A study investigating what potential benefits adding AZD2811 might have to the current standard of care maintenance therapy of durvalumab in patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC) who have not had any treatment yet for their cancer.
- Conditions
- First-line patients with extensive disease small-cell lung cancer (SCLC)MedDRA version: 21.1Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-004091-18-ES
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
• Documented evidence of extensive stage SCLC (ES-SCLC)
• Participants must be considered suitable to receive a platinum-based chemotherapy regimen, combined with durvalumab, as first-line treatment for ES-SCLC
• No prior exposure to immune-mediated therapy
• Life expectancy =12 weeks at Day 1.
• ECOG 0 or 1 at enrolment.
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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
• Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy
• Has a paraneoplastic syndrome (PNS) of autoimmune systemic steroids or immunosuppressive agents) or has a clinical symptomatology suggesting worsening of PNS
• Active infection including tuberculosis, HIV, hepatitis B and C
• Active or prior documented autoimmune or inflammatory disorders
• Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method