Trial Outcomes & Findings for Study of Durvalumab in Combination With Platinum and Etoposide for the First Line Treatment of Patients With Extensive-stage Small Cell Lung Cancer (NCT NCT04774380)
NCT ID: NCT04774380
Last Updated: 2025-05-23
Results Overview
Incidence of Grade 3 or higher adverse events to evaluate safety and tolerability profile of durvalumab + Platinum (cisplatin or carboplatin) plus etoposide (EP) treatment was assessed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
152 participants
Primary outcome timeframe
From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
Results posted on
2025-05-23
Participant Flow
The study was conducted at 32 sites in 5 countries: Bulgaria, Czech Republic, Germany, Italy, Turkey. Study results are presented as of final data cut-off (DCO), 21Apr2024. After final DCO, no additional data was collected for the purpose of the analysis. Participants were allowed to continue the study drug until other drug supply options were available. The last subject's last visit was declared on 2Jan2025 once all participants were transferred to a rollover study or marketed product.
Participants who met all the inclusion and none of the exclusion criteria were enrolled in this study. All study assessments were performed as per the schedule of assessment.
Participant milestones
| Measure |
Durvalumab - (Cisplatin or Carboplatin) - Etoposide (Durvalumab +EP)
Participants received durvalumab 1500 mg administered via intravenous (IV) infusion concurrently with platinum-based chemotherapy and etoposide every 3 weeks (q3w) up to 6 cycles. Thereafter, durvalumab monotherapy was continued every 4 weeks post-chemotherapy unless specific treatment discontinuation criteria were met.
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|---|---|
|
Overall Study
STARTED
|
152
|
|
Overall Study
COMPLETED
|
152
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Durvalumab in Combination With Platinum and Etoposide for the First Line Treatment of Patients With Extensive-stage Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Durvalumab +EP
n=152 Participants
Participants received durvalumab 1500 mg administered IV infusion concurrently with platinum-based chemotherapy and etoposide every 3 weeks (q3w) up to 6 cycles. Thereafter, durvalumab monotherapy was continued every 4 weeks post-chemotherapy unless specific treatment discontinuation criteria were met.
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|---|---|
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Age, Continuous
|
64.0 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
151 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.Population: SAF which consisted of all enrolled patients who received at least 1 dose of any study treatment.
Incidence of Grade 3 or higher adverse events to evaluate safety and tolerability profile of durvalumab + Platinum (cisplatin or carboplatin) plus etoposide (EP) treatment was assessed.
Outcome measures
| Measure |
Durvalumab+EP
n=152 Participants
Participants received durvalumab 1500 mg via IV infusion concurrently with platinum-based chemotherapy and etoposide every 3 weeks (q3w) up to 6 weeks. Thereafter, durvalumab monotherapy was continued every 4 weeks post-chemotherapy unless specific treatment discontinuation criteria were met.
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|---|---|
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Number of Participants With Incidence of Grade 3 or Higher Adverse Events (AEs)
|
91 Participants
|
PRIMARY outcome
Timeframe: From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.Population: SAF which consisted of all enrolled patients who received at least 1 dose of any study treatment.
Immune mediated adverse events (imAEs) were assessed to evaluate safety and tolerability profile of durvalumab + EP treatment. An imAE is defined as an AESI that is associated with drug exposure and is consistent with an immune-mediated mechanism of action (MOA) and where there is no clear alternate etiology.
Outcome measures
| Measure |
Durvalumab+EP
n=152 Participants
Participants received durvalumab 1500 mg via IV infusion concurrently with platinum-based chemotherapy and etoposide every 3 weeks (q3w) up to 6 weeks. Thereafter, durvalumab monotherapy was continued every 4 weeks post-chemotherapy unless specific treatment discontinuation criteria were met.
