Trial Outcomes & Findings for Durvalumab Plus Chemotherapy in Untreated Patients With Extensive-Stage Small Cell Lung Cancer (NCT NCT04712903)
NCT ID: NCT04712903
Last Updated: 2025-01-07
Results Overview
Patients with AEs grade ≥ 3 acording to NCI CTCAE v5.0
COMPLETED
PHASE3
101 participants
During study treatment, until disease progression (median 6 months)
2025-01-07
Participant Flow
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.
Participant milestones
| Measure |
Experimental Arm
Received study intervention
|
|---|---|
|
Overall Study
STARTED
|
101
|
|
Overall Study
COMPLETED
|
101
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Durvalumab Plus Chemotherapy in Untreated Patients With Extensive-Stage Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Experimental Arm
n=101 Participants
Received study intervention
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
57 Participants
n=5 Participants
|
|
Age, Continuous
|
66.2 Years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
80 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Weight
|
75.6 Kg
STANDARD_DEVIATION 16.8 • n=5 Participants
|
|
Smoking status
Current smoker
|
46 Participants
n=5 Participants
|
|
Smoking status
Former smoker
|
53 Participants
n=5 Participants
|
|
Smoking status
Not available
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During study treatment, until disease progression (median 6 months)Population: All patients who received at least one dose of study treatment.
Patients with AEs grade ≥ 3 acording to NCI CTCAE v5.0
Outcome measures
| Measure |
Experimental Arm
n=101 Participants
Received study intervention
|
|---|---|
|
Number of Patients With Adverse Events (AEs) Grade ≥ 3
Yes
|
77 Participants
|
|
Number of Patients With Adverse Events (AEs) Grade ≥ 3
No
|
24 Participants
|
PRIMARY outcome
Timeframe: During study treatment, until disease progression (median 6 months)Population: All participants who received at least one dose of study treatment.
Patients with immune-mediated adverse events (imAE) per patient
Outcome measures
| Measure |
Experimental Arm
n=101 Participants
Received study intervention
|
|---|---|
|
Number of Patients With Immune-mediated Adverse Events (imAE)
Yes
|
38 Participants
|
|
Number of Patients With Immune-mediated Adverse Events (imAE)
No
|
63 Participants
|
SECONDARY outcome
Timeframe: 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 yearsPFS: 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.
Outcome measures
| Measure |
Experimental Arm
n=101 Participants
Received study intervention
|
|---|---|
|
Progression Free Survival (PFS).
|
6.1 Months
Interval 5.2 to 6.9
|
SECONDARY outcome
Timeframe: At least every 12 weeks, up to 18 montsPer 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
Outcome measures
| Measure |
Experimental Arm
n=101 Participants
Received study intervention
|
|---|---|
|
Objetive Response Rate (ORR)
|
54.5 Percentage of patients
Interval 44.7 to 64.2
|
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, assessed up to 2 years.Population: Patients who achieved complete response or partial response.
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.
Outcome measures
| Measure |
Experimental Arm
n=55 Participants
Received study intervention
|
|---|---|
|
Duration of Response (DoR)
|
5.6 Months
Interval 4.7 to 6.5
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental Arm
n=101 Participants
Received study intervention
|
|---|---|
|
Time to Treatment Discontinuation (TTD)
|
6.2 Months
Interval 4.5 to 9.9
|
SECONDARY outcome
Timeframe: From date of inclusion until the date of death, assessed up to 30 monthsOS: 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.
Outcome measures
| Measure |
Experimental Arm
n=101 Participants
Received study intervention
|
|---|---|
|
Overal Survival (OS)
|
9.6 Months
Interval 7.8 to 11.3
|
SECONDARY outcome
Timeframe: Every 12 weeksPercentage of participants remaining alive without disease progression at 6 months after initiation of study treatment.
Outcome measures
| Measure |
Experimental Arm
n=101 Participants
Received study intervention
|
|---|---|
|
PFS Rate at 6 Months
|
53.0 Percentage of patients
Interval 43.2 to 62.8
|
SECONDARY outcome
Timeframe: Every 12 weeksPercentage of participants remaining alive without disease progression at 12 months after initiation of study treatment.
Outcome measures
| Measure |
Experimental Arm
n=101 Participants
Received study intervention
|
|---|---|
|
PFS Rate at 12 Months
|
21.0 Percentage of patients
Interval 13.0 to 29.0
|
SECONDARY outcome
Timeframe: Every 12 weeksPopulation: Patients who achieved complete response or partial response.
