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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 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

43

Fase

  • Fase 2

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: Etoposide
Etoposide 100 mg/m² intravenously on days 1-3, plus Cisplatin 75 mg/m² intravenously on day 1, repeated every 21 days (q3w).
Droga: Cisplatin
Etoposide 100 mg/m² intravenously on days 1-3, plus Cisplatin 75 mg/m² intravenously on day 1, repeated every 21 days (q3w).
Droga: 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).
Droga: 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.
Radiazione: Thoracic Radiotherapy
Radiotherapy will be delivered to the primary tumor in the lung, involved regional lymph nodes, and metastatic pleural lesions.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-Free Survival（PFS）
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival (OS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Jiangmen Central Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 maggio 2026

Completamento primario (Stimato)

30 ottobre 2027

Completamento dello studio (Stimato)

1 gennaio 2028

Date di iscrizione allo studio

Primo inviato

21 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

6 maggio 2026

Primo Inserito (Effettivo)

13 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2026 049 A

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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