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

Sponsor
Universität des Saarlandes
Study ID
NCT06223711
Phase
PHASE2
Status
Recruiting
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Conditions

  • Extensive-stage Small-cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Thoracic Radiochemotherapy — RADIATION
    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).
  • durvalumab — DRUG
    Durvalumab is administered in fixed dose 1500mg in q3w cycles concomitant to chemotherapy and q4w cycles during maintenance treatment
  • Stereotactic radiotherapy of further tumor locations — RADIATION
    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.
  • Chemotherapy — DRUG
    Concomitant chemotherapy consists of further two cycles platinum/etoposide q3w (summarized cycle 3-4).

Study Details

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

Key Dates

Start date
Oct 6, 2023
Status verified
Apr 2024
Primary completion
Mar 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
43 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Thoracic Radiochemotherapy concomitant 2 cycles of etoposide/platinum + durvalumab Stereotactic radiotherapy of further tumor locations + durvalumab maintenance

Primary Outcome Measure

Progression-free survival (PFS) rate [ Time Frame: 12 month ]

Central Contacts

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