Percentage of responders remaining alive without disease progression at 12 months after first response.
Outcome measures
| Measure |
Experimental Arm
n=55 Participants
Received study intervention
|
|---|---|
|
DoR Rate at 12 Months
|
35.7 Percentage of patients
Interval 23.0 to 48.4
|
SECONDARY outcome
Timeframe: Every 12 weeksPercentage of participants remaining alive at 6 months after initiation of study treatment.
Outcome measures
| Measure |
Experimental Arm
n=101 Participants
Received study intervention
|
|---|---|
|
OS Rate at 6 Months
|
75.2 Percentage of patients
Interval 66.8 to 83.6
|
SECONDARY outcome
Timeframe: Every 12 weeksPercentage of participants remaining alive at 12 months after initiation of study treatment.
Outcome measures
| Measure |
Experimental Arm
n=101 Participants
Received study intervention
|
|---|---|
|
OS Rate at 12 Months
|
40.7 Percentage of patients
Interval 31.1 to 50.3
|
SECONDARY outcome
Timeframe: Every 12 weeksPercentage of participants remaining alive at 18 months after initiation of study treatment.
Outcome measures
| Measure |
Experimental Arm
n=101 Participants
Received study intervention
|
|---|---|
|
OS Rate at 18 Months
|
31.6 Percentage of patients
Interval 22.4 to 40.8
|
SECONDARY outcome
Timeframe: Baseline (cycle 1 day 1) and end of treatment visit.Population: Enrolled participants who completed baseline and end of treatment questionnaires.
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.
Outcome measures
| Measure |
Experimental Arm
n=67 Participants
Received study intervention
|
|---|---|
|
EORTC QLQ-C30: Global Health Status Domain, Change From Baseline to End of Treatment Visit
|
-6.3 Units on a scale
Standard Deviation 30.8
|
SECONDARY outcome
Timeframe: Baseline (cycle 1 day 1) and end of treatment visit.Population: Enrolled participants who completed baseline and end of treatment questionnaires.
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.
Outcome measures
| Measure |
Experimental Arm
n=69 Participants
Received study intervention
|
|---|---|
|
EORTC QLQ-C30: Physical Functioning Domain, Change From Baseline to End of Treatment Visit
|
-15.0 Units on a scale
Standard Deviation 29.4
|
SECONDARY outcome
Timeframe: Baseline (cycle 1 day 1) and end of treatment visit.Population: Enrolled participants who completed baseline and end of treatment questionnaires.
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.
Outcome measures
| Measure |
Experimental Arm
n=69 Participants
Received study intervention
|
|---|---|
|
EORTC QLQ-C30: Role Functioning Domain, Change From Baseline to End of Treatment Visit
|
-17.0 Units on a scale
Standard Deviation 36.0
|
SECONDARY outcome
Timeframe: Baseline (cycle 1 day 1) and end of treatment visit.Population: Enrolled participants who completed baseline and end of treatment questionnaires.
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.
Outcome measures
| Measure |
Experimental Arm
n=69 Participants
Received study intervention
|
|---|---|
|
EORTC QLQ-C30: Emotional Functioning Domain, Change From Baseline to End of Treatment Visit
|
-2.3 Units on a scale
Standard Deviation 30.4
|
SECONDARY outcome
Timeframe: Baseline (cycle 1 day 1) and end of treatment visit.Population: Enrolled participants who completed baseline and end of treatment questionnaires.
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.
Outcome measures
| Measure |
Experimental Arm
n=69 Participants
Received study intervention
|
|---|---|
|
EORTC QLQ-C30: Cognitive Functioning Domain, Change From Baseline to End of Treatment Visit
|
-15.0 Units on a scale
Standard Deviation 24.0
|
SECONDARY outcome
Timeframe: Baseline (cycle 1 day 1) and end of treatment visit.Population: Enrolled participants who completed baseline and end of treatment questionnaires.
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.
Outcome measures
| Measure |
Experimental Arm
n=67 Participants
Received study intervention
|
|---|---|
|
EORTC QLQ-C30: Social Functioning Domain, Change From Baseline to End of Treatment Visit
|
-12.0 Units on a scale
Standard Deviation 31.0
|
SECONDARY outcome
Timeframe: Baseline (cycle 1 day 1) and end of treatment visit.Population: Enrolled participants who completed baseline and end of treatment questionnaires.
