Trial Outcomes & Findings for OSE2101 Versus Chemotherapy in HLA-A2 Positive Patients With Advanced NSCLC After Immune Checkpoint Inhibitor Failure (NCT NCT02654587)
NCT ID: NCT02654587
Last Updated: 2024-02-02
Results Overview
OS defined as the time from randomisation to death from any cause in patients with ICI secondary resistance
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
219 participants
Primary outcome timeframe
Approx. 24 months
Results posted on
2024-02-02
Participant Flow
From Feb 2016 to Apr 2020, patients with advanced NSCLC were recruited in clinics or hospitals specialized in oncology in Europe, US and Israel to prescreen potential patients for HLA-A2 typing (by central lab). Only HLA-A2 positive patients who fulfilled all eligibility criteria were randomized. A total of 219 patients with ICI resistance were randomized, including 118 patients with ICI secondary resistance (disease progression after ICI \>= 12 weeks - primary population for efficacy analysis)
Only patient with HLA-A2 positive phenotype were eligible
Participant milestones
| Measure |
OSE2101
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and therafter every 12 weeks
|
Docetaxel or Pemetrexed
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
|
|---|---|---|
|
Overall Study
STARTED
|
139
|
80
|
|
Overall Study
COMPLETED
|
116
|
65
|
|
Overall Study
NOT COMPLETED
|
23
|
15
|
Reasons for withdrawal
| Measure |
OSE2101
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and therafter every 12 weeks
|
Docetaxel or Pemetrexed
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
|
|---|---|---|
|
Overall Study
patient alive at end of study
|
22
|
8
|
|
Overall Study
Withdrawal by Subject
|
1
|
7
|
Baseline Characteristics
Missing data in 11 patients (n=9 in OSE2101 arm, n=2 in docetaxel or pemetrexed arm)
Baseline characteristics by cohort
| Measure |
OSE2101
n=139 Participants
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks
|
Docetaxel or Pemetrexed
n=80 Participants
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
|
Total
n=219 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
All patients with ICI primary and secondary resistance · white
|
124 Participants
n=130 Participants • Missing data in 11 patients (n=9 in OSE2101 arm, n=2 in docetaxel or pemetrexed arm)
|
76 Participants
n=78 Participants • Missing data in 11 patients (n=9 in OSE2101 arm, n=2 in docetaxel or pemetrexed arm)
|
200 Participants
n=208 Participants • Missing data in 11 patients (n=9 in OSE2101 arm, n=2 in docetaxel or pemetrexed arm)
|
|
Age, Categorical
All randomized patients with ICI primary and secondary resistance · <=18 years
|
0 Participants
n=139 Participants • Primary efficacy analysis was carried out in the subgroup of patients with ICI secondary resistance defined as as disease progression after ICI second line \> or equal to 12 weeks identified from the stratification factor (previous line of ICI). Safety analysis was done in all patients.
|
0 Participants
n=80 Participants • Primary efficacy analysis was carried out in the subgroup of patients with ICI secondary resistance defined as as disease progression after ICI second line \> or equal to 12 weeks identified from the stratification factor (previous line of ICI). Safety analysis was done in all patients.
|
0 Participants
n=219 Participants • Primary efficacy analysis was carried out in the subgroup of patients with ICI secondary resistance defined as as disease progression after ICI second line \> or equal to 12 weeks identified from the stratification factor (previous line of ICI). Safety analysis was done in all patients.
|
|
Age, Categorical
All randomized patients with ICI primary and secondary resistance · Between 18 and 65 years
|
69 Participants
n=139 Participants • Primary efficacy analysis was carried out in the subgroup of patients with ICI secondary resistance defined as as disease progression after ICI second line \> or equal to 12 weeks identified from the stratification factor (previous line of ICI). Safety analysis was done in all patients.
|
45 Participants
n=80 Participants • Primary efficacy analysis was carried out in the subgroup of patients with ICI secondary resistance defined as as disease progression after ICI second line \> or equal to 12 weeks identified from the stratification factor (previous line of ICI). Safety analysis was done in all patients.
