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

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).

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04712903

Acronym

CANTABRICO

Enrollment

101

Registered

2021-01-15

Start date

2020-12-16

Completion date

2023-06-21

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Cell Lung Carcinoma Extensive Disease

Keywords

Extensive-Stage, ICI, SCLC, Durvalumab

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.

Interventions

DRUGDurvalumab

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

DRUGCisplatin

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

DRUGEtoposide

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

DRUGCarboplatin

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Patients With Adverse Events (AEs) Grade ≥ 3	During study treatment, until disease progression (median 6 months)	Patients with AEs grade ≥ 3 acording to NCI CTCAE v5.0
Number of Patients With Immune-mediated Adverse Events (imAE)	During study treatment, until disease progression (median 6 months)	Patients with immune-mediated adverse events (imAE) per patient

Secondary

Measure	Time frame	Description
Duration of Response (DoR)	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.	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 to Treatment Discontinuation (TTD)	From the first date of treatment until the end of treatment date, assessed up to 2 years.	TTD: Defined as the time from the first date of treatment until the end of treatment date.
Overal Survival (OS)	From date of inclusion until the date of death, assessed up to 30 months	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.
PFS Rate at 6 Months	Every 12 weeks	Percentage of participants remaining alive without disease progression at 6 months after initiation of study treatment.
PFS Rate at 12 Months	Every 12 weeks	Percentage of participants remaining alive without disease progression at 12 months after initiation of study treatment.
DoR Rate at 12 Months	Every 12 weeks	Percentage of responders remaining alive without disease progression at 12 months after first response.
OS Rate at 6 Months	Every 12 weeks	Percentage of participants remaining alive at 6 months after initiation of study treatment.
OS Rate at 12 Months	Every 12 weeks	Percentage of participants remaining alive at 12 months after initiation of study treatment.
OS Rate at 18 Months	Every 12 weeks	Percentage of participants remaining alive at 18 months after initiation of study treatment.
EORTC QLQ-C30: Global Health Status Domain, Change From Baseline to End of Treatment Visit	Baseline (cycle 1 day 1) and 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.
EORTC QLQ-C30: Physical Functioning Domain, Change From Baseline to End of Treatment Visit	Baseline (cycle 1 day 1) and 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.
EORTC QLQ-C30: Role Functioning Domain, Change From Baseline to End of Treatment Visit	Baseline (cycle 1 day 1) and 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.
EORTC QLQ-C30: Emotional Functioning Domain, Change From Baseline to End of Treatment Visit	Baseline (cycle 1 day 1) and 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.
EORTC QLQ-C30: Cognitive Functioning Domain, Change From Baseline to End of Treatment Visit	Baseline (cycle 1 day 1) and 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.
EORTC QLQ-C30: Social Functioning Domain, Change From Baseline to End of Treatment Visit	Baseline (cycle 1 day 1) and 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.
EORTC QLQ-C30: Fatigue, Change From Baseline to End of Treatment Visit	Baseline (cycle 1 day 1) and 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.
. EORTC QLQ-C30: Pain, Change From Baseline to End of Treatment Visit	Baseline (cycle 1 day 1) and 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.
Progression Free Survival (PFS).	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	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.
EORTC QLQ-C30: Dyspnoea, Change From Baseline to End of Treatment Visit	Baseline (cycle 1 day 1) and 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.
EORTC QLQ-C30: Insomnia, Change From Baseline to End of Treatment Visit	Baseline (cycle 1 day 1) and 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.
EORTC QLQ-C30: Appetite Loss, Change From Baseline to End of Treatment Visit	Baseline (cycle 1 day 1) and 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.
EORCT QLQ-C30: Constipation, Change From Baseline to End of Treatment Visit	Baseline (cycle 1 day 1) and 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.
EORTC QLQ-C30: Diarrhoea, Change From Baseline to End of Treatment Visit	Baseline (cycle 1 day 1) and 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.
EORTC QLQ-C30: Financial Difficulties, Change From Baseline to End of Treatment Visit	Baseline (cycle 1 day 1) and 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.
EORTC QLQ-LC13: Coughing, Change From Baseline to End of Treatment Visit	Baseline (cycle 1 day 1) and 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.
EORTC QLQ-LC13: Haemoptysis, Change From Baseline to End of Treatment Visit	Baseline (cycle 1 day 1) and 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.
EORTC QLQ-LC13: Dyspnoea, Change From Baseline to End of Treatment Visit	Baseline (cycle 1 day 1) and 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.
EORTC QLQ-LC13: Pain in Arm or Shoulder, Change From Baseline to End of Treatment Visit	Baseline (cycle 1 day 1) and 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.
EORTC QLQ-LC13: Pain in Other Parts, Change From Baseline to End of Treatment Visit	Baseline (cycle 1 day 1) and 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.
EORTC QLQ-LC13: Sore Mouth, Change From Baseline to End of Treatment Visit	Baseline (cycle 1 day 1) and 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.
EORTC QLQ-LC13: Peripheral Neuropathy, Change From Baseline to End of Treatment Visit	Baseline (cycle 1 day 1) and 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.
EORTC QLQ-LC13: Alopecia, Change From Baseline to End of Treatment Visit	Baseline (cycle 1 day 1) and 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.
EORTC QLQ-LC13: Dysphagia, Change From Baseline to End of Treatment Visit	Baseline (cycle 1 day 1) and 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.
EORTC QLQ-LC13: Chest Pain Item Change From Baseline to End of Treatment Visit	Baseline (cycle 1 day 1) and 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.
EORTC QLQ-C30: Nausea and Vomiting, Change From Baseline to End of Treatment Visit	Baseline (cycle 1 day 1) and 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.
Objetive Response Rate (ORR)	At least every 12 weeks, up to 18 monts	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

Countries

Spain

Participant flow

Recruitment details

101 patients were included in the study have been analysed. All patients included in the analysis started treatment with chemotherapy and durvalumab and 81 of them started maintenance treatment with durvalumab.

Participants by arm

Arm	Count
Experimental Arm Received study intervention	101
Total	101

Baseline characteristics

Characteristic	Experimental Arm
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	57 Participants
Age, Categorical Between 18 and 65 years	44 Participants
Age, Continuous	66.2 Years STANDARD_DEVIATION 7.2
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	80 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Sex: Female, Male Female	33 Participants
Sex: Female, Male Male	68 Participants
Smoking status Current smoker	46 Participants
Smoking status Former smoker	53 Participants
Smoking status Not available	2 Participants
Weight	75.6 Kg STANDARD_DEVIATION 16.8

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	76 / 101
other Total, other adverse events	100 / 101
serious Total, serious adverse events	57 / 101

Outcome results

Primary

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)

Population: All patients who received at least one dose of study treatment.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Experimental Arm	Number of Patients With Adverse Events (AEs) Grade ≥ 3	Yes	77 Participants
Experimental Arm	Number of Patients With Adverse Events (AEs) Grade ≥ 3	No	24 Participants

Primary

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)

Population: All participants who received at least one dose of study treatment.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Experimental Arm	Number of Patients With Immune-mediated Adverse Events (imAE)	Yes	38 Participants
Experimental Arm	Number of Patients With Immune-mediated Adverse Events (imAE)	No	63 Participants

Secondary

DoR Rate at 12 Months

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

Time frame: Every 12 weeks

Population: Patients who achieved complete response or partial response.

Arm	Measure	Value (NUMBER)
Experimental Arm	DoR Rate at 12 Months	35.7 Percentage of patients

Secondary

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.

Population: Patients who achieved complete response or partial response.

Arm	Measure	Value (MEDIAN)
Experimental Arm	Duration of Response (DoR)	5.6 Months

Secondary

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.