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|---|---|
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Number of Participants With Incidence of Immune Mediated Adverse Events (imAEs)
|
22 Participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment until disease progression or death, up to 2.5 years.Population: SAF which consisted of all enrolled patients who received at least 1 dose of any study treatment.
Efficacy of durvalumab + EP treatment by evaluating PFS according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was assessed. The PFS is 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 participant withdrew from Investigational medicinal product (IMP) or received another anticancer therapy prior to progression.
Outcome measures
| Measure |
Durvalumab+EP
n=152 Participants
Participants received durvalumab 1500 mg via IV infusion concurrently with platinum-based chemotherapy and etoposide every 3 weeks (q3w) up to 6 weeks. Thereafter, durvalumab monotherapy was continued every 4 weeks post-chemotherapy unless specific treatment discontinuation criteria were met.
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|---|---|
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Progression-free Survival (PFS)
|
6.3 Months
Interval 5.75 to 6.47
|
SECONDARY outcome
Timeframe: From first date of study treatment until 12 months.Population: SAF which consisted of all enrolled patients who received at least 1 dose of any study treatment.
The efficacy of durvalumab + EP treatment by evaluating PFS12 according to RECIST 1.1 was assessed.
Outcome measures
| Measure |
Durvalumab+EP
n=152 Participants
Participants received durvalumab 1500 mg via IV infusion concurrently with platinum-based chemotherapy and etoposide every 3 weeks (q3w) up to 6 weeks. Thereafter, durvalumab monotherapy was continued every 4 weeks post-chemotherapy unless specific treatment discontinuation criteria were met.
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|---|---|
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Percentage of Participants Alive and Progression-free at 12 Months From First Date of Treatment (PFS12)
|
15.0 Percentage of participants
Interval 9.76 to 21.21
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SECONDARY outcome
Timeframe: From screening until disease progression or the last evaluable assessment in the absence of progression, up to 2.5 years.Population: SAF which consisted of all enrolled patients who received at least 1 dose of any study treatment.
The efficacy of durvalumab + EP treatment by evaluating ORR according to RECIST 1.1 was assessed. The ORR will be assessed based on Investigator-assessed response to treatment of complete response (CR) and partial response (PR), per RECIST1.1.
Outcome measures
| Measure |
Durvalumab+EP
n=152 Participants
Participants received durvalumab 1500 mg via IV infusion concurrently with platinum-based chemotherapy and etoposide every 3 weeks (q3w) up to 6 weeks. Thereafter, durvalumab monotherapy was continued every 4 weeks post-chemotherapy unless specific treatment discontinuation criteria were met.
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|---|---|
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Objective Response Rate (ORR)
|
66.4 Percentage of participants
Interval 58.3 to 73.9
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SECONDARY outcome
Timeframe: From the date of first documented response until the first date of documented progression or death in the absence of disease progression, up to 2.5 years.Population: SAF which consisted of all enrolled patients who received at least 1 dose of any study treatment.
The efficacy of durvalumab + EP treatment by evaluating DoR according to RECIST 1.1 was assessed. The DoR is 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.
Outcome measures
| Measure |
Durvalumab+EP
n=101 Participants
Participants received durvalumab 1500 mg via IV infusion concurrently with platinum-based chemotherapy and etoposide every 3 weeks (q3w) up to 6 weeks. Thereafter, durvalumab monotherapy was continued every 4 weeks post-chemotherapy unless specific treatment discontinuation criteria were met.
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|---|---|
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Duration of Response (DoR)
|
5.2 Months
Interval 5.03 to 5.59
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SECONDARY outcome
Timeframe: From the date of first documented response until the first date of documented progression or death in the absence of disease progression, up to 2.5 years.Population: SAF which consisted of all enrolled patients who received at least 1 dose of any study treatment.
The efficacy of durvalumab + EP treatment by evaluating DoR12 according to RECIST 1.1 was assessed.
