RecruitingPhase 2NCT06371482

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

Durvalumab Combined With Chemoradiotherapy for Limited Stage Small Cell Lung Cancer

Sponsor

Hebei Medical University Fourth Hospital

Enrollment

58 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

SCLC, Limited Stage

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug called durvalumab to the standard chemoradiotherapy treatment can improve outcomes for people with limited-stage small cell lung cancer — a type of lung cancer that has not spread beyond the chest. **You may be eligible if...** - You are 18 to 75 years old with confirmed small cell lung cancer limited to the chest (limited-stage) - Your cancer has not spread to the brain or elsewhere - Your overall health is good (ECOG score of 0 or 1) - You weigh more than 40 kg and are expected to survive at least 6 months - You can receive cisplatin/carboplatin plus etoposide chemotherapy **You may NOT be eligible if...** - Your cancer has already spread outside the chest - You have a prior history of interstitial lung disease - You are pregnant or breastfeeding - You have had prior chest radiation or chemotherapy for this cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDurvalumab

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.

DRUGChemotherapy 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.

RADIATIONradiotherapy

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