AzTrials
AzTrials

Adebrelimab (SHR-1316)Phase 2NCT07035392

Adebrelimab + Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC

A Phase 2 study testing Adebrelimab and chemotherapy in people with Adebrelimab (SHR-1316) and NSCLC, run by Zhangzhou Municipal Hospital.

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

This study is a single arm, prospective, multicenter clinical trial, and eligible patients will receive the following treatment regimen: Adebrelimab combined with chemotherapy.The study includes a screening period (from the signing of informed consent by the subjects to no more than 28 days before the first… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Adebrelimab (SHR-1316), NSCLC, Chemotherapy
What is being tested?
Adebrelimab and chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
No sites listed yet
Study dates
20 Jun 2025to 1 Dec 2026
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

  • 18 years old ≤ age ≤ 70 years old, male or female not limited;
  • ECOG PS score 0-1 points;
  • Patients who have not received systematic treatment in the past and agree to undergo radical surgery; Patients without surgical contraindications judged by thoracic surgeons;
  • Stage II, IIIA, or selective IIIB (T3N2M0 only) squamous or non squamous cell non-small cell lung cancer confirmed by histopathology or cytology and judged by researchers to be capable of undergoing R0 surgical resection for the purpose of cure. Disease staging should be based on the American Joint Committee on Cancer (AJCC)/International Union Against Cancer (UICC) NSCLC staging system, 8th edition;
  • There is sufficient tumor tissue to detect PD-L1 expression level and PD-L1 ≥ 1%;
  • At least one measurable lesion (according to RECIST 1.1 criteria);
Show all 17Show fewer
  • The expected survival period is at least 12 weeks;
  • Other major organs (liver, kidney, blood system, etc.) are functioning well:
  • Hemoglobin ≥ 90g/L (no blood transfusion, no use of hematopoietic factors, and no medication correction within 2 weeks before the first medication);
  • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L;
  • Platelet count ≥ 100 × 109/L; Total bilirubin ≤ 1.5 times the upper limit of normal value;
  • alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase ≤ 2.5 times the upper limit of normal values;
  • Serum creatinine ≤ 1.5 times the upper limit of normal value; And the endogenous creatinine clearance rate is ≥ 60ml/min; For patients who have not received anticoagulant therapy, the international normalized ratio (INR) of prothrombin time is ≤ 1.5, and the activated partial thromboplastin time (APTT) is ≤ 1.5 times the upper limit of normal.
  • Expected to be completely resected;
  • Good lung function can tolerate surgical treatment;
  • Female participants with fertility must undergo a pregnancy test (serum or urine) within 72 hours before starting the study medication, and the result must be negative. They must also be willing to use a medically recognized and effective contraceptive measure (such as intrauterine device, contraceptive pill, or condom) during the study period and within 90 days after the last administration of the study medication; For male participants whose partners are women of childbearing age, they must agree to use effective methods of contraception or have undergone surgical sterilization during the study period and within 90 days after the last study administration;
  • The subjects voluntarily joined this clinical study and signed an informed consent form.

Who cannot join

  • Previously received any anti-tumor treatment, including radiotherapy, chemotherapy, immunotherapy, and traditional Chinese medicine anti-tumor treatment (excluding treatment for malignant tumors that have been cured and have no recurrence or metastasis for ≥ 5 years);
  • Non squamous cell carcinoma histological types of NSCLC with EGFR mutation positive or ALK positive subjects. Non squamous cell carcinoma subjects must undergo EGFR gene testing and ALK gene and/or immunohistochemical testing;
  • Patients with distant metastases (including M1a, M1b, M1c);
  • Suffering from any active autoimmune disease or history of autoimmune disease (such as uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which can be included after hormone replacement therapy), tuberculosis); Skin diseases that have completely relieved childhood asthma and do not require any intervention or systemic treatment in adulthood (such as vitiligo, psoriasis, or hair loss) can be included, but patients who require medical intervention with bronchodilators cannot be included;
  • Exclude evidence of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiological pneumonia, drug-induced pneumonia, imaging confirmed active pneumonia, and severe impairment of lung function;
  • Subjects who have received systemic therapy with corticosteroids (>10 mg/day of prednisone or other equivalent hormones) or other immunosuppressive agents within 2 weeks prior to their first administration. In the absence of active autoimmune diseases, inhalation or topical use of corticosteroids is allowed, as well as adrenal hormone replacement therapy with a dose of ≤ 10 mg/day effective dose of prednisone;
Show all 20Show fewer
  • Imaging (CT or MRI) shows tumor invasion into large blood vessels or blurred boundaries with blood vessels; Or imaging (CT or MRI) shows the presence of any pulmonary cavities or necrotic lesions, as determined by the researcher;
  • Individuals who have experienced arterial/venous thrombotic events within the first 6 months of enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
  • Within the first 3 months of enrollment, there have been significant clinically significant bleeding symptoms or clear bleeding tendencies, such as gastrointestinal bleeding, hemorrhagic gastric ulcers, etc., or they are currently receiving thrombolytic or anticoagulant therapy;
  • Prior to enrollment, there was a daily hemoptysis volume of 100mL or more or a high risk of hemoptysis determined by the researcher;
  • Individuals with hypertension who cannot achieve good control with antihypertensive medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval ≥ 450ms for males and ≥ 470ms for females); According to NYHA standards, patients with grade III-IV cardiac dysfunction or those with left ventricular ejection fraction (LVEF)<50% as indicated by cardiac ultrasound examination;
  • Individuals who have undergone other major surgeries or severe injuries within the two months prior to the start of this experiment;
  • Urine routine examination indicates urinary protein ≥ (++), or 24-hour urine protein level ≥ 1g, or severe liver and kidney dysfunction;
  • Uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
  • Allergic to the experimental drug;
  • Merge with HIV infection or active viral hepatitis;
  • Pregnant or lactating women; Subjects with fertility who are unwilling or unable to take effective contraceptive measures;
  • Individuals with neurological disorders or mental illnesses who are unable to cooperate;
  • Cervical carcinoma in situ, basal cell or squamous cell carcinoma that can be adequately treated, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery are excluded from concurrent malignant tumors occurring ≤ 5 years before enrollment;
  • Researchers believe that there are other situations that are not suitable for inclusion.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Zhen Huang contact

13960025158

huangzhen640@163.com

About this study

Official title: A Single-arm, Prospective, Multicenter Clinical Study of Adebrelimab in Combination With Chemotherapy Neoadjuvant Therapy to Resect Non-small Cell Lung Cancer

This study is a single arm, prospective, multicenter clinical trial, and eligible patients will receive the following treatment regimen: Adebrelimab combined with chemotherapy.The study includes a screening period (from the signing of informed consent by the subjects to no more than 28 days before the first medication, imaging examinations are allowed to be performed within 28 days before the first medication, and tumor tissue biopsy is allowed to be archived within 6 months before the first medication), a treatment period (including neoadjuvant and surgical treatment), and a follow-up period (including safety follow-up and survival follow-up).

Being tested
Adebrelimab, chemotherapy

What participants receive

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

  • AdebrelimabDrug

    Adebrelimab 1200mg，ivgtt，D1，Q3W

  • chemotherapyDrug

    Queue A (lung squamous cell carcinoma patients):

    Albumin paclitaxel 260mg/m2, ivgtt，D1 , Q3W Carboplatin AUC=5, D1，Q3W

    Queue B (lung adenocarcinoma patients):

    Pemetrexed 500 mg/m2, ivgtt，D1，Q3W Carboplatin AUC=5, D1，Q3W

Study groups in NCT07035392
Study groupRoleWhat they receive
Adebrelimab in combination chemotherapyExperimentalNot described
Receives: Drug: Adebrelimab; Drug: chemotherapy

What is being measured

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

  1. Main pathological relief (MPR)

    Main pathological relief (MPR) is defined as less than or equal to 10% of active tumor tissue in the surgical specimen during tumor resection.

    Measured: Four weeks after surgery

Secondary outcomes (4)

  1. pathologic complete response（pCR）

    Measured: Four weeks after surgery

  2. Surgical R0 resection rate

    Measured: Four weeks after surgery

  3. objective response rate(ORR)

    Measured: Up to 3 months per two cycles (21 days per cycle)

  4. The incidence and severity of adverse events (including serious adverse reactions)

    Measured: Up to 24 weeks

Timeline

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

  1. First posted25 Jun 2025
  2. Study start20 Jun 2025 (estimated)
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2026 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07035392
Sponsor's protocol ID
2024KYZ432
Status last verified
Mar 2025
First submitted
22 May 2025
Last updated
25 Jun 2025
Results posted
No
Data monitoring committee
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 2 study testing Adebrelimab and chemotherapy in people with Adebrelimab (SHR-1316) and NSCLC, run by Zhangzhou Municipal 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 17 inclusion and 20 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 25 Jun 2025. 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 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 Zhen Huang (13960025158, huangzhen640@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Main pathological relief (MPR) (time frame: Four weeks after surgery). 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 NCT07035392.

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 25 Jun 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in