|
114 Participants
n=219 Participants • Primary efficacy analysis was carried out in the subgroup of patients with ICI secondary resistance defined as as disease progression after ICI second line \> or equal to 12 weeks identified from the stratification factor (previous line of ICI). Safety analysis was done in all patients.
|
|
Age, Categorical
All randomized patients with ICI primary and secondary resistance · >=65 years
|
70 Participants
n=139 Participants • Primary efficacy analysis was carried out in the subgroup of patients with ICI secondary resistance defined as as disease progression after ICI second line \> or equal to 12 weeks identified from the stratification factor (previous line of ICI). Safety analysis was done in all patients.
|
35 Participants
n=80 Participants • Primary efficacy analysis was carried out in the subgroup of patients with ICI secondary resistance defined as as disease progression after ICI second line \> or equal to 12 weeks identified from the stratification factor (previous line of ICI). Safety analysis was done in all patients.
|
105 Participants
n=219 Participants • Primary efficacy analysis was carried out in the subgroup of patients with ICI secondary resistance defined as as disease progression after ICI second line \> or equal to 12 weeks identified from the stratification factor (previous line of ICI). Safety analysis was done in all patients.
|
|
Age, Continuous
All randomized patients with ICI primary and secondary resistance
|
65.3 years
n=139 Participants • Final analysis was carried out in the subgroup of patients with ICI secondary resistance defined as as disease progression after ICI second line \> or equal to 12 weeks identified from the stratification factor (previous line of ICI)
|
63.6 years
n=80 Participants • Final analysis was carried out in the subgroup of patients with ICI secondary resistance defined as as disease progression after ICI second line \> or equal to 12 weeks identified from the stratification factor (previous line of ICI)
|
64.7 years
n=219 Participants • Final analysis was carried out in the subgroup of patients with ICI secondary resistance defined as as disease progression after ICI second line \> or equal to 12 weeks identified from the stratification factor (previous line of ICI)
|
|
Sex: Female, Male
All patients with ICI primary and secondary resistance · Female
|
40 Participants
n=139 Participants • Primary efficacy analysis was carried out in the subgroup of patients with ICI secondary resistance defined as as disease progression after ICI second line \> or equal to 12 weeks identified from the stratification factor (previous line of ICI)/ Safety analysis was done in all patients
|
24 Participants
n=80 Participants • Primary efficacy analysis was carried out in the subgroup of patients with ICI secondary resistance defined as as disease progression after ICI second line \> or equal to 12 weeks identified from the stratification factor (previous line of ICI)/ Safety analysis was done in all patients
|
64 Participants
n=219 Participants • Primary efficacy analysis was carried out in the subgroup of patients with ICI secondary resistance defined as as disease progression after ICI second line \> or equal to 12 weeks identified from the stratification factor (previous line of ICI)/ Safety analysis was done in all patients
|
|
Sex: Female, Male
All patients with ICI primary and secondary resistance · Male
|
99 Participants
n=139 Participants • Primary efficacy analysis was carried out in the subgroup of patients with ICI secondary resistance defined as as disease progression after ICI second line \> or equal to 12 weeks identified from the stratification factor (previous line of ICI)/ Safety analysis was done in all patients
|
56 Participants
n=80 Participants • Primary efficacy analysis was carried out in the subgroup of patients with ICI secondary resistance defined as as disease progression after ICI second line \> or equal to 12 weeks identified from the stratification factor (previous line of ICI)/ Safety analysis was done in all patients
|
155 Participants
n=219 Participants • Primary efficacy analysis was carried out in the subgroup of patients with ICI secondary resistance defined as as disease progression after ICI second line \> or equal to 12 weeks identified from the stratification factor (previous line of ICI)/ Safety analysis was done in all patients
