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Durvalumab Plus Chemotherapy in Untreated Patients With Extensive-Stage Small Cell Lung Cancer

CompletedPhase 3

Sponsor: AstraZeneca

Conditions: Small Cell Lung Carcinoma Extensive Disease

Interventions: Durvalumab, Cisplatin, Etoposide, Carboplatin

Countries: Spain

This is a Phase IIIb, interventional, single arm, multicentre study to evaluate safety, effectivenees, use of resources and patient reporting outcomes in patients with ES-SCLC treated with durvalumab in combination with platinum-etoposide as first-line treatment in Spain.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Histologically or cytologically documented Small cell Lung Cancer with extensive disease.
* Patients who had received chemoradiotherapy for LS-SCLC and have experienced a treatment-free interval of at least 6 months since last chemotherapy, radiotherapy, or chemoradiotherapy cycle, can be included under investigator criteria.
* Brain metastases; must be asymptomatic or have been treated at least 2 weeks prior to study treatment and are currently receiving 10 mg/day or less of prednisone or equivalent.
* Patients must be considered suitable to receive a platinum-based chemotherapy regimen as 1st line treatment for ES-SCLC.
* ECOG Performance Status of 0-2 at enrolment.
* No prior exposure to immune-mediated therapy for cancer.
* Adequate hematologic and organ function.
* Life expectancy of at least 12 weeks.
* Body weight \>30 kg.

Exclusion Criteria:

* Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy (except paliative care outside of the chest).
* Paraneoplastic syndrome of autoimmune nature, requiring systemic treatment or clinical symptomatology suggesting worsening of PNS
* Active infection including tuberculosis, HIV, hepatitis B anc C
* Active or prior documented autoimmune or inflammatory disorders
* Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.

Locations (34)

A Coruña, Spain
Alicante, Spain
Badajoz, Spain
Badalona, Spain
Barcelona, Spain
Barcelona, Spain
Barcelona, Spain
Barcelona, Spain
Castellon, Spain
Córdoba, Spain
Galdakao, Spain
Granada, Spain
Jaén, Spain
León, Spain
Madrid, Spain
Madrid, Spain
Madrid, Spain
Madrid, Spain
Majadahonda, Spain
Mataró, Spain
Málaga, Spain
Murcia, Spain
Ourense, Spain
Oviedo, Spain
Palma, Spain
Reus,Tarragona, Spain
San Cristóbal de La Laguna, Spain
San Sebastián, Spain
Santander, Spain
Santiago de Compostela, Spain
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