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Low-dose Thoracic Radiotherapy Followed by Adebrelimab Plus Chemotherapy, and Then Sequential Maintenance Therapy With Adebrelimab for Extensive-stage Small Cell Lung Cancer

6. maj 2026 opdateret af: Lin Xiao, Jiangmen Central Hospital

Efficacy and Safety of Low-dose Thoracic Radiotherapy Followed by Adebrelimab Plus Chemotherapy and Sequential Adebrelimab Maintenance Therapy for Extensive-stage Small Cell Lung Cancer: A Prospective, Multicenter Phase II Study

This multicenter, prospective study aims to investigate the efficacy and safety of low-dose radiotherapy (15Gy/1.5 Gy bid × 10 fractions) combined with 4-6 cycles of systemic chemotherapy plus anti-PD-L1 antibody, followed by anti-PD-L1 antibody maintenance for up to two years, in participants with extensive-stage small cell lung cancer (ES-SCLC).

Additionally, dynamic monitoring using next-generation sequencing (NGS) technology will be performed to assess ctDNA levels, genetic information, and mutation abundance at the following time points: before and after low-dose radiotherapy, after 4-6 cycles of chemotherapy plus anti-PD-L1 antibody (chemotherapy-immunotherapy), and before the initiation of anti-PD-L1 maintenance therapy. This approach aims to guide efficacy and prognosis prediction, as well as to identify potential biomarkers associated with treatment response.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This prospective, multicenter study plans to enroll 43 ES-SCLC participants without malignant pleural effusion. All participants will first receive low-dose radiotherapy (15Gy/1.5 Gy bid × 10 fractions), followed by systemic chemotherapy (EP or EC regimen) combined with anti-PD-L1 antibody within one week after radiotherapy completion for 4-6 cycles. After 4-6 cycles of chemo-immunotherapy, anti-PD-L1 antibody maintenance therapy will be continued for two years. This treatment model is expected to achieve survival outcomes (PFS and OS) comparable to or even better than those of the MATCH study from West China Hospital (mPFS 6.9 months) and the NCT04562337 study from Shandong Cancer Hospital (mPFS 6.9-10.1 months), with manageable toxicity.

Furthermore, dynamic monitoring using next-generation sequencing (NGS) technology will be performed to assess ctDNA levels, genetic information, and mutation abundance at three time points: before and after low-dose radiotherapy, and after 4-6 cycles of chemo-immunotherapy (before the initiation of anti-PD-L1 maintenance therapy). This approach is expected to identify potential biomarkers that can guide efficacy and prognosis prediction, thereby better serving clinical practice.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

43

Fase

  • Fase 2

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Age ≥18 years and ≤75 years.
  2. Histologically or cytologically confirmed extensive-stage small cell lung cancer (SCLC).
  3. No prior systemic anti-tumor therapy.
  4. ECOG performance status 0-2 and life expectancy ≥12 weeks.
  5. At least one measurable lesion per RECIST version 1.1.
  6. No brainstem metastasis and no significant neurological symptoms from brain metastases.
  7. All participants must undergo routine contrast-enhanced CT of the chest and upper abdomen, as well as brain MRI, before enrollment. Whole-body PET-CT plus brain MRI is preferred. For participants with limited financial resources who also have significant obstructive pneumonia or atelectasis, an additional chest MRI is recommended.
  8. No malignant pleural effusion or pericardial effusion.
  9. All participants must provide written informed consent.

Exclusion Criteria:

  1. Presence of interstitial pneumonia or infectious fever prior to treatment.
  2. Comorbid autoimmune diseases or long-term oral corticosteroid use (including those who received oral corticosteroids within 14 days prior to treatment).
  3. Prior history of thoracic radiotherapy or thoracic surgery.
  4. Presence of Grade ≥3 hematologic toxicity or hepatic/renal impairment.
  5. Hypersensitivity to adebrelimab.
  6. Significant respiratory symptoms that preclude tolerance to radiotherapy.
  7. Active hepatitis B or hepatitis C infection with ongoing antiviral therapy. Subjects with a documented history of HBV infection who have achieved undetectable HBV levels after prior active treatment at the time of enrollment may be included.
  8. Presence of pleural effusion or pericardial effusion.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Low-Dose Radiotherapy + EP/EC + Adebrelimab
All patients will first receive low-dose radiotherapy. Within one week after completion of radiotherapy, patients will receive concurrent systemic chemotherapy (either EP or EC regimen) combined with adebrelimab for 4-6 cycles. Following the 4-6 cycles of chemo-immunotherapy, patients will continue maintenance therapy with adebrelimab for up to two years.
Medicin: Etoposide
Etoposide 100 mg/m² intravenously on days 1-3, plus Cisplatin 75 mg/m² intravenously on day 1, repeated every 21 days (q3w).
Medicin: Cisplatin
Etoposide 100 mg/m² intravenously on days 1-3, plus Cisplatin 75 mg/m² intravenously on day 1, repeated every 21 days (q3w).
Medicin: Carboplatin
Etoposide 100 mg/m² intravenously on days 1-3, plus Carboplatin area under the curve (AUC) 5 intravenously on day 1, repeated every 21 days (q3w).
Medicin: Adebrelimab
20 mg/kg intravenously on day 1, repeated every 21 days (q3w). Administered concurrently with chemotherapy for 4-6 cycles, followed by maintenance monotherapy for up to 2 years.
Stråling: Thoracic Radiotherapy
Radiotherapy will be delivered to the primary tumor in the lung, involved regional lymph nodes, and metastatic pleural lesions.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-Free Survival（PFS）
Tidsramme: From the date of first radiotherapy to the date of first documented disease progression, metastasis, or death from any cause, assessed up to 24 months.
Time from first radiotherapy to first occurrence of disease relapse/progression (RECIST 1.1), metastasis, or death from any cause.
From the date of first radiotherapy to the date of first documented disease progression, metastasis, or death from any cause, assessed up to 24 months.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: From date of first radiotherapy to date of death from any cause, assessed up to 36 months.
Time from first radiotherapy to death from any cause.
From date of first radiotherapy to date of death from any cause, assessed up to 36 months.
Overall Response Rate (ORR)
Tidsramme: At 3 months after completion of low-dose thoracic radiotherapy.
Proportion of subjects achieving complete response (CR) or partial response (PR) according to RECIST v1.1.
At 3 months after completion of low-dose thoracic radiotherapy.
Disease Control Rate (DCR)
Tidsramme: At 3 months and 6 months after completion of low-dose thoracic radiotherapy.
Proportion of subjects achieving CR, PR, or stable disease (SD) according to RECIST v1.1.
At 3 months and 6 months after completion of low-dose thoracic radiotherapy.
Incidence of Treatment-Emergent Adverse Events
Tidsramme: From date of first low-dose radiotherapy to 30 days after last dose.
Frequency, severity, and relationship of adverse events assessed by CTCAE v5.0.
From date of first low-dose radiotherapy to 30 days after last dose.
Peripheral Blood ctDNA Level
Tidsramme: Within 48 hours pre-first low-dose RT (at SCLC diagnosis); within 48 hours post-low-dose RT; within 48 hours pre-anti-PD-L1 maintenance (post 4-6 cycles EP/EC + adebrelimab); and within 48 hours post-confirmed PD.
Dynamic changes in circulating tumor DNA (ctDNA) concentration in peripheral blood measured by next-generation sequencing (NGS).
Within 48 hours pre-first low-dose RT (at SCLC diagnosis); within 48 hours post-low-dose RT; within 48 hours pre-anti-PD-L1 maintenance (post 4-6 cycles EP/EC + adebrelimab); and within 48 hours post-confirmed PD.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Jiangmen Central Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

30. oktober 2027

Studieafslutning (Anslået)

1. januar 2028

Datoer for studieregistrering

Først indsendt

21. april 2026

Først indsendt, der opfyldte QC-kriterier

6. maj 2026

Først opslået (Faktiske)

13. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026 049 A

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