A Phase III, Randomized, Multicenter, Open-Label, Comparative Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for the First-Line Treatment in Patients with Extensive Disease Small-Cell Lung Cancer (SCLC) (CASPIAN) - A Phase III Randomised Study of Durva+/- Treme combined with SoC as 1st line treatment in ED-SCLC Pt

AstraZeneca AB0 个研究点目标入组 984 人开始时间: 2017年1月26日最近更新: 2024年5月13日

适应症

试验速览

暂无简介。

•1.Histologically or cytologically documented extensive disease (American Joint Committee on Cancer Stage IV SCLC [T any, N any, M1 a/b]), including patients with T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan. Brain metastases; must be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment.
•2. Suitable to receive a platinum-based chemotherapy regimen as 1st line treatment.
•3. Life expectancy =12 weeks at Day 1.
•4. ECOG 0 or 1 at enrolment.
•5. No prior exposure to immune-mediated therapy excluding therapeutic anticancer vaccines.
•6 .Body weight >30 kg.
•7. Adequate organ and marrow function.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 590
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 394

•1. Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy (except paliative care outside of the chest).
•2. Any other concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
•3. History of allogenic organ transplantation.
•4. Paraneoplastic syndrome of autoimmune nature, requiring systemic treatment or clinical symptomatology suggesting worsening of PNS
•5. Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
•6. History of another primary malignancy
•7. Active infection including tuberculosis, HIV, hepatitis B anc C
•8. Current or prior use of immunosuppressive medication within 14 days before the first IP dose
•9. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control..
•10. Past medical history of interstitial lung disease or any evidence of clinically active interstitial lung disease.

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