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

• Status: Active, not recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Treatments: Carboplatin; Durvalumab; Etoposide

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.