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.
Outcome measures
| Measure |
Experimental Arm
n=69 Participants
Received study intervention
|
|---|---|
|
EORTC QLQ-C30: Fatigue, Change From Baseline to End of Treatment Visit
|
12.4 Units on a scale
Standard Deviation 29.4
|
SECONDARY outcome
Timeframe: Baseline (cycle 1 day 1) and end of treatment visit.Population: Enrolled participants who completed baseline and end of treatment questionnaires.
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.
Outcome measures
| Measure |
Experimental Arm
n=69 Participants
Received study intervention
|
|---|---|
|
. EORTC QLQ-C30: Pain, Change From Baseline to End of Treatment Visit
|
0.2 Units on a scale
Standard Deviation 29.2
|
SECONDARY outcome
Timeframe: Baseline (cycle 1 day 1) and end of treatment visit.Population: Enrolled participants who completed baseline and end of treatment questionnaires.
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.
Outcome measures
| Measure |
Experimental Arm
n=69 Participants
Received study intervention
|
|---|---|
|
EORTC QLQ-C30: Nausea and Vomiting, Change From Baseline to End of Treatment Visit
|
0.7 Units on a scale
Standard Deviation 20.1
|
SECONDARY outcome
Timeframe: Baseline (cycle 1 day 1) and end of treatment visit.Population: Enrolled participants who completed baseline and end of treatment questionnaires.
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.
Outcome measures
| Measure |
Experimental Arm
n=69 Participants
Received study intervention
|
|---|---|
|
EORTC QLQ-C30: Dyspnoea, Change From Baseline to End of Treatment Visit
|
-2.4 Units on a scale
Standard Deviation 37.2
|
SECONDARY outcome
Timeframe: Baseline (cycle 1 day 1) and end of treatment visit.Population: Enrolled participants who completed baseline and end of treatment questionnaires.
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.
Outcome measures
| Measure |
Experimental Arm
n=68 Participants
Received study intervention
|
|---|---|
|
EORTC QLQ-C30: Insomnia, Change From Baseline to End of Treatment Visit
|
1.0 Units on a scale
Standard Deviation 36.4
|
SECONDARY outcome
Timeframe: Baseline (cycle 1 day 1) and end of treatment visit.Population: Enrolled participants who completed baseline and end of treatment questionnaires.
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.
Outcome measures
| Measure |
Experimental Arm
n=69 Participants
Received study intervention
|
|---|---|
|
EORTC QLQ-C30: Appetite Loss, Change From Baseline to End of Treatment Visit
|
-2.4 Units on a scale
Standard Deviation 36.3
|
SECONDARY outcome
Timeframe: Baseline (cycle 1 day 1) and end of treatment visit.Population: Enrolled participants who completed baseline and end of treatment questionnaires.
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.
Outcome measures
| Measure |
Experimental Arm
n=69 Participants
Received study intervention
|
|---|---|
|
EORCT QLQ-C30: Constipation, Change From Baseline to End of Treatment Visit
|
6.3 Units on a scale
Standard Deviation 33.5
|
SECONDARY outcome
Timeframe: Baseline (cycle 1 day 1) and end of treatment visit.Population: Enrolled participants who completed baseline and end of treatment questionnaires.
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.
Outcome measures
| Measure |
Experimental Arm
n=69 Participants
Received study intervention
|
|---|---|
|
EORTC QLQ-C30: Diarrhoea, Change From Baseline to End of Treatment Visit
|
0.0 Units on a scale
Standard Deviation 18.1
|
SECONDARY outcome
Timeframe: Baseline (cycle 1 day 1) and end of treatment visit.Population: Enrolled participants who completed baseline and end of treatment questionnaires.
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.
Outcome measures
| Measure |
Experimental Arm
n=65 Participants
Received study intervention
|
|---|---|
|
EORTC QLQ-C30: Financial Difficulties, Change From Baseline to End of Treatment Visit
|
10.3 Units on a scale
Standard Deviation 22.0
|
SECONDARY outcome
Timeframe: Baseline (cycle 1 day 1) and end of treatment visit.Population: Enrolled participants who completed baseline and end of treatment questionnaires.
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.