Outcome measures
| Measure |
Durvalumab+EP
n=101 Participants
Participants received durvalumab 1500 mg via IV infusion concurrently with platinum-based chemotherapy and etoposide every 3 weeks (q3w) up to 6 weeks. Thereafter, durvalumab monotherapy was continued every 4 weeks post-chemotherapy unless specific treatment discontinuation criteria were met.
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|---|---|
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Percentage of Participants Remaining in Response, 12 Months After First Documented Objective Response (DoR12)
|
19.8 Percentage of participants
Interval 12.7 to 28.06
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SECONDARY outcome
Timeframe: From first dose of study treatment to death, up to 2.5 years.Population: SAF which consisted of all enrolled patients who received at least 1 dose of any study treatment.
Assessment of the efficacy of durvalumab + EP treatment by evaluating OS. The OS is the time from the first date of treatment until death due to any cause.
Outcome measures
| Measure |
Durvalumab+EP
n=152 Participants
Participants received durvalumab 1500 mg via IV infusion concurrently with platinum-based chemotherapy and etoposide every 3 weeks (q3w) up to 6 weeks. Thereafter, durvalumab monotherapy was continued every 4 weeks post-chemotherapy unless specific treatment discontinuation criteria were met.
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|---|---|
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Overall Survival (OS)
|
16.4 Months
Interval 12.45 to 18.73
|
SECONDARY outcome
Timeframe: From first dose of study treatment till 12 months.Population: SAF which consisted of all enrolled patients who received at least 1 dose of any study treatment.
The efficacy of durvalumab + EP treatment by evaluating OS12 was assessed.
Outcome measures
| Measure |
Durvalumab+EP
n=152 Participants
Participants received durvalumab 1500 mg via IV infusion concurrently with platinum-based chemotherapy and etoposide every 3 weeks (q3w) up to 6 weeks. Thereafter, durvalumab monotherapy was continued every 4 weeks post-chemotherapy unless specific treatment discontinuation criteria were met.
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|---|---|
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Percentage of Participants Alive at 12 Months From First Date of Treatment (OS12)
|
59.8 Percentage of participants
Interval 51.0 to 67.55
|
SECONDARY outcome
Timeframe: From first dose of study treatment until 90 days after discontinuation, up to 2.5 years.To evaluate safety and tolerability profile of durvalumab + EP treatment, adverse events and serious adverse events were assessed.
Outcome measures
| Measure |
Durvalumab+EP
n=152 Participants
Participants received durvalumab 1500 mg via IV infusion concurrently with platinum-based chemotherapy and etoposide every 3 weeks (q3w) up to 6 weeks. Thereafter, durvalumab monotherapy was continued every 4 weeks post-chemotherapy unless specific treatment discontinuation criteria were met.
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|---|---|
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Number of Participants With Adverse Events and Serious Adverse Events
Any SAE (including events with outcome of death)
|
52 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events
Any Adverse event (AE)
|
142 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events
Any AE possibly related to any treatment
|
109 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events
Any AE of maximum CTCAE grade 3 or grade 4
|
85 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events
Any AE of maximum CTCAE grade 3 or grade 4, possibly related to any treatment
|
59 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events
Any AE with outcome of death
|
15 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events
Any AE with outcome of death, possibly related to any treatment
|
4 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events
Any AE with outcome of death, possibly related to durvalumab
|
0 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events
Any AE with outcome of death, possibly related to EP
|
4 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events
Any SAE (including events with outcome of death), possibly related to any treatment
|
16 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events
Any AE leading to interruption or discontinuation of durvalumab
|
40 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events
Any AE leading to interruption or discontinuation of EP
|
41 Participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment until 90 days after discontinuation, up to 2.5 years.Population: SAF which consisted of all enrolled patients who received at least 1 dose of any study treatment.
