CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 58 target
Drug / intervention
Durvalumab +2 moredrug
Likely dose
Durvalumab 10mg/Kgfrom record
Key inclusion· 11
  • Age 18-75 years old
  • Histologically or cytologically confirmed limited-stage SCLC (TNM: any T, any N, M0)
  • Patients with suspected brain or bone metastasis must undergo brain MRI or ECT before enrollment
  • Has immunohistochemical results
Key exclusion· 16
  • Distant organ metastases (excluding supraclavicular lymph nodes)
  • Prior radiotherapy to the chest
  • Medical contraindications to etoposide-platinum chemotherapy
  • Active or history of autoimmune disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06371482
NCT06371482Phase 2RecruitingUpdate OverdueUpdated 24mo ago · Completion was 18mo ago
Enrollment Stalled
Long Recruiting
Update Overdue

Durvalumab Combined With Chemoradiotherapy for Limited Stage Small Cell Lung Cancer

Hebei Medical University Fourth Hospital·interventional·Posted Apr 17, 2024·Updated Jun 17, 2024

In Brief

A Phase 2 clinical trial evaluating Durvalumab, Chemotherapy drug of EP regimen, and 1 other intervention for SCLC, Limited Stage. Currently recruiting, targeting 58 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

This trial aims to assess efficacy and safety of durvalumab combined with chemoradiotherapy for limited stage small cell lung cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 2Recruiting
20242025202620272028
First PostedApr 17, 2024
Enrollment StartJun 1, 2023
Primary CompletionDec 31, 2024
Study CompletionDec 31, 2027
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 2.2 years ago

Interventions

Durvalumabdrug

Durvalumab is an immunoglobulin G (IgG) 1-κsubtype monoclonal antibody (mAb) that blocks the interaction of PD-L1 with PD-1 in T cells and CD80 (B7.1) in immune cells (ics). Durvalumab is developed by Astrazeneca /MedImmune for the treatment of cancer. Durvalumab is designed to reduce the cytotoxicity of antibody-dependent cells and complement dependent cytotoxicity. In vitro studies have demonstrated that Durvalumab can antagonize the inhibition of PD-L1 in human primary T cells, causing them to resume proliferation and release interferon gamma (IFNγ). To date, more than 1,800 patients have been treated with valiuzumab as a single agent or in combination with other cancer agents as part of ongoing studies. Durvalumab: 10mg/Kg, intravenously, starting at week 7 every 3 weeks for at least 1 year, or until progression, intolerance, or spontaneous withdrawal of the patient.

Chemotherapy drug of EP regimendrug

Etoposide: 80-100mg/m², intravenous infusion, given at week 1, 4, 7, 10, 13, 16, a total of 6 cycles. Carboplatin: AUC=5-6, intravenous infusion, given at weeks 1, 4, 7, 10, 13, 16, a total of 6 weeks. Or cisplatin: 75-80mg/m2 intravenously, given at weeks 1, 4, 7, 10, 13, 16 for a total of 6 weeks.

radiotherapyradiation

Radiotherapy: Total dose of 60Gy/30 times, each time 2.0Gy, 5 times a week from week 7 to week 12 of radiotherapy.