|
|
Race/Ethnicity, Customized
All patients with ICI primary and secondary resistance · Black or African American
|
4 Participants
n=130 Participants • Missing data in 11 patients (n=9 in OSE2101 arm, n=2 in docetaxel or pemetrexed arm)
|
2 Participants
n=78 Participants • Missing data in 11 patients (n=9 in OSE2101 arm, n=2 in docetaxel or pemetrexed arm)
|
6 Participants
n=208 Participants • Missing data in 11 patients (n=9 in OSE2101 arm, n=2 in docetaxel or pemetrexed arm)
|
|
Race/Ethnicity, Customized
All patients with ICI primary and secondary resistance · Asian
|
2 Participants
n=130 Participants • Missing data in 11 patients (n=9 in OSE2101 arm, n=2 in docetaxel or pemetrexed arm)
|
0 Participants
n=78 Participants • Missing data in 11 patients (n=9 in OSE2101 arm, n=2 in docetaxel or pemetrexed arm)
|
2 Participants
n=208 Participants • Missing data in 11 patients (n=9 in OSE2101 arm, n=2 in docetaxel or pemetrexed arm)
|
|
Region of Enrollment
United States
|
14 participants
n=139 Participants
|
5 participants
n=80 Participants
|
7 participants
n=219 Participants
|
|
Region of Enrollment
Czechia
|
0 participants
n=139 Participants
|
1 participants
n=80 Participants
|
1 participants
n=219 Participants
|
|
Region of Enrollment
Poland
|
1 participants
n=139 Participants
|
3 participants
n=80 Participants
|
2 participants
n=219 Participants
|
|
Region of Enrollment
Italy
|
30 participants
n=139 Participants
|
18 participants
n=80 Participants
|
31 participants
n=219 Participants
|
|
Region of Enrollment
Israel
|
8 participants
n=139 Participants
|
3 participants
n=80 Participants
|
4 participants
n=219 Participants
|
|
Region of Enrollment
France
|
51 participants
n=139 Participants
|
31 participants
n=80 Participants
|
46 participants
n=219 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=139 Participants
|
3 participants
n=80 Participants
|
1 participants
n=219 Participants
|
|
Region of Enrollment
Spain
|
33 participants
n=139 Participants
|
15 participants
n=80 Participants
|
26 participants
n=219 Participants
|
|
Region of Enrollment
Hungary
|
0 participants
n=139 Participants
|
1 participants
n=80 Participants
|
1 participants
n=219 Participants
|
PRIMARY outcome
Timeframe: Approx. 24 monthsPopulation: OS analysis in patients with ICI secondary resistance defined as disease progression after ICI second line \> or equal to 12 weeks (n=118) OS analysis in the ITT population with ICI resistance (primary and secondary resistance) is described in statistical analysis 2 (n=219)
OS defined as the time from randomisation to death from any cause in patients with ICI secondary resistance
Outcome measures
| Measure |
OSE2101
n=80 Participants
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks
|
Docetaxel or Pemetrexed
n=38 Participants
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
|
|---|---|---|
|
Overall Survival (OS)
|
11.1 Months
Interval 8.6 to 13.5
|
7.5 Months
Interval 4.7 to 10.3
|
SECONDARY outcome
Timeframe: approximately 24 monthsPopulation: Patients with ICI secondary resistance defined as disease progression after ICI second line \> or equal to 12 weeks (n=118)
Post-progression survival was defined as the time from the earliest date of progression according to RECIST 1.1 until death in patients with ICI secondary resistance
Outcome measures
| Measure |
OSE2101
n=80 Participants
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks
|
Docetaxel or Pemetrexed
n=38 Participants
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
|
|---|---|---|
|
Post-Progression Survival
|
7.7 months
Interval 5.6 to 9.7
|
4.6 months
Interval 3.1 to 5.8
|
SECONDARY outcome
Timeframe: Approx. 24 monthsPopulation: Patients with ICI secondary resistance
Time to Worsening ECOG PS was defined as the time from randomization to the earliest date when ECOG PS was \>1 in patients with ICI secondary resistance. Time to worsening ECPG PS was summarized by treatment arm using the Kaplan-Meier method. The median event time for each treatment arm and the corresponding 2-sided 95% confidence interval were provided. By protocol, ECOG PS was not collected when a patient permanenetly discontinued the study treatment. Patients without ECOG PS worsening were censored at the last time when an ECOG value was recorded.
