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

AstraZeneca101 enrolled

Overview

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.

This trial will provide an opportunity to further evaluate the safety profile and efficacy of durvalumab + EP in patient population that is reflective of real-world clinical practice, Durvalumab will be concurrently administered with first-line chemotherapy (EP) on an every 3 week (q3w) schedule for 4 to 6 cycles, and will continue to be administered as monotherapy post-chemotherapy on an every 4 week (q4w) schedule until confirmed progressive disease (PD) or unacceptable toxicity. Prophylactic cranial irradiation (PCI) is allowed in patients showing complete or partial responses after the durvalumab + EP combination cycles, at the discretion of the investigator according to their local clinical practice.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

101

Conditions

Small Cell Lung Carcinoma Extensive Disease

Interventions

DurvalumabDRUG

Durvalumab 1500 mg via IV infusion over 60 minutes on Day 1 of each cycle.

CisplatinDRUG

Cisplatin as an IV infusion per local standards (usually over 60 to 120 minutes on Day 1) of each cycle.

EtoposideDRUG

Etoposide sequentially administered per local standards (usually over 30 to 60 minutes IV infusion) on Days 1, 2, and 3 of each cycle.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Research Site

A Coruña, Spain

Outcomes

Primary Outcomes

Number of Patients With Adverse Events (AEs) Grade ≥ 3

Patients with AEs grade ≥ 3 acording to NCI CTCAE v5.0

Time frame: During study treatment, until disease progression (median 6 months)

Number of Patients With Immune-mediated Adverse Events (imAE)

Patients with immune-mediated adverse events (imAE) per patient

Time frame: During study treatment, until disease progression (median 6 months)

Secondary Outcomes

Progression Free Survival (PFS).

PFS: Defined as the time from the first date of treatment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from investigational product or receives another anticancer therapy prior to progression. Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable assessment.

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

Objetive Response Rate (ORR)

Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) Criteria for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Time frame: At least every 12 weeks, up to 18 monts

Duration of Response (DoR)

DoR: Defined as the time from the date of first documented response per RECIST1.1 until the first date of documented progression per RECIST1.1 or death in the absence of disease progression.

Time frame: From the date of first documented response until the first date of documented progression or death in the absence of disease progression, assessed up to 2 years.

Data from ClinicalTrials.gov

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Carboplatin as an IV infusion per local standards (usually over 30 to 60 minutes on Day 1) of each cycle.

Research Site

Alicante, Spain

Research Site

Badajoz, Spain

Research Site

Badalona, Spain

Research Site

Barcelona, Spain

Research Site

Barcelona, Spain

Research Site

Barcelona, Spain

Research Site

Barcelona, Spain

Research Site

Castellon, Spain

Research Site

Córdoba, Spain

...and 24 more locations

Time to Treatment Discontinuation (TTD)

TTD: Defined as the time from the first date of treatment until the end of treatment date.

Time frame: From the first date of treatment until the end of treatment date, assessed up to 2 years.

Overal Survival (OS)

OS: Defined as the time from the first date of treatment until death due to any cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.

Time frame: From date of inclusion until the date of death, assessed up to 30 months

PFS Rate at 6 Months

Percentage of participants remaining alive without disease progression at 6 months after initiation of study treatment.

Time frame: Every 12 weeks

PFS Rate at 12 Months

Percentage of participants remaining alive without disease progression at 12 months after initiation of study treatment.

Time frame: Every 12 weeks

DoR Rate at 12 Months

Percentage of responders remaining alive without disease progression at 12 months after first response.

Time frame: Every 12 weeks

OS Rate at 6 Months

Percentage of participants remaining alive at 6 months after initiation of study treatment.

Time frame: Every 12 weeks

OS Rate at 12 Months

Percentage of participants remaining alive at 12 months after initiation of study treatment.

Time frame: Every 12 weeks

OS Rate at 18 Months

Percentage of participants remaining alive at 18 months after initiation of study treatment.

Time frame: Every 12 weeks

EORTC QLQ-C30: Global Health Status Domain, Change From Baseline to End of Treatment Visit

EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. Change from baseline is the difference in the score between the end of treatment visit and the first visit.