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Not yet recruitingNCT07909863Updated Nov 4, 2026

Low-Dose Radiotherapy Plus Adebrelimab and Chemotherapy for Extensive-Stage Small Cell Lung Cancer

A Phase 2 interventional study of Adebrelimab + Chemotherapy + Radiotherapy in Small Cell Lung Cancer (SCLC) and SCLC, Extensive Stage, sponsored by Tianjin Medical University Cancer Institute and Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Tianjin Medical University Cancer Institute and Hospital · Phase 2, Interventional, and Treatment

Updated Nov 4, 2026Eligibility revisedNewly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is a phase II study evaluating a novel combination therapy for untreated extensive-stage small cell lung cancer. The treatment involves an initial induction phase with the drug Adebrelimab plus standard chemotherapy and low-dose radiotherapy, followed by an Adebrelimab maintenance phase. The primary objective is to assess the efficacy of this approach in prolonging overall survival (OS) and to evaluate its safety in approximately 25 patients.

Read the detailed description

This is an exploratory Phase II clinical trial for previously untreated extensive-stage small cell lung cancer (ES-SCLC). The study evaluates a two-phase treatment strategy: patients first receive induction therapy with Adebrelimab combined with standard chemotherapy (EC or EP regimen) and concurrent low-dose radiotherapy (5 Gy × 5 fractions); patients achieving disease control then proceed to the maintenance phase with Adebrelimab for up to 2 years. The primary objective is to assess the regimen's efficacy in prolonging overall survival (OS). Secondary objectives include evaluating progression-free survival (PFS), objective response rate (ORR), and safety. The study plans to enroll approximately 25 patients.

02

Conditions studied

  • Small Cell Lung Cancer (SCLC)
  • SCLC, Extensive Stage
03

In context

Small Cell Lung Carcinoma

1,240 studies on the registry are indexed under Small Cell Lung Carcinoma; 354 are open to participants now.

This study's planned enrollment of 25 is below the median of 56 across 1,062 interventional studies indexed under Small Cell Lung Carcinoma.

Browse Small Cell Lung Carcinoma studies →

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 493 studies on the registry; 292 are open to participants now.

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

04

Who can participate

The criteria were revised on the registry on Nov 4, 2026. See what changed

Ages eligible
18 Years to 75 Years
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.Patients with pathologically confirmed extensive-stage small cell lung cancer (ES-SCLC) according to VALG staging.
  • 2. No prior systemic therapy for extensive-stage small cell lung cancer.
  • 3. Presence of measurable lesions as defined by RECIST 1.1. A previously irradiated lesion may be considered measurable only if clear progression occurs after radiotherapy and this previously irradiated lesion is not the only lesion.
  • 4. Aged 18-75 years.
  • 5. ECOG performance status: 0-2.
  • 6. Expected survival ≥3 months.
  • 7. Adequate hematological and organ function, i.e., meeting the following criteria:

    a) Hematology (no blood transfusion or blood products and no use of G-CSF or other hematopoietic growth factors for correction within 14 days): i. Absolute neutrophil count (ANC) ≥1.5×10\^9/L (1,500/mm\^3); ii. Platelet count (PLT) ≥100×10\^9/L (100,000/mm\^3); iii. Hemoglobin (HB) ≥80 g/L. b) Renal: i. Calculated creatinine clearance (CrCl) ≥50 mL/min; ii. Urine protein \<2+ or 24-hour urine protein \<1.0 g. c) Hepatic: i. Serum total bilirubin (TBil) ≤1.5×ULN; ii. AST and ALT ≤2.5×ULN; iii. Serum albumin (ALB) ≥28 g/L. d) Coagulation: i. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5×ULN.

    e) Cardiac: i. Left ventricular ejection fraction (LVEF) ≥50%.

  • 8. Female patients must meet one of the following conditions:

    1. Menopause (defined as no menstruation for at least 1 year and no other confirmed cause other than menopause); or
    2. Surgical sterilization (oophorectomy and/or hysterectomy); or
    3. Fertile but must meet:

    i. Serum pregnancy test within 3 days before drug administration must be negative; ii. Agree to use contraceptive measures with an annual failure rate \<1% (from signing the ICF until at least 6 months after the last dose of the study drug); iii. Must not breastfeed.

  • 9. Male patients must take contraceptive measures as follows: when the partner is a woman of childbearing potential or the partner is pregnant, the male patient must remain abstinent or use a condom during the study treatment period and for at least 6 months after the last dose of the study drug to prevent embryonic exposure to the drug.
  • 10. Participants voluntarily agree to participate in this study, sign the informed consent form (ICF), have good compliance, and are willing to cooperate with follow-up.