Outcome measures
| Measure |
Experimental Arm
n=73 Participants
Received study intervention
|
|---|---|
|
EORTC QLQ-LC13: Coughing, Change From Baseline to End of Treatment Visit
|
-7.8 Units on a scale
Standard Deviation 29.7
|
SECONDARY outcome
Timeframe: Baseline (cycle 1 day 1) and end of treatment visit.Population: Enrolled participants who completed baseline and end of treatment questionnaires.
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.
Outcome measures
| Measure |
Experimental Arm
n=73 Participants
Received study intervention
|
|---|---|
|
EORTC QLQ-LC13: Haemoptysis, Change From Baseline to End of Treatment Visit
|
-0.5 Units on a scale
Standard Deviation 15.2
|
SECONDARY outcome
Timeframe: Baseline (cycle 1 day 1) and end of treatment visit.Population: Enrolled participants who completed baseline and end of treatment questionnaires.
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.
Outcome measures
| Measure |
Experimental Arm
n=68 Participants
Received study intervention
|
|---|---|
|
EORTC QLQ-LC13: Dyspnoea, Change From Baseline to End of Treatment Visit
|
3.1 Units on a scale
Standard Deviation 24.1
|
SECONDARY outcome
Timeframe: Baseline (cycle 1 day 1) and end of treatment visit.Population: Enrolled participants who completed baseline and end of treatment questionnaires.
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.
Outcome measures
| Measure |
Experimental Arm
n=71 Participants
Received study intervention
|
|---|---|
|
EORTC QLQ-LC13: Pain in Arm or Shoulder, Change From Baseline to End of Treatment Visit
|
3.3 Units on a scale
Standard Deviation 33.4
|
SECONDARY outcome
Timeframe: Baseline (cycle 1 day 1) and end of treatment visit.Population: Enrolled participants who completed baseline and end of treatment questionnaires.
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.
Outcome measures
| Measure |
Experimental Arm
n=68 Participants
Received study intervention
|
|---|---|
|
EORTC QLQ-LC13: Pain in Other Parts, Change From Baseline to End of Treatment Visit
|
7.4 Units on a scale
Standard Deviation 39.4
|
SECONDARY outcome
Timeframe: Baseline (cycle 1 day 1) and end of treatment visit.Population: Enrolled participants who completed baseline and end of treatment questionnaires.
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.
Outcome measures
| Measure |
Experimental Arm
n=71 Participants
Received study intervention
|
|---|---|
|
EORTC QLQ-LC13: Sore Mouth, Change From Baseline to End of Treatment Visit
|
2.3 Units on a scale
Standard Deviation 13.0
|
SECONDARY outcome
Timeframe: Baseline (cycle 1 day 1) and end of treatment visit.Population: Enrolled participants who completed baseline and end of treatment questionnaires.
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.
Outcome measures
| Measure |
Experimental Arm
n=71 Participants
Received study intervention
|
|---|---|
|
EORTC QLQ-LC13: Peripheral Neuropathy, Change From Baseline to End of Treatment Visit
|
13.6 Units on a scale
Standard Deviation 27.4
|
SECONDARY outcome
Timeframe: Baseline (cycle 1 day 1) and end of treatment visit.Population: Enrolled participants who completed baseline and end of treatment questionnaires.
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.
Outcome measures
| Measure |
Experimental Arm
n=72 Participants
Received study intervention
|
|---|---|
|
EORTC QLQ-LC13: Alopecia, Change From Baseline to End of Treatment Visit
|
18.1 Units on a scale
Standard Deviation 37.5
|
SECONDARY outcome
Timeframe: Baseline (cycle 1 day 1) and end of treatment visit.Population: Enrolled participants who completed baseline and end of treatment questionnaires.
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.
Outcome measures
| Measure |
Experimental Arm
n=72 Participants
Received study intervention
|
|---|---|
|
EORTC QLQ-LC13: Dysphagia, Change From Baseline to End of Treatment Visit
|
2.8 Units on a scale
Standard Deviation 23.6
|
SECONDARY outcome
Timeframe: Baseline (cycle 1 day 1) and end of treatment visit.Population: Enrolled participants who completed baseline and end of treatment questionnaires.
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.
