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

Sponsor

AstraZeneca (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04712903

Collaborator

(none)

101

Enrollment

Locations

Arm

24.5

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Small Cell Lung Carcinoma Extensive Disease	Drug: Durvalumab Drug: Cisplatin Drug: Etoposide Drug: Carboplatin	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

101 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Dec 16, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Durvalumab in Combination with Platinum-Etoposide Durvalumab 1500 mg via IV infusion 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 post-chemotherapy on an every 4 week (q4w) schedule until confirmed progressive disease (PD) or unacceptable toxicity.	Drug: Durvalumab Durvalumab 1500 mg via IV infusion over 60 minutes on Day 1 of each cycle. Drug: Cisplatin Cisplatin as an IV infusion per local standards (usually over 60 to 120 minutes on Day 1) of each cycle. Drug: Etoposide Etoposide sequentially administered per local standards (usually over 30 to 60 minutes IV infusion) on Days 1, 2, and 3 of each cycle. Drug: Carboplatin Carboplatin as an IV infusion per local standards (usually over 30 to 60 minutes on Day 1) of each cycle.

Arm

Intervention/Treatment

Experimental: Durvalumab in Combination with Platinum-Etoposide

Durvalumab 1500 mg via IV infusion 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 post-chemotherapy on an every 4 week (q4w) schedule until confirmed progressive disease (PD) or unacceptable toxicity.

Drug: Durvalumab

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

Drug: Cisplatin

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

Drug: Etoposide

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

Drug: Carboplatin

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

Outcome Measures

Primary Outcome Measures

Incidence of grade ≥ 3 Adverse Events (AE) [Up to 18 months]
Incidence of Immune Mediated Adverse Events (imAE). [Up to 18 months]

Secondary Outcome Measures

Progression Free Survival (PFS). [Up to 18 months]
PFS, defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first. PFS will be calculated based on disease status evaluated by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
PFS rate at 6 months (PFS6). [Up to 6 months]
PFS at 6 months, defined as the proportion of participants remaining alive without disease progression at 6 months after initiation of study treatment.
PFS rate at 1 year (PFS12). [Up to 12 months]
PFS at 1 year, defined as the proportion of participants remaining alive without disease progression at 1 year after initiation of study treatment.
Objective Response Rate (ORR): using site investigator assessments according to RECIST 1.1. [Up to 18 months]
ORR, defined as the percentage of patients who attain complete response (CR) or partial response (PR) according to RECIST v1.
Duration of Response (DoR). [Up to 18 months]
Duration of response (DOR), defined as the time from initial response to disease progression or death among patients who have experienced a CR or PR (unconfirmed) during the study. Duration of response will be calculated based on disease status evaluated by the investigator according to RECIST v1.1.
DoR rate at 1 year (DoR12) [Up to 12 months]
DoR at 1 year, defined as the proportion of participants having CR or PR (unconfirmed) at 1 year after initiation of study treatment.
Time to Treatment Discontinuation (TTD). [Up to 18 months]
Defined as the time in months between first and last study treatment dose.
Overal Survival (OS). [Up to 18 months]
OS, defined as the time from initiation of study treatment to death from any cause.
OS rate at 6 months. [Up to 6 months]
OS at 6 months, defined as the proportion of participants remaining alive at 6 months after initiation of study treatment.
OS rate at 1 year. [Up to 12 months]
OS at 1 year, defined as the proportion of participants remaining alive at 1 year after initiation of study treatment.
OS rate at 18 months. [Up to 18 months]
OS at 18 months, defined as the proportion of participants remaining alive at 18 months after initiation of study treatment.
Change from baseline in symptoms and quality of life as assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (EORTC QLQ-C30) and Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13). [Up to 18 months]
Changes from baseline in PRO-CTCAE. [Up to 18 months]
Number of visits to oncology service, emergency visits, outpatient visits, imaging tests and biopsy-related procedures and number and length of hospitalizations. [Up to 18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Research Site	A Coruna	Spain	15006
2	Research Site	Alicante	Spain	03010
3	Research Site	Badajoz	Spain	6006
4	Research Site	Barcelona	Spain	08036
5	Research Site	Barcelona	Spain	08908
6	Research Site	Barcelona	Spain	8003
7	Research Site	Barcelona	Spain	8907
8	Research Site	Barcelona	Spain	?08041
9	Research Site	Castellon de la Plana	Spain	12004
10	Research Site	Córdoba	Spain	14004
11	Research Site	Galdakao	Spain	48960
12	Research Site	Granada	Spain	18014
13	Research Site	Jaén	Spain	23007
14	Research Site	La Laguna	Spain	38320
15	Research Site	León	Spain	24071
16	Research Site	Madrid	Spain	28027
17	Research Site	Madrid	Spain	28034
18	Research Site	Madrid	Spain	28040
19	Research Site	Madrid	Spain	28041
20	Research Site	Majadahonda	Spain	28222
21	Research Site	Mataro	Spain	08304
22	Research Site	Murcia	Spain	30008
23	Research Site	Málaga	Spain	29011
24	Research Site	Ourense	Spain	32005
25	Research Site	Oviedo	Spain	33011
26	Research Site	Palma	Spain	07198
27	Research Site	Reus,Tarragona	Spain	43204
28	Research Site	San Sebastián	Spain	20014
29	Research Site	Santander	Spain	39008
30	Research Site	Santiago de Compostela	Spain	15706
31	Research Site	Toledo	Spain	45004
32	Research Site	Valencia	Spain	46026
33	Research Site	Valladolid	Spain	47003
34	Research Site	Zaragoza	Spain	50009