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

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).

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.

Study Overview

• Status: Completed
• Conditions: Small Cell Lung Carcinoma Extensive Disease
• Intervention / Treatment: Drug: Durvalumab; Drug: Cisplatin; Drug: Etoposide; Drug: Carboplatin

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 Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • A Coruna, Spain, 15006
    • Research Site
  • Alicante, Spain, 03010
    • Research Site
  • Badajoz, Spain, 6006
    • Research Site
  • Badalona, Spain, 08916
    • Research Site
  • Barcelona, Spain, 08036
    • Research Site
  • Barcelona, Spain, ?08041
    • Research Site
  • Barcelona, Spain, 08908
    • Research Site
  • Barcelona, Spain, 8003
    • Research Site
  • Castellon de la Plana, Spain, 12004
    • Research Site
  • Córdoba, Spain, 14004
    • Research Site
  • Galdakao, Spain, 48960
    • Research Site
  • Granada, Spain, 18014
    • Research Site
  • Jaén, Spain, 23007
    • Research Site
  • La Laguna, Spain, 38320
    • Research Site
  • León, Spain, 24071
    • Research Site
  • Madrid, Spain, 28034
    • Research Site
  • Madrid, Spain, 28041
    • Research Site
  • Madrid, Spain, 28040
    • Research Site
  • Madrid, Spain, 28027
    • Research Site
  • Majadahonda, Spain, 28222
    • Research Site
  • Mataro, Spain, 08304
    • Research Site
  • Murcia, Spain, 30008
    • Research Site
  • Málaga, Spain, 29011
    • Research Site
  • Ourense, Spain, 32005
    • Research Site
  • Oviedo, Spain, 33011
    • Research Site
  • Palma, Spain, 07198
    • Research Site
  • Reus,Tarragona, Spain, 43204
    • Research Site
  • San Sebastián, Spain, 20014
    • Research Site
  • Santander, Spain, 39008
    • Research Site
  • Santiago de Compostela, Spain, 15706
    • Research Site
  • Toledo, Spain, 45004
    • Research Site
  • Valencia, Spain, 46026
    • Research Site
  • Valladolid, Spain, 47003
    • Research Site
  • Zaragoza, Spain, 50009
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Adverse Events (AEs) Grade ≥ 3	Patients with AEs grade ≥ 3 acording to NCI CTCAE v5.0	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	During study treatment, until disease progression (median 6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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.
Time to Treatment Discontinuation (TTD)	TTD: Defined as the time from the first date of treatment until the end of treatment date.	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.	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.	Every 12 weeks
PFS Rate at 12 Months	Percentage of participants remaining alive without disease progression at 12 months after initiation of study treatment.	Every 12 weeks
DoR Rate at 12 Months	Percentage of responders remaining alive without disease progression at 12 months after first response.	Every 12 weeks
OS Rate at 6 Months	Percentage of participants remaining alive at 6 months after initiation of study treatment.	Every 12 weeks
OS Rate at 12 Months	Percentage of participants remaining alive at 12 months after initiation of study treatment.	Every 12 weeks
OS Rate at 18 Months	Percentage of participants remaining alive at 18 months after initiation of study treatment.	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.	Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Physical Functioning 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.	Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Role Functioning 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.	Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Emotional Functioning 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.	Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Cognitive Functioning 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.	Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Social Functioning 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.	Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Fatigue, 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 (GHS) 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 the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit.	Baseline (cycle 1 day 1) and end of treatment visit.
. EORTC QLQ-C30: Pain, 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 (GHS) 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 the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit.	Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Nausea and Vomiting, 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 (GHS) 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 the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit.	Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Dyspnoea, 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 (GHS) 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 the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit.	Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Insomnia, 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 (GHS) 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 the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit.	Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Appetite Loss, 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 (GHS) 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 the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit.	Baseline (cycle 1 day 1) and end of treatment visit.
EORCT QLQ-C30: Constipation, 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 (GHS) 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 the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit.	Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Diarrhoea, 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 (GHS) 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 the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit.	Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Financial Difficulties, 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 (GHS) 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 the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit.	Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Coughing, Change From Baseline to End of Treatment Visit	EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit.	Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Haemoptysis, Change From Baseline to End of Treatment Visit	EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit.	Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Dyspnoea, Change From Baseline to End of Treatment Visit	EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit.	Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Pain in Arm or Shoulder, Change From Baseline to End of Treatment Visit	EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit.	Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Pain in Other Parts, Change From Baseline to End of Treatment Visit	EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit.	Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Sore Mouth, Change From Baseline to End of Treatment Visit	EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit.	Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Peripheral Neuropathy, Change From Baseline to End of Treatment Visit	EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit.	Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Alopecia, Change From Baseline to End of Treatment Visit	EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit.	Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Dysphagia, Change From Baseline to End of Treatment Visit	EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit.	Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Chest Pain Item Change From Baseline to End of Treatment Visit	EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit.	Baseline (cycle 1 day 1) and end of treatment visit.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Dolores Isla, M.D., Hospital Clínico Lozano Blesa, Zaragoza

Publications and helpful links

Helpful Links

• CSR Synopsis
• SAP
• Protocol

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2020
• Primary Completion (Actual): June 21, 2023
• Study Completion (Actual): June 21, 2023

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Durvalumab; SCLC; ICI; Extensive-Stage
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Small Cell Lung Carcinoma; Antineoplastic Agents, Immunological; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Topoisomerase Inhibitors; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Durvalumab; Etoposide; Carboplatin
• Other Study ID Numbers: D419QC00005; 2020-002328-35 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes