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Non-Small Cell Lung CancerPhase 2NCT07031154

A Single-arm, Multicenter, Prospective Clinical Study of Adebrelimab Combined With Apatinib Neoadjuvant Therapy for Resectable Non-small Cell Lung Cancer

A Phase 2 study testing Adebrelimab and Apatinib in people with Non-Small Cell Lung Cancer and Adebrelimab, run by The First Affiliated Hospital of Xiamen University 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
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Trial summary

To evaluate the major pathological response rate of Adibelimab combined with Apatinib neoadjuvant therapy in resectable non-small cell lung cancer. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Non-Small Cell Lung Cancer, Adebrelimab, Apatinib
What is being tested?
Adebrelimab and Apatinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteChina
Study dates
30 Jun 2025to 1 Feb 2027
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

  • Participants must meet all of the following criteria to be enrolled in the study:
  • 18 years old ≤ age ≤70 years old, male or female;
  • ECOG PS score 0-1;
  • Patients who have not received systematic treatment before and agree to receive radical surgical treatment; Thoracic surgeons judge patients with no contraindications to surgery;
  • Stage II, IIIA, or selective stage IIIB (T3N2M0 only) squamous cell or non-squamous non-small cell lung cancer confirmed by histopathology or cytology and determined by the investigator to be capable of R0 resection for curative purposes. Staging should be based on the American Joint Committee on Cancer (AJCC)/Union International Against Cancer (UICC) NSCLC Staging System Version 8;
  • Not allowed to invade the heart, great blood vessels, trachea, recurrent laryngeal nerve, esophagus, vertebrae, protuberances,And T4 tumors with dispersed tumor nodules in different lung lobes on the same side;
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  • Upper lung groove cancer is not allowed;N2 was defined as mediastinal lymph node non-giant metastases (lymph node diameter < 2cm) confirmed by imaging or pathology and expected to be completely resectable.
  • There were enough tumor tissues to detect PD-L1 expression and PD-L1 ≥1%;
  • At least one measurable lesion (according to RECIST 1.1 criteria);
  • Expected survival of at least 12 weeks;
  • Other major organs (liver, kidney, blood system, etc.) function well:
  • Hemoglobin ≥90g/L (no blood transfusion, no hematopoietic factors, and no drug correction within 2 weeks prior to the first dose);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 value;
  • Serum creatinine ≤1.5 times the upper limit of normal value; And endogenous creatinine clearance ≥60ml/min;
  • International Standardized Ratio of prothrombin time (INR)≤1.5 and activated partial thromboplastin time (APTT)≤1.5 times the upper limit of normal for patients who have not received anticoagulant therapy.
  • No systemic metastasis (including M1a, M1b, M1c);
  • Complete excision is expected;
  • Lung function is good and can tolerate surgical treatment;
  • Fertile female subjects must have a negative pregnancy test (serum or urine) within 3 days prior to the start of the study drug, and be willing to use a medically approved highly effective contraceptive during the study period and 90 days after the last study drug administration(e.g. intrauterine devices, contraceptives, or condoms); Male subjects whose partner is a woman of reproductive age must consent to use effective contraception or have been surgically sterilized during the study period and 90 days after the last study dosing;
  • Subjects voluntarily participate in this clinical study and sign informed consent.