Outcome measures
| Measure |
OSE2101
n=80 Participants
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks
|
Docetaxel or Pemetrexed
n=38 Participants
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
|
|---|---|---|
|
Time to Worsening ECOG PS
|
9.0 months
Interval 6.3 to 9.9
|
3.3 months
Interval 2.3 to 6.7
|
SECONDARY outcome
Timeframe: Approx. 24 monthsPopulation: Patients with ICI secondary resistance
Mean change from baseline to treatment discontinuation in Quality of Life (QoL) score of the following functional subscales analyzed separately: global health status, physical, role, cognitive, emotional and social functioning. Each score range from 0 to 100 after normalisation. Highest scores correspond to a better quality of life. The mean score change was assessed using a mixed-effects model for repeated measures analysis with the patient as the random effect, treatment, visit and treatment-by-visit interaction as explanatory variables and baseline score as covariates. If the mean score change is negative, it means a deterioration of QoL. If the mean score change is positive or 0, it means an improvement or stability of QoL
Outcome measures
| Measure |
OSE2101
n=70 Participants
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks
|
Docetaxel or Pemetrexed
n=25 Participants
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
|
|---|---|---|
|
Mean Changes in Functional Subscales of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Physical functioning
|
-2.74 score on a scale
Interval -6.21 to 0.73
|
-8.75 score on a scale
Interval -14.17 to -3.33
|
|
Mean Changes in Functional Subscales of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Social funtioning
|
-3.82 score on a scale
Interval -8.3 to 0.66
|
-10.43 score on a scale
Interval -17.23 to -3.64
|
|
Mean Changes in Functional Subscales of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Global Health Status
|
0.77 score on a scale
Interval -2.92 to 4.47
|
-6.19 score on a scale
Interval -11.83 to -0.55
|
|
Mean Changes in Functional Subscales of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Role functioning
|
-5.09 score on a scale
Interval -10.6 to 0.43
|
-16.78 score on a scale
Interval -25.29 to -8.28
|
|
Mean Changes in Functional Subscales of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Emotional functioning
|
0.50 score on a scale
Interval -3.29 to 4.28
|
-2.75 score on a scale
Interval -8.63 to 3.12
|
|
Mean Changes in Functional Subscales of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Cognitive functioning
|
-3.20 score on a scale
Interval -7.18 to 0.78
|
-7.64 score on a scale
Interval -13.86 to -1.43
|
SECONDARY outcome
Timeframe: Approx. 24 monthsPopulation: QLQ-C30 Symptoms score changes from baseline in patients with ICI secondary resistance
Mean change from baseline to treatment discontinuation in Quality of Life (QoL) score of the following symptoms subscales analyzed separately: Fatigue, Constipation, Dyspnea, Nausea and Vomiting, Pain, Insomnia, Appetite loss, Diarrhea, Financial Difficulties. Each score range from 0 to 100 after normalisation. Lowest scores correspond to a better QoL. The mean score change was assessed using a mixed-effects model for repeated measures analysis with the patient as the random effect, treatment, visit and treatment-by-visit interaction as explanatory variables and baseline score as covariates. If the mean score change is negative, it means a deterioration of QoL. If the mean score change is positive or 0, it means an improvement or stability of QoL.
