Clinical trial NCT04712903: Durvalumab Plus Chemotherapy in Untreated Patients With Extensive-Stage Small Cell Lung Cancer
Official title: A Phase IIIB, Single Arm Study, of Durvalumab in Combination With Platinum-Etoposide for Untreated Patients With Extensive-Stage Small Cell Lung Cancer Reflecting Real World Clinical Practice in Spain (CANTABRICO).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Small Cell Lung Carcinoma Extensive Disease
Keywords: Extensive-Stage
ICI
SCLC
Durvalumab
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-01-15
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Number of Patients With Adverse Events (AEs) Grade ≥ 3
timeFrame: During study treatment, until disease progression (median 6 months)
measure: Number of Patients With Immune-mediated Adverse Events (imAE)
timeFrame: During study treatment, until disease progression (median 6 months)
Secondary outcomes:
measure: Progression Free Survival (PFS).
timeFrame: 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
measure: Objetive Response Rate (ORR)
timeFrame: At least every 12 weeks, up to 18 monts
measure: Duration of Response (DoR)
timeFrame: 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.
measure: Time to Treatment Discontinuation (TTD)
timeFrame: From the first date of treatment until the end of treatment date, assessed up to 2 years.
measure: Overal Survival (OS)
timeFrame: From date of inclusion until the date of death, assessed up to 30 months
measure: PFS Rate at 6 Months
timeFrame: Every 12 weeks
measure: PFS Rate at 12 Months
timeFrame: Every 12 weeks
measure: DoR Rate at 12 Months
timeFrame: Every 12 weeks
measure: OS Rate at 6 Months
timeFrame: Every 12 weeks
measure: OS Rate at 12 Months
timeFrame: Every 12 weeks
measure: OS Rate at 18 Months
timeFrame: Every 12 weeks
measure: EORTC QLQ-C30: Global Health Status Domain, Change From Baseline to End of Treatment Visit
timeFrame: Baseline (cycle 1 day 1) and end of treatment visit.
measure: EORTC QLQ-C30: Physical Functioning Domain, Change From Baseline to End of Treatment Visit
timeFrame: Baseline (cycle 1 day 1) and end of treatment visit.
measure: EORTC QLQ-C30: Role Functioning Domain, Change From Baseline to End of Treatment Visit
timeFrame: Baseline (cycle 1 day 1) and end of treatment visit.
measure: EORTC QLQ-C30: Emotional Functioning Domain, Change From Baseline to End of Treatment Visit
timeFrame: Baseline (cycle 1 day 1) and end of treatment visit.
measure: EORTC QLQ-C30: Cognitive Functioning Domain, Change From Baseline to End of Treatment Visit
timeFrame: Baseline (cycle 1 day 1) and end of treatment visit.
measure: EORTC QLQ-C30: Social Functioning Domain, Change From Baseline to End of Treatment Visit
timeFrame: Baseline (cycle 1 day 1) and end of treatment visit.
measure: EORTC QLQ-C30: Fatigue, Change From Baseline to End of Treatment Visit
timeFrame: Baseline (cycle 1 day 1) and end of treatment visit.
measure: . EORTC QLQ-C30: Pain, Change From Baseline to End of Treatment Visit
timeFrame: Baseline (cycle 1 day 1) and end of treatment visit.
measure: EORTC QLQ-C30: Nausea and Vomiting, Change From Baseline to End of Treatment Visit
timeFrame: Baseline (cycle 1 day 1) and end of treatment visit.
measure: EORTC QLQ-C30: Dyspnoea, Change From Baseline to End of Treatment Visit
timeFrame: Baseline (cycle 1 day 1) and end of treatment visit.
measure: EORTC QLQ-C30: Insomnia, Change From Baseline to End of Treatment Visit
timeFrame: Baseline (cycle 1 day 1) and end of treatment visit.
measure: EORTC QLQ-C30: Appetite Loss, Change From Baseline to End of Treatment Visit
timeFrame: Baseline (cycle 1 day 1) and end of treatment visit.
measure: EORCT QLQ-C30: Constipation, Change From Baseline to End of Treatment Visit
timeFrame: Baseline (cycle 1 day 1) and end of treatment visit.
measure: EORTC QLQ-C30: Diarrhoea, Change From Baseline to End of Treatment Visit
timeFrame: Baseline (cycle 1 day 1) and end of treatment visit.
measure: EORTC QLQ-C30: Financial Difficulties, Change From Baseline to End of Treatment Visit
timeFrame: Baseline (cycle 1 day 1) and end of treatment visit.
measure: EORTC QLQ-LC13: Coughing, Change From Baseline to End of Treatment Visit
timeFrame: Baseline (cycle 1 day 1) and end of treatment visit.
measure: EORTC QLQ-LC13: Haemoptysis, Change From Baseline to End of Treatment Visit
timeFrame: Baseline (cycle 1 day 1) and end of treatment visit.
measure: EORTC QLQ-LC13: Dyspnoea, Change From Baseline to End of Treatment Visit
timeFrame: Baseline (cycle 1 day 1) and end of treatment visit.
measure: EORTC QLQ-LC13: Pain in Arm or Shoulder, Change From Baseline to End of Treatment Visit
timeFrame: Baseline (cycle 1 day 1) and end of treatment visit.
measure: EORTC QLQ-LC13: Pain in Other Parts, Change From Baseline to End of Treatment Visit
timeFrame: Baseline (cycle 1 day 1) and end of treatment visit.
measure: EORTC QLQ-LC13: Sore Mouth, Change From Baseline to End of Treatment Visit
timeFrame: Baseline (cycle 1 day 1) and end of treatment visit.
measure: EORTC QLQ-LC13: Peripheral Neuropathy, Change From Baseline to End of Treatment Visit
timeFrame: Baseline (cycle 1 day 1) and end of treatment visit.
measure: EORTC QLQ-LC13: Alopecia, Change From Baseline to End of Treatment Visit
timeFrame: Baseline (cycle 1 day 1) and end of treatment visit.
measure: EORTC QLQ-LC13: Dysphagia, Change From Baseline to End of Treatment Visit
timeFrame: Baseline (cycle 1 day 1) and end of treatment visit.
measure: EORTC QLQ-LC13: Chest Pain Item Change From Baseline to End of Treatment Visit
timeFrame: Baseline (cycle 1 day 1) and end of treatment visit.
Other outcomes:
Locations:
city: A Coruna
country: Spain
facility: Research Site
city: Alicante
country: Spain
facility: Research Site
city: Badajoz
country: Spain
facility: Research Site
city: Badalona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Castellon de la Plana
country: Spain
facility: Research Site
city: Córdoba
country: Spain
facility: Research Site
city: Galdakao
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Jaén
country: Spain
facility: Research Site
city: La Laguna
country: Spain
facility: Research Site
city: León
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Majadahonda
country: Spain
facility: Research Site
city: Mataro
country: Spain
facility: Research Site
city: Murcia
country: Spain
facility: Research Site
city: Málaga
country: Spain
facility: Research Site
city: Ourense
country: Spain
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
city: Palma
country: Spain
facility: Research Site
city: Reus,Tarragona
country: Spain
facility: Research Site
city: San Sebastián
country: Spain
facility: Research Site
city: Santander
country: Spain
facility: Research Site
city: Santiago de Compostela
country: Spain
facility: Research Site
city: Toledo
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Valladolid
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
Study officials:
affiliation: Hospital Clínico Lozano Blesa, Zaragoza
name: Dolores Isla, M.D.
role: PRINCIPAL_INVESTIGATOR
References: