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Lung Cancer, Small CellPhase 2NCT06914050

Hypofractionated Radiotherapy Followed by Chemo-immunotherapy Induction Therapy

A Phase 2 study testing Adebrelimab, EC/EP and SBRT in people with Lung Cancer, Small Cell and Limited-stage Small Cell Lung Cancer (LS-SCLC), run by Tianjin Medical University Cancer Institute and 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
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Trial summary

Radiotherapy can activate local and systemic immune responses through a variety of mechanisms, which can enhance anti-tumor immune effects. The dose fractionation pattern of radiotherapy has an important influence on the occurrence of immune-induced effects. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Adebrelimab, EC/EP and SBRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
Apr 2025to Apr 2028
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

  • 1. Age 18-70 years old; 2. Limited-stage small cell lung cancer (AJCC 8th) confirmed by histology or cytology; 3. Subjects have not received any treatment for SCLC; 4. Have measurable target lesions according to RECIST v1.1; 5. ECOG score of 0-1; 6. Life expectancy ≥ 12 weeks; 7. Normal function of major organs, that is, meet the following criteria:
  • Routine blood tests must meet the following criteria (no blood transfusion, no use of hematopoietic factors, and no use of drug correction within 14 days):
  • ANC ≥ 1.5×109/L;
  • PLT ≥ 100×109/L;
  • HB ≥ 90 g/L;
  • Biochemical tests must meet the following criteria:
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  • TBIL ≤ 1.5×ULN;
  • ALT, AST≤ 2.5×ULN;
  • Serum creatinine sCr≤1.5×ULN, endogenous creatinine clearance ≥50mL/min (Cockcroft-Gault formula);
  • Coagulation function must meet the following requirements: INR≤1.5×ULN and APTT≤1.5×ULN; 8. Female subjects of childbearing age must undergo a serum pregnancy test within 3 days before starting the study medication, and the result must be negative, and they must be willing to use a medically approved high-efficiency contraceptive measure (such as intrauterine contraceptive device, contraceptive pills or condoms) during the study and within 3 months after the last administration of the study medication; for male subjects whose partners are female subjects of childbearing age, they must be surgically sterilized or agree to use an effective contraceptive method during the study and within 3 months after the last administration of the study medication.
  • 9. The subjects voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up visits.

Who cannot join

  • Central nervous system metastasis;
  • Any active autoimmune disease or history of autoimmune disease (including, but not limited to: moderate interstitial pneumonia and above, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis; patients with vitiligo or childhood asthma that has completely resolved and does not require any intervention as an adult can be included; patients who require bronchodilators for medical intervention are not included;
  • Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/mL), hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method) or co-infection with hepatitis B and hepatitis C, active pulmonary tuberculosis;
  • Immunosuppressive drugs have been used within 14 days before the first use of study drugs, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (i.e. no more than 10 mg/day prednisone or its equivalent);
  • Vaccination with live attenuated vaccine within 4 weeks before the first dose or planned during the study;
  • Suffering from other malignant tumors in the past 3 years;
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  • Evidence of past or current pulmonary fibrosis, interstitial pneumonia (grade II or above), pneumoconiosis, radiological pneumonia, drug-induced pneumonia, and severe lung function impairment;
  • Uncontrolled hypertension;
  • Suffering from myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including QTc interval ≥450ms for males and ≥470ms for females). According to NYHA standards, patients with grade III-IV heart failure, or left ventricular ejection fraction (LVEF) <50% indicated by cardiac ultrasound examination, had myocardial infarction within 6 months before enrollment, New York Heart Association grade II or above heart failure, uncontrolled angina pectoris, uncontrolled severe ventricular arrhythmias, clinically significant pericardial disease, or ECG indicating acute ischemia or abnormal active conduction system;
  • Severe infection within 4 weeks before the first medication (such as: intravenous infusion of antibiotics, antifungal or antiviral drugs for more than 7 days), or unexplained fever >38.5°C during the screening period/before the first medication;
  • 1 1. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 12. Pregnant or lactating women; patients with fertility who are unwilling or unable to take effective contraceptive measures; 13. Known to have allergic reactions, hypersensitivity reactions or intolerance to adebrelimab (SHR-1316), etoposide, cisplatin or its excipients; 14. Subjects who are participating in other clinical studies or whose first medication time is less than 4 weeks from the end of the previous clinical study (last medication) or 5 half-lives of the study drug; 15. Subjects with a history of psychotropic drug abuse, alcoholism or drug abuse; 16. The researcher believes that there are any conditions that may harm the subject or cause the subject to be unable to meet or perform the study requirements.

