Trial Outcomes & Findings for Durvalumab Plus Chemotherapy in ES-SCLC (Oriental) (NCT NCT04449861)
NCT ID: NCT04449861
Last Updated: 2024-11-27
Results Overview
COMPLETED
PHASE3
166 participants
19 months
2024-11-27
Participant Flow
The study recruited the first participant on 07 December 2020 and the last participant's last visit was completed on 30 March 2023. A total of 193 participants were screened, among which, 166 participants (86.0%) were successfully enrolled into the study from 32 study sites in China
Among the 166 enrolled participants, 165 of them (99.4%) received the study treatment, while only 1 participant (0.6%) did not receive the study treatment. All subjects who received at least 1 dose of study treatment will be included in the safety analysis set, which will be the primary analysis set for all analyses.
Participant milestones
| Measure |
Durvalumab With EP
durvalumab + etoposide and cisplatin or carboplatin
|
|---|---|
|
Overall Study
STARTED
|
166
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
121
|
Reasons for withdrawal
| Measure |
Durvalumab With EP
durvalumab + etoposide and cisplatin or carboplatin
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Death
|
112
|
Baseline Characteristics
Durvalumab Plus Chemotherapy in ES-SCLC (Oriental)
Baseline characteristics by cohort
| Measure |
Durvalumab With EP
n=165 Participants
durvalumab + etoposide and cisplatin or carboplatin
|
|---|---|
|
Age, Continuous
Age (years)
|
63.70 years
STANDARD_DEVIATION 7.699 • n=5 Participants
|
|
Sex: Female, Male
Sex · Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Sex · Male
|
140 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
165 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
165 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 19 monthsPopulation: 165 subjects who received at least 1 dose of study treatment are included in the analysis.
Outcome measures
| Measure |
Durvalumab With EP
n=165 Participants
durvalumab + etoposide and cisplatin or carboplatin
|
|---|---|
|
Percentage of Participants With Grade ≥3 AEs
|
49.7 percentage of participants
|
PRIMARY outcome
Timeframe: 19 monthsPopulation: 165 subjects who received at least 1 dose of study treatment are included in the analysis.
An immune-mediated adverse event (imAE) is defined as an AESI that is associated with drug exposure and is consistent with an immune-mediated mechanism of action and where there is no clear alternate aetiology.
Outcome measures
| Measure |
Durvalumab With EP
n=165 Participants
durvalumab + etoposide and cisplatin or carboplatin
|
|---|---|
|
Percentage of Participants With Immune-mediated Adverse Events (imAEs)
|
24.2 percentage of participants
|
SECONDARY outcome
Timeframe: 19 monthsPopulation: 165 subjects who received at least 1 dose of study treatment are included in the analysis.
PFS by investigator assessment according to RECIST v1.1 criteria Progression-free survival is defined as the time from first dose of study 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 study therapy or receives another anti-cancer 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 of investigator. However, if the patient progresses or dies after 2 or more missed visits, the patient will be censored at the time of the latest assessment. If the patient has no evaluable visits or does not have baseline data, they will be censored at the day of first dose unless they die within 2 visits of baseline.
Outcome measures
| Measure |
Durvalumab With EP
n=165 Participants
durvalumab + etoposide and cisplatin or carboplatin
|
|---|---|
|
Median Progression Free Survival (PFS)
|
6.3 months
Interval 5.6 to 6.5
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 165 subjects who received at least 1 dose of study treatment are included in the analysis.
The APF12 is defined as the Kaplan-Meier estimate of PFS (per investigator assessment according to RECIST v1.1 criteria) at 12 months.
Outcome measures
| Measure |
Durvalumab With EP
n=165 Participants
durvalumab + etoposide and cisplatin or carboplatin
|
|---|---|
|
Proportion of Patients Alive and Progression Free at 12 Months (APF12)
|
17.6 percentage of participants
Interval 12.0 to 24.1
|
SECONDARY outcome
Timeframe: 19 monthsPopulation: 165 subjects who received at least 1 dose of study treatment are included in the analysis.
Objective Response Rate is defined as the number (%) of patients with measurable disease with at least 1 visit response of CR or PR. Data obtained up until progression or last evaluable assessment in the absence of progression will be included in the assessment of ORR. Any CR or PR which occurred after a further anti-cancer therapy was received will not be included in the numerator for the ORR calculation.
Outcome measures
| Measure |
Durvalumab With EP
n=165 Participants
durvalumab + etoposide and cisplatin or carboplatin
|
|---|---|
|
Objective Response Rate (ORR)
|
76.4 percentage of participants
Interval 69.1 to 82.6
|
SECONDARY outcome
Timeframe: 19 monthsPopulation: 165 subjects who received at least 1 dose of study treatment are included in the analysis.
Overall survival is defined as the time from the date of first dose of study 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.
Outcome measures
| Measure |
Durvalumab With EP
n=165 Participants
durvalumab + etoposide and cisplatin or carboplatin
|
|---|---|
|
Median Overall Survival (OS)
|
14.8 months
Interval 13.2 to 16.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 165 subjects who received at least 1 dose of study treatment are included in the analysis.
The OS12 is defined as the Kaplan-Meier estimate of OS at 12 months
Outcome measures
| Measure |
Durvalumab With EP
n=165 Participants
durvalumab + etoposide and cisplatin or carboplatin
|
|---|---|
|
Proportion of Patients Alive at 12 Months (OS12)
|
60.8 percentage of participants
Interval 52.8 to 67.9
|
SECONDARY outcome
Timeframe: 19 monthsPopulation: Duration of response is only calculated for patients who have a best overall tumor response of CR or PR before further anti-cancer therapy after first dose.