Outcome measures
| Measure |
OSE2101
n=70 Participants
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks
|
Docetaxel or Pemetrexed
n=25 Participants
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
|
|---|---|---|
|
Mean Changes in Symptoms Subscales of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Fatigue
|
4.47 score on a scale
Interval 0.21 to 8.72
|
11.95 score on a scale
Interval 5.44 to 18.46
|
|
Mean Changes in Symptoms Subscales of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Dyspnea
|
3.99 score on a scale
Interval -1.26 to 9.24
|
2.77 score on a scale
Interval -5.24 to 10.77
|
|
Mean Changes in Symptoms Subscales of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Pain
|
4.23 score on a scale
Interval -0.73 to 9.19
|
0.71 score on a scale
Interval -7.01 to 8.43
|
|
Mean Changes in Symptoms Subscales of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Insomnia
|
0.42 score on a scale
Interval -4.25 to 5.08
|
-0.29 score on a scale
Interval -7.24 to 6.65
|
|
Mean Changes in Symptoms Subscales of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Constipation
|
-5.57 score on a scale
Interval -9.5 to -1.64
|
7.84 score on a scale
Interval 1.97 to 13.71
|
|
Mean Changes in Symptoms Subscales of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Nausea and Vomiting
|
-1.49 score on a scale
Interval -3.83 to 0.84
|
1.21 score on a scale
Interval -2.37 to 4.8
|
|
Mean Changes in Symptoms Subscales of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Appetite loss
|
0.08 score on a scale
Interval -4.79 to 4.94
|
-2.33 score on a scale
Interval -9.66 to 4.99
|
|
Mean Changes in Symptoms Subscales of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Diarrhea
|
-4.12 score on a scale
Interval -7.85 to -0.38
|
-3.85 score on a scale
Interval -9.33 to 2.16
|
|
Mean Changes in Symptoms Subscales of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Financial difficulties
|
2.22 score on a scale
Interval -2.15 to 6.59
|
5.82 score on a scale
Interval -0.82 to 12.45
|
SECONDARY outcome
Timeframe: Approx. 24 monthsPopulation: QLQ-LC 13 symptoms score changes from baseline in patients with ICI secondary resistance
Mean change from baseline to treatment discontinuation in Quality of Life (QoL) score of the following symptoms subscales analyzed separately: Alopecia, Peripheral Neuropathy, Sore mouth, Dysphagia, Dyspnea, Pain in arm or shoulder, Pain in chest, Pain in other parts, Hemoptysis, Coughing. Each score range from 0 to 100 after normalisation. Lowest scores correspond to a better QoL. The mean score change was assessed using a mixed-effects model for repeated measures analysis with the patient as the random effect, treatment, visit and treatment-by-visit interaction as explanatory variables and baseline score as covariates. If the mean score change is negative, it means a deterioration of QoL. If the mean score change is positive or 0, it means an improvement or stability of QoL.
Outcome measures
| Measure |
OSE2101
n=70 Participants
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks
|
Docetaxel or Pemetrexed
n=25 Participants
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
|
|---|---|---|
|
Mean Changes in Symptoms Subscales of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Lung Cancer (QLQ-LC13) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Alopecia
|
0.44 units on a scale
Interval -4.74 to 5.63
|
25.83 units on a scale
Interval 17.52 to 34.14
|
|
Mean Changes in Symptoms Subscales of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Lung Cancer (QLQ-LC13) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Peripheral neuropathy
|
2.65 units on a scale
Interval -2.33 to 7.63
|
13.23 units on a scale
Interval 5.37 to 21.08
|
|
Mean Changes in Symptoms Subscales of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Lung Cancer (QLQ-LC13) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Dyspnea
|
4.99 units on a scale
Interval 0.87 to 9.11
|
5.19 units on a scale
Interval -1.57 to 11.95
|
|
Mean Changes in Symptoms Subscales of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Lung Cancer (QLQ-LC13) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Pain in arm or shoulder
|
5.00 units on a scale
Interval 0.6 to 9.39
|
1.16 units on a scale
Interval -5.7 to 8.02
|
|
Mean Changes in Symptoms Subscales of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Lung Cancer (QLQ-LC13) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Pain in chest
|
1.61 units on a scale
Interval -2.38 to 5.6
|
-1.37 units on a scale
Interval -7.61 to 4.86
|
|
Mean Changes in Symptoms Subscales of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Lung Cancer (QLQ-LC13) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Hemoptysis
|
0.05 units on a scale
Interval -1.61 to 1.71
|
-1.84 units on a scale
Interval -4.44 to 0.75
|
|
Mean Changes in Symptoms Subscales of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Lung Cancer (QLQ-LC13) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Coughing
|
-3.62 units on a scale
Interval -8.85 to 1.61
|
-6.67 units on a scale
Interval -14.92 to 1.58
|
|
Mean Changes in Symptoms Subscales of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Lung Cancer (QLQ-LC13) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Sore mouth
|
0.82 units on a scale
Interval -2.27 to 3.91
|
8.52 units on a scale
Interval 3.69 to 13.35
|
|
Mean Changes in Symptoms Subscales of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Lung Cancer (QLQ-LC13) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Dysphagia
|
0.44 units on a scale
Interval -2.49 to 3.37
|
7.41 units on a scale
Interval 2.85 to 11.98
|
|
Mean Changes in Symptoms Subscales of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Lung Cancer (QLQ-LC13) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Pain in other parts
|
8.17 units on a scale
Interval 1.98 to 14.37
|
6.56 units on a scale
Interval -3.04 to 13.17
|
SECONDARY outcome
Timeframe: Approx. 6 monthsPopulation: 116 out of 118 patients had measurable lesions per RECIST 1.1 at baseline (n=78/80 in OSE2101 arm, 38/38 in docetaxel or pemetrexed arm). One patient had no post-baseline RECIST 1.1 assessement (n=1 in OSE2101 arm).
DCR at 6 months defined as the number of patients with Complete Response (CR), Partial Response (PR) or Stable Disease (SD) assessed by investigator per "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions based on CT scan in patients with ICI secondary resistance. Complete Response (CR) defined as disappearance of all target lesions; Partial Response (PR) as \>=30% decrease in the sum of the longest diameter of target lesions; Stable disease (SD) defined as neither sufficient shrinkage (compared to baseline) to qualify for CR or PR nor sufficient increase (taking as reference the smallest sum of diameters at baseline or while on study, whichever is smallest) to qualify for progressive disease (PD) (e.g. decrease of the sum of the longest diameters of target lesions \<30% or increase up to 20%)
Outcome measures
| Measure |
OSE2101
n=78 Participants
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks
|
Docetaxel or Pemetrexed
n=38 Participants
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
|
|---|---|---|
|
Disease Control Rate (DCR) at 6 Months
|
24.7 percentage of participants
Interval 15.6 to 35.8
|
23.7 percentage of participants
Interval 11.4 to 40.2
|
SECONDARY outcome
Timeframe: Approx. 24 monthsPFS was defined as the time from randomization to the earliest date of progression assessed by investigator per "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions based on CT scan in patients with ICI secondary resistance. Progressive disease (PD) defined as increase of target lesions \>=20% taking as reference the smallest sum of diameters at baseline or while on study, whichever is smallest)
Outcome measures
| Measure |
OSE2101
n=80 Participants
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks
|
Docetaxel or Pemetrexed
n=38 Participants
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
|
|---|---|---|
|
Progression Free Survival (PFS) in Patients With ICI Secondary Resistance
|
2.69 Months
Interval 1.61 to 2.79
|
2.99 Months
Interval 2.56 to 4.47
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Approx. 24 monthsPopulation: 116 out of 118 patients had measurable lesions per RECIST 1.1 at baseline (n=78/80 in OSE2101 arm, 38/38 in docetaxel or pemetrexed arm). One patient had no post-baseline RECIST 1.1 assessement (n=1 in OSE2101 arm)
Objective Response rate (OOR) was defined as number of patients with Complete Response (CR) + Partial Response (PR) assessed by investigator per "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions based on CT scan in patients with ICI secondary resistance. Complete Response (CR) defined as disappearance of all target lesions; Partial Response (PR) as \>=30% decrease in the sum of the longest diameter of target lesions. Investigator-assessed ORR was an exploratory endpoint as not relevant as primary, nor secondary endpoints to evaluate a cancer vaccine.