Trial locations and contacts

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

Lujun Zhao, Professor contact

13102258620

zhaolujun@tjmuch.com

About this study

Official title: An Exploratory Study on the Treatment of Limited-stage Small Cell Lung Cancer With Induction Therapy of Adebrelimab Combined With Chemotherapy Followed by Thoracic Radiotherapy After Hypofractionated Radiotherapy

Radiotherapy can activate local and systemic immune responses through a variety of mechanisms, which can enhance anti-tumor immune effects. The dose fractionation pattern of radiotherapy has an important influence on the occurrence of immune-induced effects. Stereotactic body radiation therapy (SBRT) has obvious advantages in activating interferon effects and inducing abscopal effects. SBRT combined with immunity can enhance the abscopal effect induced by radiotherapy and play a synergistic role. The 8Gy×3 fractionation scheme is currently the most widely used stereotactic radiotherapy scheme. Because we conducted this study, the primary lesion received large-fraction partial tumor irradiation and then received adebrelimab combined with chemotherapy induction treatment for 2 cycles, followed by sequential chest radiotherapy for the treatment of limited-stage small cell lung cancer, to explore the effectiveness and safety.

Being tested
Adebrelimab, EC/EP, SBRT, Chest radiotherapy
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

  • AdebrelimabDrug

    Induction therapy：Adebrelimab, 1200mg, d1, q3w, 2 cycles; Maintenance therapy：Adebrelimab, 1200mg, d1, q3w, until disease progression or unbearable toxicity.

  • EC/EPDrug

    Chemotherapy: standard chemotherapy EC/EP

  • SBRTRadiation

    8Gy*3

  • Chest radiotherapyRadiation

    Chest radiotherapy: conventional fractionation mode 2Gy QD total dose 60Gy or 1.5Gy BID total dose 45Gy, according to the patient's physical condition, concurrent EP or EC chemotherapy can be considered

Study groups in NCT06914050
Study groupRoleWhat they receive
Arm 1ExperimentalSERT+Chemo-immunotherapy+CCRT+Immunotherapy maintenance
Receives: Drug: Adebrelimab; Drug: EC/EP; Radiation: SBRT; Radiation: Chest radiotherapy

What is being measured

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

  1. Progress Free Survival

    Measured: 24months

Secondary outcomes (3)

  1. Objective response rate

    Measured: 24months

  2. Overall survival

    Measured: 24months

  3. TRAEs

    Measured: 24months

Timeline

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

  1. First posted6 Apr 2025
  2. Study startApr 2025 (estimated)
  3. Primary completionApr 2026 (estimated)
  4. Study completionApr 2028 (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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06914050
Sponsor's protocol ID
LS-SCLC
Status last verified
Mar 2025
First submitted
30 Mar 2025
Last updated
25 Apr 2025
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 2 study testing Adebrelimab, EC/EP and SBRT in people with Lung Cancer, Small Cell and Limited-stage Small Cell Lung Cancer (LS-SCLC), run by Tianjin Medical University Cancer Institute and 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 11 inclusion and 11 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 Apr 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 Lujun Zhao, Professor (13102258620, zhaolujun@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progress Free Survival (time frame: 24months). 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 NCT06914050.

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 Apr 2025.

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