Outcome measures
| Measure |
Experimental Arm
n=73 Participants
Received study intervention
|
|---|---|
|
EORTC QLQ-LC13: Chest Pain Item Change From Baseline to End of Treatment Visit
|
-1.8 Units on a scale
Standard Deviation 29.3
|
Adverse Events
Experimental Arm
Serious adverse events
| Measure |
Experimental Arm
n=101 participants at risk
Received study intervention
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.9%
8/101 • Number of events 10 • During study treatment, until disease progression (median 6 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
2/101 • Number of events 2 • During study treatment, until disease progression (median 6 months)
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.0%
2/101 • Number of events 3 • During study treatment, until disease progression (median 6 months)
|
|
Cardiac disorders
Atrial flutter
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Cardiac disorders
Cardiac failure
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
2.0%
2/101 • Number of events 2 • During study treatment, until disease progression (median 6 months)
|
|
Eye disorders
Diplopia
|
0.99%
1/101 • Number of events 2 • During study treatment, until disease progression (median 6 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Gastrointestinal disorders
Haematemesis
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
2/101 • Number of events 2 • During study treatment, until disease progression (median 6 months)
|
|
General disorders
Chest pain
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
General disorders
Pyrexia
|
5.0%
5/101 • Number of events 5 • During study treatment, until disease progression (median 6 months)
|
|
Hepatobiliary disorders
Bile duct stone
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Hepatobiliary disorders
Hepatitis
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Infections and infestations
Bronchitis
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Infections and infestations
COVID-19
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Infections and infestations
COVID-19 pneumonia
|
2.0%
2/101 • Number of events 2 • During study treatment, until disease progression (median 6 months)
|
|
Infections and infestations
Herpes zoster reactivation
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Infections and infestations
Pneumonia
|
5.9%
6/101 • Number of events 6 • During study treatment, until disease progression (median 6 months)
|
|
Infections and infestations
Respiratory tract infection
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Infections and infestations
Sepsis
|
4.0%
4/101 • Number of events 4 • During study treatment, until disease progression (median 6 months)
|
|
Infections and infestations
Staphylococcal infection
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Infections and infestations
Urinary tract infection
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Injury, poisoning and procedural complications
Radial head dislocation
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Investigations
Neutrophil count decreased
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Investigations
Transaminases increased
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.0%
3/101 • Number of events 4 • During study treatment, until disease progression (median 6 months)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.99%
1/101 • Number of events 2 • During study treatment, until disease progression (median 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Nervous system disorders
Cerebellar syndrome
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Nervous system disorders
Dizziness
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Nervous system disorders
Immune-mediated neurological disorder
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Nervous system disorders
Multiple sclerosis
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Nervous system disorders
Neurological decompensation
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Nervous system disorders
Seizure
|
2.0%
2/101 • Number of events 3 • During study treatment, until disease progression (median 6 months)
|
|
Nervous system disorders
Spinal cord compression
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Nervous system disorders
Syncope
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Psychiatric disorders
Confusional state
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Renal and urinary disorders
Nephritis
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Renal and urinary disorders
Renal tubular disorder
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.0%
4/101 • Number of events 4 • During study treatment, until disease progression (median 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.0%
3/101 • Number of events 3 • During study treatment, until disease progression (median 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.99%
1/101 • Number of events 3 • During study treatment, until disease progression (median 6 months)
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.99%
1/101 • Number of events 2 • During study treatment, until disease progression (median 6 months)
|
|
Vascular disorders
Peripheral ischaemia
|
0.99%
1/101 • Number of events 1 • During study treatment, until disease progression (median 6 months)
|
|
Vascular disorders
Superior vena cava syndrome
|
2.0%
2/101 • Number of events 2 • During study treatment, until disease progression (median 6 months)
|
Other adverse events
| Measure |
Experimental Arm
n=101 participants at risk
Received study intervention
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
49.5%
50/101 • Number of events 125 • During study treatment, until disease progression (median 6 months)
|
|
General disorders
Asthenia
|
63.4%
64/101 • Number of events 157 • During study treatment, until disease progression (median 6 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.7%
