 26, 2026Newly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
1,088
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Non-small Cell Lung Cancer (NSCLC)
03

In context

Carcinoma, Non-Small-Cell Lung

6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.

This study's planned enrollment of 1,088 is above the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

West China Hospital is the lead sponsor of 498 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Voluntarily participate in this clinical study, understand study procedures, and be capable of providing written informed consent.
  2. Aged ≥18 years at the time of informed consent signature; both male and female subjects are eligible.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  4. 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.
  5. Availability of sufficient tumor tissue specimens.
  6. 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).
  7. Adequate hematologic and end organ function.
  8. 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.

Exclusion criteria

Exclusion Criteria:

  1. Histologically or cytologically confirmed mixed small cell lung cancer (SCLC) and non small cell lung cancer (NSCLC), large cell neuroendocrine carcinoma, or sarcomatoid carcinoma.
  2. Subjects with non squamous NSCLC histology harboring positive epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) positivity.
  3. Presence of uncontrolled third space effusions, e.g., substantial pleural effusion, ascites, or pericardial effusion.
  4. Prior receipt of any anti neoplastic therapy, including but not limited to radiotherapy, chemotherapy, targeted therapy, immunotherapy, antibody drug conjugates (ADCs), etc.
  5. 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.
  6. Receipt of systemic immunosuppressive therapy within 2 weeks before the first study drug administration.
  7. Congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection.
  8. 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.
  9. 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).
  10. 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).
  11. Subjects with prior history of interstitial pneumonia requiring corticosteroid therapy.
  12. 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.
  13. 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.
  14. Subjects with prior or planned allogeneic bone marrow transplantation or solid organ transplantation.
  15. 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.
  16. Arterial or venous thromboembolic events occurring within 3 months.
  17. Clinically significant bleeding episodes or evident bleeding diathesis within 1 month prior to the first study drug administration.
  18. Pregnant or lactating women; subjects of child bearing potential who are unwilling or unable to implement effective contraceptive measures.
  19. Known allergy, hypersensitivity, or intolerance to adebrelimab, chemotherapeutic agents, or their excipients.
  20. Known history of psychotropic substance abuse, alcoholism, or illicit drug use.
  21. Any condition that, in the investigator's opinion, may jeopardize the subject or prevent the subject from meeting or complying with study requirements.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,088 participants (estimated)

Study arms

  • Experimental
    Treatment group A

    Neoadjuvant adebrelimab plus chemotherapy followed by surgery, then adjuvant adebrelimab after surgery.

    Drug: Adebrelimab (SHR-1316) + chemotherapy

  • Experimental
    Treatment group B

    Adjuvant adebrelimab therapy

    Drug: Adebrelimab

Interventions

  • DrugAdebrelimab (SHR-1316) + chemotherapy

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

  • DrugAdebrelimab

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

06

What researchers measure

Primary outcomes

  1. EFS

    Event free survival

    Time frame: Approximately 96 months

Secondary outcomes

  1. OS

    Overall survival

    Time frame: Approximately 96 months

  2. R0 resection rate

    Time frame: At time of surgery

  3. MPR

    Major pathological response rate

    Time frame: At time of surgery

  4. pCR

    Pathology complete response

    Time frame: At time of surgery

  5. ORR

    Objective response rate

    Time frame: Prior to surgery

  6. DFS

    Disease-Free Survival

    Time frame: Approximately 96 months

  7. AE

    Adverse events

    Time frame: Approximately 96 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Dec 2032, 74 months later.

Of 96 non-industry phase 3 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 54 and three quarters within 129. This study's planned 74 months is close to that.

Counting every sponsor, half of 396 studies reached it within 44 months; a quarter within 30 and three quarters within 67.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2026
First posted
Oct 26, 2026
StartEst.
Oct 31, 2026
Primary completionEst.
Dec 31, 2032
CompletionEst.
Dec 31, 2034
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07895238
Responsible party
Zhou Qinghua (Chief Physician, West China Hospital) — Principal investigator
First posted
Oct 26, 2026
Start date
Oct 31, 2026 (estimated)
Primary completion
Dec 31, 2032 (estimated)
Completion
Dec 31, 2034 (estimated)
Last update
Oct 26, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion