Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-Dose Radiotherapy + EP/EC + Adebrelimab | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etoposide | Drug | Etoposide 100 mg/m² intravenously on days 1-3, plus Cisplatin 75 mg/m² intravenously on day 1, repeated every 21 days (q3w). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival(PFS) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cisplatin | Drug | Etoposide 100 mg/m² intravenously on days 1-3, plus Cisplatin 75 mg/m² intravenously on day 1, repeated every 21 days (q3w). |
|
| Carboplatin | Drug | 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). |
|
| Adebrelimab | Drug | 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. |
|
| Thoracic Radiotherapy | Radiation | Radiotherapy will be delivered to the primary tumor in the lung, involved regional lymph nodes, and metastatic pleural lesions. |
|
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) | 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 | 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 | 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. |
| ID | Term |
|---|---|
| D005047 | Etoposide |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
Not provided
Not provided