Who cannot join

  • Subjects will not be admitted to the study if they have any of the following conditions:
  • have received any anti-tumor therapy in the past, including radiotherapy, chemotherapy, immunotherapy and traditional Chinese medicine anti-tumor therapy (except the treatment of malignant tumors with radical treatment and no recurrence and metastasis for more than 5 years);
  • Subjects with non-squamous cell histological types of NSCLC with EGFR mutation positive or ALK positive. Non-squamous cell carcinoma subjects must undergo EGFR gene testing and ALK gene and/or immunohistochemical testing;
  • Patients with distant metastases (including M1a, M1b, and M1c);
  • Have any active autoimmune disease or history of autoimmune disease (such as uveitis, enteritis, hepatitis, pituitaritis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (may be included after hormone replacement therapy), tuberculosis); Skin conditions (such as vitiligo, psoriasis, or alopecia) with complete remission of childhood asthma that do not require any intervention in adulthood and do not require systemic treatment may be included, but patients requiring medical intervention with bronchodilators may not be included;
  • Exclude evidence of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiological pneumonia, drug-induced pneumonia, radiographic evidence of active pneumonia, and severe impairment of lung function;
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  • Subjects who have received systemic treatment with corticosteroids (>10 mg/ day of prednisone or other equivalent hormones) or other immunosuppressants within 2 weeks prior to initial dosing. In the absence of active autoimmune disease, inhaled or topical corticosteroids are permitted, as well as adrenal hormone replacement therapy at doses ≤10 mg/ day of prednisone efficacy;
  • Imaging (CT or MRI) shows that the tumor has invaded large blood vessels or the boundary with blood vessels is blurred; Or imaging (CT or MRI) showing the presence of any pulmonary cavities or necrotic lesions, as determined by the investigator;
  • Patients who had experienced arteriovenous thrombosis events, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism within 6 months before enrollment;
  • Had clinically significant bleeding symptoms or definite bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc., or were receiving thrombolytic or anticoagulant therapy within 3 months before enrollment;
  • Obvious symptoms of hemoptysis or daily hemoptysis volume of 2.5mL or more within 1 month before enrollment;
  • Patients with hypertension who are not well controlled by antihypertensive drugs (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg); Or grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥450ms in men and women)≥470ms); According to NYHA criteria, patients with grade Ⅲ to Ⅳ cardiac insufficiency or left ventricular ejection fraction (LVEF) < 50% indicated by cardiac color ultrasound;
  • Major operations or serious external injuries of other systems were performed within 2 months before the start of the study;
  • Urine routine indicated urinary protein ≥(++), or 24h urinary protein ≥1g or severe hepatic and renal insufficiency;
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
  • Allergic to the experimental drug;
  • Co-existing with HIV infection or active viral hepatitis;
  • Pregnant or lactating women; The fertile subject is unwilling or unable to take effective contraceptive measures;
  • Those who suffer from neurological diseases or mental diseases and cannot cooperate;
  • Other malignancies developed within 5 or less years before admission, excluding adequately treatable cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery;
  • Other situations deemed unsuitable for inclusion by the researcher.

Trial locations and contacts

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

Guan zhi Ye contact

13950073075

xdfyec@sina.com

China1 site

  • First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

Other trials in China

About this study

To evaluate the major pathological response rate of Adibelimab combined with Apatinib neoadjuvant therapy in resectable non-small cell lung cancer.

Being tested
Adebrelimab, Apatinib
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.

  • AdebrelimabDrug

    Adebrelimab 1200mg, iv, D1，Q3W

  • ApatinibDrug

    Apatinib 250mg，P.O，qd，Q3W

Study groups in NCT07031154
Study groupRoleWhat they receive
Adebrelimab in combination ApatinibExperimentalNot described
Receives: Drug: Adebrelimab; Drug: Apatinib

What is being measured

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

  1. Major pathological response (MPR)

    When the tumor was surgically resected, the active tumor tissue in the surgical specimen was less than 10%

    Measured: Four weeks after surgery

Secondary outcomes (4)

  1. Pathological complete response (pCR)

    Measured: Four weeks after surgery

  2. R0 resection rate

    Measured: Four weeks after surgery

  3. Objective response rate (ORR)

    Measured: Up to 3 months per 2 cycles (21 days per cycle)

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

    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 posted22 Jun 2025
  2. Study start30 Jun 2025 (estimated)
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 Feb 2027 (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
43 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07031154
Sponsor's protocol ID
SL-2024KY236-01
Status last verified
Feb 2025
First submitted
21 May 2025
Last updated
22 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 Apatinib in people with Non-Small Cell Lung Cancer and Adebrelimab, run by The First Affiliated Hospital of Xiamen University 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 22 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 22 Jun 2025. 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 Guan zhi Ye (13950073075, xdfyec@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major pathological response (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 NCT07031154.

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 22 Jun 2025.

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