Duration of response is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression. The end of response should coincide with the date of progression or death from any cause used for the PFS endpoint. The time of the initial response will be defined as the latest of the dates contributing towards the first visit response of PR or CR.
Outcome measures
| Measure |
Durvalumab With EP
n=126 Participants
durvalumab + etoposide and cisplatin or carboplatin
|
|---|---|
|
Duration of Response (DOR)
|
5.1 months
Interval 4.7 to 5.7
|
SECONDARY outcome
Timeframe: 19 monthsPopulation: 165 subjects who received at least 1 dose of study treatment are included in the analysis.
Outcome measures
| Measure |
Durvalumab With EP
n=165 Participants
durvalumab + etoposide and cisplatin or carboplatin
|
|---|---|
|
Percentage of Participants With AEs
|
97.6 percentage of participants
|
SECONDARY outcome
Timeframe: 19 monthsPopulation: 165 subjects who received at least 1 dose of study treatment are included in the analysis.
Outcome measures
| Measure |
Durvalumab With EP
n=165 Participants
durvalumab + etoposide and cisplatin or carboplatin
|
|---|---|
|
Percentage of Participants With SAEs
|
42.4 percentage of participants
|
SECONDARY outcome
Timeframe: 19 monthsPopulation: 165 subjects who received at least 1 dose of study treatment are included in the analysis.
Outcome measures
| Measure |
Durvalumab With EP
n=165 Participants
durvalumab + etoposide and cisplatin or carboplatin
|
|---|---|
|
Percentage of Participants With Adverse Events of Special Interest (AESI)
|
40.0 percentage of participants
|
SECONDARY outcome
Timeframe: 19 monthsPopulation: 165 subjects who received at least 1 dose of study treatment are included in the analysis.
Outcome measures
| Measure |
Durvalumab With EP
n=165 Participants
durvalumab + etoposide and cisplatin or carboplatin
|
|---|---|
|
Percentage of Participants With AEs Resulting in Treatment Discontinuation
|
12.1 percentage of participants
|
Adverse Events
Durvalumab With EP
Serious adverse events
| Measure |
Durvalumab With EP
n=165 participants at risk
durvalumab + etoposide and cisplatin or carboplatin
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.1%
15/165 • Number of events 16 • 19 months
|
|
Blood and lymphatic system disorders
Myelosuppression
|
4.8%
8/165 • Number of events 8 • 19 months
|
|
Investigations
Platelet count decreased
|
8.5%
14/165 • Number of events 19 • 19 months
|
|
Investigations
Neutrophil count decreased
|
3.6%
6/165 • Number of events 6 • 19 months
|
|
Investigations
White blood cell count decreased
|
3.6%
6/165 • Number of events 7 • 19 months
|
|
Infections and infestations
Pneumonia
|
4.2%
7/165 • Number of events 7 • 19 months
|
|
Infections and infestations
Urinary tract infection
|
1.2%
2/165 • Number of events 3 • 19 months
|
|
Nervous system disorders
Cerebral infarction
|
1.2%
2/165 • Number of events 2 • 19 months
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
1.8%
3/165 • Number of events 3 • 19 months
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.2%
2/165 • Number of events 2 • 19 months
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
1.2%
2/165 • Number of events 2 • 19 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
2/165 • Number of events 2 • 19 months
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Investigations
Alanine aminotransferase increased
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
General disorders
Death
|
1.8%
3/165 • Number of events 3 • 19 months
|
|
General disorders
Pyrexia
|
1.2%
2/165 • Number of events 2 • 19 months
|
|
General disorders
Oedema peripheral
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Infections and infestations
Device related infection
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Infections and infestations
Febrile infection
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Infections and infestations
Gastroenteritis
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Infections and infestations
Hepatitis E
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Nervous system disorders
Epilepsy
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Nervous system disorders
Immune-mediated encephalitis
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Nervous system disorders
Lacunar infarction
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Nervous system disorders
Syncope
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Gastrointestinal disorders
Constipation
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Hepatobiliary disorders
Immune-mediated hepatic disorder
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Hepatobiliary disorders
Liver injury
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Vascular disorders
Aortic dissection
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Vascular disorders
Jugular vein thrombosis
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Vascular disorders
Superior vena cava occlusion
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Cardiac disorders
Arrhythmia
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Cardiac disorders
Pericardial effusion
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Endocrine disorders
Hyperthyroidism
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Endocrine disorders
Immune-mediated endocrinopathy
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Renal and urinary disorders
Immune-mediated nephritis
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Ear and labyrinth disorders
Otolithiasis
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Psychiatric disorders
Mania
|
0.61%
1/165 • Number of events 1 • 19 months
|
|
Infections and infestations
Infectious pleural effusion
|
0.61%
1/165 • Number of events 1 • 19 months
|
Other adverse events
| Measure |
Durvalumab With EP
n=165 participants at risk
durvalumab + etoposide and cisplatin or carboplatin
|
|---|---|
|
Blood and lymphatic system disorders
anaemia
|
75.8%
125/165 • Number of events 214 • 19 months
|
|
Gastrointestinal disorders
nausea
|
27.3%
45/165 • Number of events 77 • 19 months
|
|
Gastrointestinal disorders
vomiting
|
21.8%
36/165 • Number of events 64 • 19 months
|
|
Skin and subcutaneous tissue disorders
alopecia
|
21.8%
36/165 • Number of events 36 • 19 months
|
|
Gastrointestinal disorders
constipation
|
21.2%
35/165 • Number of events 49 • 19 months
|
|
Metabolism and nutrition disorders
decreased appetite
|
20.6%
34/165 • Number of events 51 • 19 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place