NCT06223711

Durvalumab With Consolidative Radiochemotherapy and Ablative Stereotactic Radiotherapy in Oligometastatic ES-SCLC

Durvalumab (MEDI4736) in Combination With Consolidative Radiochemotherapy and Ablative Stereotactic Radiotherapy in Extensive Stage SCLC

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Universität des Saarlandes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is an open-label, prospective, multi-center single-arm phase II trial. Patients with oligometastatic extensive stage SCLC will be enrolled in the trial. In this trial oligometastatic disease is defined as up to five tumor lesions, whereas the primary tumor including mediastinal lymph node metastases counts as one tumor lesion. The primary tumor including lymph node metastases must be suitable for radiochemotherapy and all distant metastases for stereotactic radiotherapy. Patients must have completed systemic therapy with two cycles of platinum/etoposide/durvalumab and have stable disease or partial response according to RECIST 1.1 criteria. After study inclusion, patients receive radiochemotherapy with concomitant durvalumab (MEDI4736). Concomitant chemotherapy consists of further two cycles platinum/etoposide q3w (summarized cycle 3-4). Dosing of chemotherapy is etoposide 90mg/m² body surface area (BSA) day 1-3 in combination with cisplatin 75mg/m² BSA on day 1 or carboplatin area under the curve (AUC) 5 mg/ml per minute on day 1. Split dose of platinum chemotherapy to 2-3 days is an allowed treatment option. Durvalumab is administered in fixed dose 1500mg in q3w cycles concomitant to chemotherapy and q4w cycles during maintenance treatment. Radiotherapy to the primary tumor including mediastinal lymph node metastases is delivered in single fractions of 1.8Gy once daily up to a cumulative dose of 63.0Gy by intensity modulated radiation therapy (IMRT) or volumetric modulated arc therapy (VMAT). In the following, stereotactic radiotherapy is delivered to the up to four further tumor locations during durvalumab maintenance therapy. Sequencing of radiotherapy of the primary tumor and metastases may be changed if radiotherapy of brain, vertebral or other symptomatic metastases is urgently necessary. Stereotactic radiotherapy will be performed according to local standards with established dose and fractionation schemes in ablative doses depending on the affected organ system.

Conditions

• Extensive-stage Small-cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	Thoracic Radiochemotherapy	Radiotherapy to the primary tumor including mediastinal lymph node metastases is delivered in single fractions of 1.8Gy once daily up to a cumulative dose of 63.0Gy by intensity modulated radiation therapy (IMRT) or volumetric modulated arc therapy (VMAT).
DRUG	durvalumab	Durvalumab is administered in fixed dose 1500mg in q3w cycles concomitant to chemotherapy and q4w cycles during maintenance treatment
RADIATION	Stereotactic radiotherapy of further tumor locations	Stereotactic radiotherapy is delivered to the up to four further tumor locations during durvalumab maintenance therapy and will be performed according to local standards with established dose and fractionation schemes in ablative doses depending on the affected organ system.
DRUG	Chemotherapy	Concomitant chemotherapy consists of further two cycles platinum/etoposide q3w (summarized cycle 3-4).

Timeline

• Start date: 2023-10-06
• Primary completion: 2027-03-01
• Completion: 2027-12-01
• First posted: 2024-01-25
• Last updated: 2024-04-05

Locations

5 sites across 1 country: Germany