34/101 • Number of events 56 • During study treatment, until disease progression (median 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
30.7%
31/101 • Number of events 40 • During study treatment, until disease progression (median 6 months)
|
|
Gastrointestinal disorders
Constipation
|
26.7%
27/101 • Number of events 35 • During study treatment, until disease progression (median 6 months)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
23.8%
24/101 • Number of events 31 • During study treatment, until disease progression (median 6 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
20.8%
21/101 • Number of events 25 • During study treatment, until disease progression (median 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.8%
23/101 • Number of events 28 • During study treatment, until disease progression (median 6 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
18.8%
19/101 • Number of events 27 • During study treatment, until disease progression (median 6 months)
|
|
Gastrointestinal disorders
Nausea
|
17.8%
18/101 • Number of events 22 • During study treatment, until disease progression (median 6 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.8%
18/101 • Number of events 19 • During study treatment, until disease progression (median 6 months)
|
|
General disorders
Pyrexia
|
14.9%
15/101 • Number of events 17 • During study treatment, until disease progression (median 6 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.8%
16/101 • Number of events 19 • During study treatment, until disease progression (median 6 months)
|
|
Endocrine disorders
Hypothyroidism
|
14.9%
15/101 • Number of events 19 • During study treatment, until disease progression (median 6 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.9%
14/101 • Number of events 23 • During study treatment, until disease progression (median 6 months)
|
|
Gastrointestinal disorders
Vomiting
|
11.9%
12/101 • Number of events 14 • During study treatment, until disease progression (median 6 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.9%
12/101 • Number of events 13 • During study treatment, until disease progression (median 6 months)
|
|
Investigations
Platelet count decreased
|
10.9%
11/101 • Number of events 15 • During study treatment, until disease progression (median 6 months)
|
|
General disorders
Mucosal inflammation
|
9.9%
10/101 • Number of events 12 • During study treatment, until disease progression (median 6 months)
|
|
Infections and infestations
Respiratory tract infection
|
9.9%
10/101 • Number of events 12 • During study treatment, until disease progression (median 6 months)
|
|
Infections and infestations
Urinary tract infection
|
8.9%
9/101 • Number of events 11 • During study treatment, until disease progression (median 6 months)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
9.9%
10/101 • Number of events 12 • During study treatment, until disease progression (median 6 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.9%
9/101 • Number of events 16 • During study treatment, until disease progression (median 6 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.9%
9/101 • Number of events 13 • During study treatment, until disease progression (median 6 months)
|
|
General disorders
Oedema peripheral
|
7.9%
8/101 • Number of events 13 • During study treatment, until disease progression (median 6 months)
|
|
Investigations
Neutrophil count decreased
|
7.9%
8/101 • Number of events 15 • During study treatment, until disease progression (median 6 months)
|
|
Nervous system disorders
Headache
|
7.9%
8/101 • Number of events 8 • During study treatment, until disease progression (median 6 months)
|
|
Psychiatric disorders
Insomnia
|
7.9%
8/101 • Number of events 8 • During study treatment, until disease progression (median 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.9%
7/101 • Number of events 7 • During study treatment, until disease progression (median 6 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.9%
8/101 • Number of events 11 • During study treatment, until disease progression (median 6 months)
|
|
Endocrine disorders
Hyperthyroidism
|
6.9%
7/101 • Number of events 8 • During study treatment, until disease progression (median 6 months)
|
|
Investigations
Alanine aminotransferase increased
|
6.9%
7/101 • Number of events 10 • During study treatment, until disease progression (median 6 months)
|
|
Investigations
Amylase increased
|
6.9%
7/101 • Number of events 16 • During study treatment, until disease progression (median 6 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.9%
7/101 • Number of events 7 • During study treatment, until disease progression (median 6 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
5.9%
6/101 • Number of events 6 • During study treatment, until disease progression (median 6 months)
|
|
General disorders
Fatigue
|
5.9%
6/101 • Number of events 10 • During study treatment, until disease progression (median 6 months)
|
|
General disorders
Illness
|
5.9%
6/101 • Number of events 8 • During study treatment, until disease progression (median 6 months)
|
|
Infections and infestations
COVID-19
|
5.0%
5/101 • Number of events 5 • During study treatment, until disease progression (median 6 months)
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
6/101 • Number of events 9 • During study treatment, until disease progression (median 6 months)
|
|
Nervous system disorders
Dizziness
|
5.0%
5/101 • Number of events 6 • During study treatment, until disease progression (median 6 months)
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.0%
5/101 • Number of events 11 • During study treatment, until disease progression (median 6 months)
|
|
Investigations
Lymphocyte count decreased
|
5.0%
5/101 • Number of events 13 • During study treatment, until disease progression (median 6 months)
|
|
Nervous system disorders
Dysgeusia
|
5.0%
5/101 • Number of events 6 • During study treatment, until disease progression (median 6 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place