To evaluate safety and tolerability profile of durvalumab + EP treatment, adverse events of special interests were assessed. An AESI is an AE of scientific and medical interest specific to understanding of the IMP. AESIs for durvalumab include, but are not limited to, events with a potential inflammatory or immune-mediated mechanism and which may require more frequent monitoring and/or interventions such as steroids, immunosuppressants, and/or hormone replacement therapy. This includes adverse events of special/ possible interest.
Outcome measures
| Measure |
Durvalumab+EP
n=152 Participants
Participants received durvalumab 1500 mg via IV infusion concurrently with platinum-based chemotherapy and etoposide every 3 weeks (q3w) up to 6 weeks. Thereafter, durvalumab monotherapy was continued every 4 weeks post-chemotherapy unless specific treatment discontinuation criteria were met.
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|---|---|
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Number of Participants With Adverse Events of Special Interests
|
82 Participants
|
Adverse Events
Durvalumab+EP
Serious events: 52 serious events
Other events: 136 other events
Deaths: 85 deaths
Serious adverse events
| Measure |
Durvalumab+EP
n=152 participants at risk
Participants received durvalumab 1500 mg via IV infusion concurrently with platinum-based chemotherapy and etoposide every 3 weeks (q3w) up to 6 weeks. Thereafter, durvalumab monotherapy was continued every 4 weeks post-chemotherapy unless specific treatment discontinuation criteria were met.
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|---|---|
|
Infections and infestations
Abdominal infection
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Infections and infestations
Pneumonia
|
5.9%
9/152 • Number of events 9 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Infections and infestations
Postoperative wound infection
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Infections and infestations
Sepsis
|
1.3%
2/152 • Number of events 2 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Infections and infestations
Tooth abscess
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
3/152 • Number of events 3 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.3%
2/152 • Number of events 2 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.0%
3/152 • Number of events 3 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.3%
2/152 • Number of events 2 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.0%
3/152 • Number of events 3 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.66%
1/152 • Number of events 2 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.6%
4/152 • Number of events 4 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Nervous system disorders
Brain oedema
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Nervous system disorders
Syncope
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Cardiac disorders
Atrial fibrillation
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Vascular disorders
Embolism arterial
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Vascular disorders
Hypertension
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Vascular disorders
Peripheral ischaemia
|
0.66%
1/152 • Number of events 2 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
2/152 • Number of events 2 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.3%
2/152 • Number of events 2 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.66%
1/152 • Number of events 3 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
3/152 • Number of events 3 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Gastrointestinal disorders
Constipation
|
1.3%
2/152 • Number of events 2 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Gastrointestinal disorders
Haematemesis
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Gastrointestinal disorders
Ileus
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Gastrointestinal disorders
Vomiting
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Hepatobiliary disorders
Cholestasis
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Hepatobiliary disorders
Jaundice
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Skin and subcutaneous tissue disorders
Cellulite
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.6%
4/152 • Number of events 5 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
General disorders
Death
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
General disorders
Swelling
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Investigations
Alanine aminotransferase increased
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Investigations
Aspartate aminotransferase increased
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Investigations
Blood creatinine increased
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Investigations
Lymphocyte count decreased
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Investigations
Neutrophil count decreased
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Investigations
Platelet count decreased
|
2.0%
3/152 • Number of events 3 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Investigations
Urine output decreased
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Nervous system disorders
Immune-mediated encephalopathy
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Nervous system disorders
Status epilepticus
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Eye disorders
Vision blurred
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Hepatobiliary disorders
Suspected drug-induced liver injury
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Surgical and medical procedures
Intestinal anastomosis
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Infections and infestations
Appendicitis
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.66%
1/152 • Number of events 1 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
Other adverse events
| Measure |
Durvalumab+EP
n=152 participants at risk
Participants received durvalumab 1500 mg via IV infusion concurrently with platinum-based chemotherapy and etoposide every 3 weeks (q3w) up to 6 weeks. Thereafter, durvalumab monotherapy was continued every 4 weeks post-chemotherapy unless specific treatment discontinuation criteria were met.
