OncoMatch/Clinical Trials/NCT06223711
Durvalumab With Consolidative Radiochemotherapy and Ablative Stereotactic Radiotherapy in Oligometastatic ES-SCLC
Is NCT06223711 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including durvalumab and Chemotherapy for extensive-stage small-cell lung cancer.
Treatment: durvalumab · Chemotherapy — Open-label, single-arm, prospective multicenter phase II clinical trial to determine the efficacy of immunotherapy with durvalumab concomitant with radiochemotherapy, followed by durvalumab maintenance therapy in combination with stereotactic radiotherapy in extensive stage SCLC
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Disease stage
Required: Stage EXTENSIVE STAGE (VALG), CANNOT BE TREATED WITHIN ONE RADIATION FIELD (VALG)
Metastatic disease required
ES-SCLC according to the Veterans Administration Lung Study Group (VALG) Staging System for SCLC1 (disease extension that cannot be treated within one radiation field)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy (platinum, etoposide) — first-line
previous treatment with two cycles of platinum/etoposide/durvalumab
Must have received: anti-PD-L1 therapy (durvalumab) — first-line
previous treatment with two cycles of platinum/etoposide/durvalumab
Cannot have received: systemic anticancer therapy
Exception: apart from two cycles of etoposide/platinum + durvalumab; prior chemotherapy/immunotherapy/targeted therapy for other malignancy treated with curative intent ≥5 years ago is no exclusion criterion
Prior systemic anticancer therapy (chemotherapy, immunotherapy, targeted therapy), apart from two cycles of etoposide/platinum + durvalumab (prior chemotherapy/ immunotherapy/ targeted therapy for other malignancy treated with curative intent ≥5 years ago is no exclusion criterion).
Cannot have received: concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment
Exception: hormonal therapy for non-cancer-related conditions acceptable
Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
Cannot have received: radiotherapy to >30% of bone marrow or wide field radiation
Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.
Cannot have received: major surgical procedure
Exception: local surgery of isolated lesions for palliative intent is acceptable
Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
Cannot have received: prior durvalumab clinical study (durvalumab)
Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.
Lab requirements
Blood counts
Hemoglobin ≥9.0 g/dL; WBC ≥ 3,000 per mm3; Platelet count >100,000 per mm3
Kidney function
Calculated creatinine CL >40 mL/min by Cockcroft-Gault formula
Liver function
Serum bilirubin ≤1.5 x institutional ULN (except Gilbert's syndrome); AST (SGOT)/ALT (SGPT) ≤2.5 x ULN unless liver metastases present, then ≤5x ULN
Adequate normal organ and marrow function as defined below: * Hemoglobin ≥9.0 g/dL * White Blood Cells (WBC) ≥ 3,000 per mm3 * Platelet count >100,000 per mm3 * Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician. * AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN * Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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