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Not yet recruitingNCT07567326Updated May 5, 2026

Adebrelimab or Retlirafusp Alfa Plus Recaticimab and Chemotherapy for Resectable NSCLC

A Phase 2 interventional study of Adebrelimab, Retlirafusp alfa, Recaticimab and chemotherapy in Non Small Cell Lung Cancer, sponsored by Peking University Cancer Hospital & Institute. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by Peking University Cancer Hospital & Institute · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study summary

Although phase III studies have confirmed the efficacy and safety of perioperative immunotherapy plus chemotherapy for resectable NSCLC, there remains room for improvement in both short-term efficacy and long-term survival. Preclinical evidence suggests that PCSK-9 inhibition may synergize with PD-1 inhibitors to suppress tumor growth in mouse models. To date, no data are available on neoadjuvant PCSK-9 inhibitor therapy combined with immunotherapy and chemotherapy in resectable NSCLC. Therefore, this phase II study aims to evaluate the efficacy and safety of neoadjuvant adebrelimab or retlirafusp alfa (SHR-1701) plus recaticimab and chemotherapy in patients with resectable NSCLC.

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Conditions studied

  • Non Small Cell Lung Cancer
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In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 78 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Peking University Cancer Hospital & Institute is the lead sponsor of 261 studies on the registry; 128 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18-75 years old
  • Histologically or cytologically confirmed resectable stage II, IIIA, or selected IIIB (T2-3N2bM0 only) non-small cell lung cancer (NSCLC) according to the International Union Against Cancer (UICC) and American Joint Committee on Cancer (AJCC) 9th edition TNM classification for lung cancer, with the tumor judged by the investigator as amenable to curative-intent R0 resection.
  • Ability to provide tumor tissue specimens, either archived or freshly obtained prior to the first dose of study drug.
  • Presence of measurable target lesions by computed tomography (CT) or magnetic resonance imaging (MRI) according to RECIST version 1.1. Tumor imaging assessment must be performed within 28 days before the first dose.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • No prior anti-cancer therapy, including radiotherapy, chemotherapy, surgery, or targeted therapy, before study enrollment.
  • Adequate hematologic and end-organ function.

Exclusion criteria

Exclusion Criteria:

  • Histologically or cytologically confirmed small cell lung cancer (SCLC), mixed SCLC and NSCLC, or other non-NSCLC pathological types.
  • Known EGFR mutations or ALK positivity, or other actionable driver gene mutations for which approved targeted therapies are available and accessible.
  • Presence of malignant pleural effusion. For subjects with drainable pleural effusion during the screening period, at least one thoracentesis is required to rule out the presence of malignant cells.
  • Prior systemic anti-cancer therapy for non-small cell lung cancer. If the subject has previously received anti-cancer treatment with traditional Chinese medicine (TCM), enrollment is permitted only if the interval between the completion of TCM therapy and the first dose of study drug is at least 2 weeks.
  • Receipt of systemic immunosuppressive therapy within 2 weeks prior to the first dose, or expected need for systemic immunosuppressive medication during the study treatment period.
  • Current participation in an interventional clinical study treatment, or receipt of another investigational drug or investigational device within 4 weeks prior to the first dose.
  • History of malignancies other than NSCLC within 5 years prior to enrollment.
  • Presence of autoimmune disease.
  • Subjects with known or suspected interstitial lung disease; other moderate to severe pulmonary diseases that may interfere with the detection or management of drug-related pulmonary toxicity or significantly impair respiratory function, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia/obstructive bronchiolitis, etc.
  • Subjects with severe cardiovascular or cerebrovascular diseases. Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose.
  • Arterial or venous thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism) within 3 months prior to the first dose.
  • Congenital or acquired immunodeficiency, including but not limited to human immunodeficiency virus (HIV) infection, active hepatitis B, or hepatitis C.
  • Evidence of active tuberculosis infection within 1 year prior to the first dose.
  • Severe infection within 4 weeks prior to the first dose.
  • Receipt of live attenuated vaccine within 28 days prior to the first dose, or planned receipt of live attenuated vaccine during the study period.
  • Major surgery (other than diagnostic procedures or biopsy) within 28 days prior to the first dose.
  • History of or planned allogeneic bone marrow transplantation or solid organ transplantation.
  • History of severe hypersensitivity reactions to other monoclonal antibodies or fusion proteins, or known allergy to any component of the randomly assigned treatment regimen.
  • Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period.
  • Known history of substance abuse, alcohol abuse, or drug addiction.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
78 participants (estimated)

Study arms

  • Experimental
    Arm A

    Adebrelimab plus recaticimab and chemotherapy

    Drug: Adebrelimab, Retlirafusp alfa, Recaticimab and chemotherapy

  • Experimental
    Arm B

    Retlirafusp alfa plus recaticimab and chemotherapy

    Drug: Adebrelimab, Retlirafusp alfa, Recaticimab and chemotherapy

Interventions

  • DrugAdebrelimab, Retlirafusp alfa, Recaticimab and chemotherapy

    Adebrelimab/Retlirafusp alfa IV +Recaticimab SC + platinum-based chemotherapy IV, 21-day cycle

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What researchers measure

Primary outcomes

  1. pCR rate

    Pathological complete response rate

    Time frame: four weeks after surgery

Secondary outcomes

  1. MPR rate

    major pathologic response rate

    Time frame: four weeks after surgery

  2. ORR

    objective response rate

    Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years

  3. EFS

    event free survival

    Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years

  4. OS

    overall survival

    Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07567326
Lead sponsor
Peking University Cancer Hospital & Institute
Responsible party
Sponsor
First posted
May 5, 2026
Start date
Jul 2026 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Dec 2030 (estimated)
Last update
May 5, 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 Apr 2026. You cannot join it, but the record below documents what was studied.

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