Outcome measures
| Measure |
OSE2101
n=78 Participants
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks
|
Docetaxel or Pemetrexed
n=38 Participants
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
|
|---|---|---|
|
Objective Response Rate (ORR) in ICI Secondary Resistance
|
7.7 percentage of participants
Interval 2.9 to 16.0
|
18.4 percentage of participants
Interval 7.7 to 34.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Approx. 6 monthsPopulation: 22 out of 118 patients had an ORR and was analyzed for duration of response (n=7/80 in OSE2101 arm, 15/38 in docetaxel or pemetrexed arm).
Duration of Objective Response (OOR) was defined as number of patients with Complete Response (CR) or Partial Response (PR) at 6 months assessed by investigator per "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions based on CT scan in patients with ICI secondary resistance. Complete Response (CR) defined as disappearance of all target lesions; Partial Response (PR) as \>=30% decrease in the sum of the longest diameter of target lesions
Outcome measures
| Measure |
OSE2101
n=7 Participants
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks
|
Docetaxel or Pemetrexed
n=15 Participants
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
|
|---|---|---|
|
Percentage of Patients With Objective Response at 6 Months in ICI Secondary Resistance
|
33.3 percentage of with objective response
Interval 4.6 to 67.6
|
26.8 percentage of with objective response
Interval 1.3 to 67.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Approx. 24 monthsTime to next lung cancer therapy was defined as the time from randomisation to the date of initiation of the first lung cancer therapy during the survival follow-up form
Outcome measures
| Measure |
OSE2101
n=80 Participants
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks
|
Docetaxel or Pemetrexed
n=38 Participants
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
|
|---|---|---|
|
Time to Next Lung Cancer Therapy in ICI Secondary Resistance
|
5.4 months
Interval 4.8 to 7.7
|
9.4 months
Interval 6.3 to 14.1
|
POST_HOC outcome
Timeframe: Approx. 24 monthsSurvival was assessed from date of randomisation to death in the pre COVID-19 pandemic (patients randomised before february 2019 and followed up to 12 months) and during COVID-19 pandemic (patients randomised after february 2019 and followed up to january 2021)
Outcome measures
| Measure |
OSE2101
n=103 Participants
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks
|
Docetaxel or Pemetrexed
n=116 Participants
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
|
|---|---|---|
|
Overall Survival Before and During the COVID-19 Period
|
9.4 months
Interval 8.0 to 12.2
|
8.1 months
Interval 6.5 to 9.1
|
Adverse Events
OSE2101
Serious events: 47 serious events
Other events: 125 other events
Deaths: 116 deaths
Docetaxel or Pemetrexed
Serious events: 33 serious events
Other events: 67 other events
Deaths: 65 deaths
Serious adverse events
| Measure |
OSE2101
n=139 participants at risk
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks
|
Docetaxel or Pemetrexed
n=80 participants at risk
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
|
|---|---|---|
|
Gastrointestinal disorders
enterocolitis
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
1.2%
1/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Gastrointestinal disorders
pancreatitis acute
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
General disorders
gait disturbance
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
1.2%
1/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
General disorders
non cardiac chest pain
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Infections and infestations
erysipela
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
1.2%
1/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
1.2%
1/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Injury, poisoning and procedural complications
femur fracture
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
3.8%
3/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
1.2%
1/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Cardiac disorders
Atrial fibrillation
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Cardiac disorders
Atrial flutter
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
1.2%
1/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Endocrine disorders
Adrenal insufficiency
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Gastrointestinal disorders
Diarrhea
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
2.5%
2/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
2.5%
2/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.4%
2/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
1.2%
1/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
2.5%
2/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
General disorders
General physical health deterioration
|
2.9%
4/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
6.2%
5/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
General disorders
Influenza like illness
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
General disorders
Pyrexia
|
1.4%
2/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
1.2%
1/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Immune system disorders
Cytokine release syndrome
|
4.3%
6/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Immune system disorders
Drug hypersensitivity
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Immune system disorders
Giant cell arteritis
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
1.2%
1/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Infections and infestations
COVID-19 pneumoniae
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Infections and infestations
Endocarditis
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
1.2%
1/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
1.2%
1/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Infections and infestations
Pneumonia bacterial
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Infections and infestations
Respiratory tract infection
|
1.4%
2/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
2.5%
2/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Infections and infestations
Sepsis
|
1.4%
2/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
1.2%
1/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
1.2%
1/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
2/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
1.2%
1/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Injury, poisoning and procedural complications
Spinal stenosis
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
1.2%
1/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
2.2%
3/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
3.8%
3/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Nervous system disorders
Balance disorder
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain oedema
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebrovascular accident
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seizure
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
2.5%
2/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Renal and urinary disorders
Renal haematoma