Exclusion criteria

Exclusion Criteria:

  • 1. Patients with symptomatic brain metastases. Patients may be enrolled if symptoms remain clinically stable for at least 1 month after treatment of brain metastasis lesions and no steroids or anticonvulsants have been used for at least 1 month before study entry.
  • 2. Patients who have previously received thoracic radiotherapy for limited-stage SCLC.
  • 3. Prior use of anti-angiogenic drugs such as anlotinib, apatinib, and bevacizumab, or related immunotherapy drugs targeting PD-1, PD-L1, etc.
  • 4. Factors affecting oral medication (e.g., inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction, etc.).
  • 5. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • 6. Imaging shows that the tumor has invaded the periphery of major blood vessels, or the investigator judges that during the subsequent study period the tumor is highly likely to invade major blood vessels and cause fatal massive bleeding.
  • 7. History of severe bleeding tendency or coagulation dysfunction, including but not limited to: clinically significant hemoptysis within 3 months before enrollment (>1 tablespoon per day); or clinically significant bleeding symptoms or bleeding tendency within 4 weeks before grouping, such as gastrointestinal bleeding, bleeding gastric ulcer (including gastrointestinal perforation and/or fistula; however, patients with gastrointestinal perforation or fistula that has been surgically resected may be allowed to enroll), unhealed wounds, ulcers, or fractures, etc.
  • 8. Major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days before grouping.
  • 9. Arterial/venous thrombotic events within 6 months before grouping, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism.
  • 10.Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the first dose.
  • 11.Other conditions that increase the risk of participating in the study or are related to the study drug and, according to the investigator's judgment, may make the patient unsuitable for inclusion in the study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Experimental Group

    Patients receive Adebrelimab (1200 mg IV Q3W) combined with standard chemotherapy (EC or EP regimen) for 4 induction cycles. Concurrent low-dose radiotherapy (5 Gy per fraction for 5 fractions) is administered during Cycle 1 or Cycle 2. Following induction, patients without disease progression (non-PD) continue to receive Adebrelimab (1200 mg IV Q3W) as maintenance therapy for up to 2 years, or until disease progression, unacceptable toxicity, or withdrawal of consent.

    Combination Product: Adebrelimab + Chemotherapy + Radiotherapy

Interventions

  • Combination productAdebrelimab + Chemotherapy + Radiotherapy

    Participants receive a two-phase treatment regimen. Induction (4 fixed cycles, q3w): Adebrelimab (1200 mg IV over 60 minutes, Day 1) followed by investigator's choice of standard platinum-etoposide chemotherapy (EC regimen: Carboplatin AUC=5 on Day 1 + Etoposide 100 mg/m² on Days 1-3; or EP regimen: Cisplatin 75 mg/m² on Day 1 + Etoposide 100 mg/m² on Days 1-3). Concurrent hypofractionated radiotherapy to the primary lung lesion (5 Gy per fraction for 5 fractions) is administered during Cycle 1 or Cycle 2. Maintenance: Patients without disease progression after 4 cycles continue Adebrelimab (1200 mg IV, q3w) for up to 2 years, until disease progression (per RECIST v1.1), unacceptable grade ≥3 immune-related toxicity, or withdrawal of consent.

06

What researchers measure

Primary outcomes

  1. Overall Survival (OS)

    OS is defined as the time from enrollment to death from any cause.

    Time frame: From enrollment until death from any cause, assessed up to approximately 24 months.

Secondary outcomes

  1. Progression-Free Survival (PFS)

    PFS is defined as the time from enrollment to objective tumor progression (per RECIST v1.1) or death from any cause, whichever occurs first.

    Time frame: From enrollment until disease progression or death, assessed up to approximately 24 months.

  2. Objective Response Rate (ORR)

    ORR is defined as the proportion of patients achieving a confirmed Complete Response (CR) or Partial Response (PR) as assessed by the Independent Review Committee (IRC) according to RECIST v1.1. Patients must have measurable disease at baseline.

    Time frame: Assessed at baseline, after induction, and every 3 months during maintenance, up to approximately 24 months.

  3. Safety and Tolerability

    Incidence, severity, and frequency of adverse events (AEs) and serious adverse events (SAEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0.

    Time frame: From enrollment until 90 days after the last dose of study treatment.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates 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 Nov 2026; primary completion for Sep 2027, 9 months later.

Of 154 non-industry phase 2 interventional studies under Small Cell Lung Carcinoma, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 83. This study's planned 9 months is below that.

Counting every sponsor, half of 203 studies reached it within 44 months; a quarter within 29 and three quarters within 75.

