Durvalumab Combined With Chemoradiotherapy for Limited Stage Small Cell Lung Cancer (Camel-01)

PHASE2RecruitingINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

June 1, 2023

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2027

Conditions
SCLC, Limited Stage
Interventions
DRUG

Durvalumab

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.

DRUG

Chemotherapy drug of EP regimen

"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."

RADIATION

radiotherapy

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

Trial Locations (1)

050011

RECRUITING

Fourth Hospital of Hebei Medical University, Shijiazhuang

All Listed Sponsors
lead

Hebei Medical University Fourth Hospital

OTHER