Active — Not RecruitingPhase 2

Durvalumab Maintenance After Thoracic Chemoradiotherapy in Frail Small Cell Lung Cancer Patients Whose Disease is Limited to the Thorax

France100 participantsStarted 2023-03-24

Plain-language summary

This study is an academic-lead, open-label, multicenter, randomized phase II trial for frail limited disease Small Cell Lung Cancer (LD-SCLC) patients. Frail conditions are: Eastern Cooperative Oncology Group performance status (ECOG PS) 2 or ECOG PS 0-1 and older than 70 or ECOG PS 0-1 and did not receive a concomitant thoracic chemo-radiotherapy (CRT) because of comorbidities. During the screening phase, patients complete either the standard concomitant or sequential thoracic CRT and cisplatin-etoposide regimen or carboplatin AUC5 to AUC6 etoposide regimen. Patients showing a disease control (defined as stable disease \[SD\], partial response \[PR\], or complete response \[CR\] according to RECIST v1.1) at the radiological evaluation performed after the end of thoracic CRT can receive prophylactic cranial irradiation (PCI) as per local practice. They will then be treated by durvalumab every 4 weeks. DURVALUNG study aims to evaluate the activity of durvalumab maintenance treatment in frail LD-SCLC patients who have not progressed following platinum-based concomitant or sequential CRT.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patient must have signed a first written informed consent form prior to screening visit and to any trial specific procedures.
✓. Histological confirmation of SCLC.
✓. Limited disease (T0-T4, N0-N3 and M0) according to the TNM classification 8th edition or to the VALSG 2-stage classification. As per standard guidelines a complete radiological evaluation has to be performed within 28 days before the start of induction chemotherapy including all the radiological exams below:
✓. Measurable disease according to RECIST v1.1 criteria.
✓. Patients must not have been previously treated for the SCLC. Note: patients who have already begun the initial CRT are eligible.
✓. Patients ≥18 years old.
✓. Body weight \>30 kg.
✓. Patients can be candidate to concomitant or sequential thoracic CRT by IMRT. Patients have to receive at least 60 Gy (one-daily fraction of 1.8-2 Gy) or 45 Gy twice daily (1.5 Gy per fraction) combined with cisplatin-etoposide regimen or with carboplatin AUC5 to AUC6 etoposide regimen.

Exclusion criteria

What they're measuring

Progression-free survival

Timeframe: From inclusion to disease progression or death, up to 3.5 years

Trial details

NCT IDNCT05617963

SponsorUNICANCER

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-02-24

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