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

Registered
Oct 27, 2026
First posted
Nov 2, 2026
StartEst.
Nov 15, 2026
Primary completionEst.
Sep 1, 2027
CompletionEst.
Sep 1, 2028
Last update
Nov 4, 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.
Eligibility
5 inclusion criteria edited, 9 added; 2 exclusion criteria edited
What changed in the criteria
Inclusion criteria
  • Edited1. Patients with pathologically confirmed extensive-stage small cell lung cancer (ES-SCLC) according to VALG staging.
  • Added2. No prior systemic therapy for extensive-stage small cell lung cancer.
  • Edited2. No prior systemic therapy for extensive-stage small cell lung cancer. 3. Presence of measurable lesions as defined by RECIST 1.1. A previously irradiated lesion may be considered measurable only if clear progression occurs after radiotherapy and this previously irradiated lesion is not the only lesion.
  • Added4. Aged 18-75 years.
  • Added5. ECOG performance status: 0-2.
  • Added6. Expected survival ≥3 months.
  • Edited4. Aged 18-75 years. 5. ECOG performance status: 0-2. 6. Expected survival ≥3 months. 7. Adequate hematological and organ function, i.e., meeting the following criteria:
  • EditedCardiac: i. Left ventricular ejection fraction (LVEF) ≥50%. 8. Female patients must meet one of the following conditions:
  • Added8. Female patients must meet one of the following conditions:
  • AddedMenopause (defined as no menstruation for at least 1 year and no other confirmed cause other than menopause); or
  • AddedSurgical sterilization (oophorectomy and/or hysterectomy); or
  • AddedFertile but must meet:
  • AddedSerum pregnancy test within 3 days before drug administration must be negative; ii. Agree to use contraceptive measures with an annual failure rate <1% (from signing the ICF until at least 6 months after the last dose of the study drug); iii. Must not breastfeed.
  • EditedMenopause (defined as no menstruation for at least 1 year and no other confirmed cause other than menopause); or b. Surgical sterilization (oophorectomy and/or hysterectomy); or c. Fertile but must meet: i. Serum pregnancy test within 3 days before drug administration must be negative; ii. Agree to use contraceptive measures with an annual failure rate <1% (from signing the ICF until at least 6 months after the last dose of the study drug); iii. Must not breastfeed. 9. Male patients must take contraceptive measures as follows: when the partner is a woman of childbearing potential or the partner is pregnant, the male patient must remain abstinent or use a condom during the study treatment period and for at least 6 months after the last dose of the study drug to prevent embryonic exposure to the drug.
Exclusion criteria
  • Edited10. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the first dose.
  • Edited11. Other conditions that increase the risk of participating in the study or are related to the study drug and, according to the investigator's judgment, may make the patient unsuitable for inclusion in the study.
Nov 4, 2026
Registered
First appeared on the registry
Nov 2, 2026
Show all 2 updates
  1. Nov 4, 2026
    Eligibility 5 inclusion criteria edited, 9 added; 2 exclusion criteria edited
    What changed in the criteria
    Inclusion criteria
    • Edited1. Patients with pathologically confirmed extensive-stage small cell lung cancer (ES-SCLC) according to VALG staging.
    • Added2. No prior systemic therapy for extensive-stage small cell lung cancer.
    • Edited2. No prior systemic therapy for extensive-stage small cell lung cancer. 3. Presence of measurable lesions as defined by RECIST 1.1. A previously irradiated lesion may be considered measurable only if clear progression occurs after radiotherapy and this previously irradiated lesion is not the only lesion.
    • Added4. Aged 18-75 years.
    • Added5. ECOG performance status: 0-2.
    • Added6. Expected survival ≥3 months.
    • Edited4. Aged 18-75 years. 5. ECOG performance status: 0-2. 6. Expected survival ≥3 months. 7. Adequate hematological and organ function, i.e., meeting the following criteria:
    • EditedCardiac: i. Left ventricular ejection fraction (LVEF) ≥50%. 8. Female patients must meet one of the following conditions:
    • Added8. Female patients must meet one of the following conditions:
    • AddedMenopause (defined as no menstruation for at least 1 year and no other confirmed cause other than menopause); or
    • AddedSurgical sterilization (oophorectomy and/or hysterectomy); or
    • AddedFertile but must meet:
    • AddedSerum pregnancy test within 3 days before drug administration must be negative; ii. Agree to use contraceptive measures with an annual failure rate <1% (from signing the ICF until at least 6 months after the last dose of the study drug); iii. Must not breastfeed.
    • EditedMenopause (defined as no menstruation for at least 1 year and no other confirmed cause other than menopause); or b. Surgical sterilization (oophorectomy and/or hysterectomy); or c. Fertile but must meet: i. Serum pregnancy test within 3 days before drug administration must be negative; ii. Agree to use contraceptive measures with an annual failure rate <1% (from signing the ICF until at least 6 months after the last dose of the study drug); iii. Must not breastfeed. 9. Male patients must take contraceptive measures as follows: when the partner is a woman of childbearing potential or the partner is pregnant, the male patient must remain abstinent or use a condom during the study treatment period and for at least 6 months after the last dose of the study drug to prevent embryonic exposure to the drug.
    Exclusion criteria
    • Edited10. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the first dose.
    • Edited11. Other conditions that increase the risk of participating in the study or are related to the study drug and, according to the investigator's judgment, may make the patient unsuitable for inclusion in the study.
  2. Nov 2, 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
NCT07909863
Responsible party
Sponsor
First posted
Nov 2, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
Sep 1, 2027 (estimated)
Completion
Sep 1, 2028 (estimated)
Last update
Nov 4, 2026

Study contacts

Ningbo Liu
Contact
liuningbo@tjmuch.com
+8615602036608
Ningbo Liu, Doctor
principal investigator · Tianjin Medical University Cancer Institute and Hospital

Oversight

Data monitoring committee
No
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 Sep 2026. You cannot join it, but the record below documents what was studied.

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