|
|---|---|
|
Infections and infestations
COVID-19
|
6.6%
10/152 • Number of events 10 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.6%
13/152 • Number of events 16 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Blood and lymphatic system disorders
Anaemia
|
55.9%
85/152 • Number of events 117 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
4.6%
7/152 • Number of events 8 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.5%
19/152 • Number of events 30 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.6%
51/152 • Number of events 91 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
15.8%
24/152 • Number of events 44 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Endocrine disorders
Hyperthyroidism
|
11.8%
18/152 • Number of events 28 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Endocrine disorders
Hypothyroidism
|
11.8%
18/152 • Number of events 22 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.6%
13/152 • Number of events 13 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
3.3%
5/152 • Number of events 5 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.6%
10/152 • Number of events 13 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.3%
8/152 • Number of events 9 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.6%
10/152 • Number of events 12 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.5%
19/152 • Number of events 24 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.9%
15/152 • Number of events 21 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Nervous system disorders
Dizziness
|
5.3%
8/152 • Number of events 8 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Nervous system disorders
Headache
|
7.2%
11/152 • Number of events 13 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Nervous system disorders
Neuropathy peripheral
|
3.9%
6/152 • Number of events 6 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.6%
7/152 • Number of events 7 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Vascular disorders
Hypotension
|
3.3%
5/152 • Number of events 5 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.9%
15/152 • Number of events 16 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.6%
13/152 • Number of events 13 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.9%
6/152 • Number of events 6 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.6%
7/152 • Number of events 8 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Gastrointestinal disorders
Constipation
|
19.7%
30/152 • Number of events 35 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.6%
13/152 • Number of events 18 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
9/152 • Number of events 9 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Gastrointestinal disorders
Nausea
|
24.3%
37/152 • Number of events 56 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Gastrointestinal disorders
Stomatitis
|
5.3%
8/152 • Number of events 9 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
8/152 • Number of events 10 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.2%
20/152 • Number of events 20 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.9%
6/152 • Number of events 6 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.6%
10/152 • Number of events 11 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.6%
7/152 • Number of events 7 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
5/152 • Number of events 6 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
General disorders
Asthenia
|
6.6%
10/152 • Number of events 11 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
General disorders
Fatigue
|
15.8%
24/152 • Number of events 29 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
General disorders
Oedema peripheral
|
3.9%
6/152 • Number of events 7 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
General disorders
Pyrexia
|
7.9%
12/152 • Number of events 13 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Investigations
Alanine aminotransferase increased
|
7.9%
12/152 • Number of events 14 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Investigations
Amylase increased
|
5.9%
9/152 • Number of events 9 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Investigations
Aspartate aminotransferase increased
|
9.2%
14/152 • Number of events 18 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.6%
10/152 • Number of events 13 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Investigations
Blood creatinine increased
|
11.8%
18/152 • Number of events 25 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.9%
9/152 • Number of events 10 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Investigations
Gamma-glutamyltransferase increased
|
9.9%
15/152 • Number of events 17 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Investigations
Lipase increased
|
3.9%
6/152 • Number of events 6 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Investigations
Neutrophil count decreased
|
9.9%
15/152 • Number of events 24 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Investigations
Platelet count decreased
|
7.9%
12/152 • Number of events 19 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Investigations
Weight decreased
|
5.3%
8/152 • Number of events 9 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Investigations
White blood cell count decreased
|
10.5%
16/152 • Number of events 25 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
3.3%
5/152 • Number of events 5 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.3%
5/152 • Number of events 6 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.3%
5/152 • Number of events 6 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Psychiatric disorders
Depression
|
3.3%
5/152 • Number of events 5 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
3.3%
5/152 • Number of events 6 • From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee This document contains trade secrets and confidential commercial information, disclosure of which is prohibited without providing advance notice to AstraZeneca and opportunity to object.
- Publication restrictions are in place
Restriction type: OTHER