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
1.2%
1/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
1.2%
1/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.2%
3/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
2.5%
2/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
1.2%
1/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
2.5%
2/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Vascular disorders
Hypotension
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Blood and lymphatic system disorders
Anemiae
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
1.2%
1/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
1.2%
1/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Cardiac disorders
acute myocardial infarction
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Gastrointestinal disorders
dysphagia
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
1.2%
1/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
cancer pain
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
metastases to central nervous system
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
paraneoplastic syndrome
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
1.2%
1/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Nervous system disorders
aphasia
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Renal and urinary disorders
urinary tract obstruction
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
1.2%
1/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory distress
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
1.2%
1/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
Other adverse events
| Measure |
OSE2101
n=139 participants at risk
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks
|
Docetaxel or Pemetrexed
n=80 participants at risk
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
6.5%
9/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
16.2%
13/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
16.2%
13/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
5.0%
4/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Cardiac disorders
Tachycardia
|
2.2%
3/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
5.0%
4/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Gastrointestinal disorders
Nausea
|
14.4%
20/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
17.5%
14/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Gastrointestinal disorders
Diarrhea
|
8.6%
12/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
26.2%
21/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Gastrointestinal disorders
Vomiting
|
10.1%
14/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
12.5%
10/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Gastrointestinal disorders
Constipation
|
6.5%
9/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
13.8%
11/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
7/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
1.2%
1/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Gastrointestinal disorders
Stomatitis
|
1.4%
2/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
5.0%
4/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
General disorders
Asthenia
|
23.0%
32/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
40.0%
32/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
General disorders
Pyrexia
|
17.3%
24/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
11.2%
9/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
General disorders
Fatique
|
9.4%
13/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
15.0%
12/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
General disorders
Injection site induration
|
11.5%
16/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
General disorders
Chest pain
|
9.4%
13/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
2.5%
2/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
General disorders
Injection site reaction
|
9.4%
13/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
General disorders
Oedema peripheral
|
5.0%
7/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
8.8%
7/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
General disorders
Chills
|
6.5%
9/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
General disorders
Pain
|
5.0%
7/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
6.2%
5/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
General disorders
Injection site pain
|
7.2%
10/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
0.00%
0/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
General disorders
Oedema
|
1.4%
2/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
5.0%
4/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Infections and infestations
Conjunctivitis
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
6.2%
5/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Investigations
Weight decreased
|
4.3%
6/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
10.0%
8/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.1%
28/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
17.5%
14/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.6%
5/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
6.2%
5/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
5.0%
4/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Metabolism and nutrition disorders
Hypokaliaemia
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
5.0%
4/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.4%
20/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
7.5%
6/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.4%
13/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
10.0%
8/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
7/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
5.0%
4/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
4/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
5.0%
4/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Nervous system disorders
Headache
|
5.0%
7/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
2.5%
2/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
8.8%
7/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.4%
20/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
17.5%
14/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.4%
13/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
10.0%
8/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.6%
5/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
5.0%
4/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.72%
1/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
26.2%
21/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Skin and subcutaneous tissue disorders
Nail toxicity
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
5.0%
4/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Vascular disorders
Hypotension
|
2.2%
3/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
5.0%
4/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
|
Eye disorders
lacrimation increased
|
0.00%
0/139 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
5.0%
4/80 • Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
|
Additional Information
Chief Medical Officer Immuno-Oncology
OSE Immunotherapeutics
Phone: +33 2 28 29 10 10
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place