Trial Outcomes & Findings for Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer (NCT NCT03088813)

Last Updated: 2025-02-19

Results Overview

An adverse event (AE) was any untoward medical occurrence in a participant following or during exposure to a study treatment, whether or not causally related to the study treatment. An undesirable medical condition could be symptoms, signs or abnormal results of an investigation. An SAE was any AE that: resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; resulted in congenital anomaly or birth defect; or was medically important. A TEAE was any AE that occurred or worsened on or after the day of first dose of study treatment and within 30 days after discontinuation of study treatment.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

491 participants

Primary outcome timeframe

The TEAEs were reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration, approximately 680 days

Results posted on

2025-02-19

Participant Flow

This Phase III, 2-part (Part 1: \[open-label, single-arm dose evaluation period\] and Part 2 \[randomized, open-label period\]) study was conducted in participants with small cell lung cancer (SCLC) who progressed on or after platinum-based first-line therapy at 11 sites for Part 1 and 116 sites for Part 2 in the USA, Europe, Asia, Australia, Turkey and Brazil. First participant was enrolled on 25 April 2018 and primary analysis data cut-off (DCO) date was 08 February 2022 for Part 2.

Each part consisted of screening stage (up to 28 days), treatment/active follow-up stage, and a long-term monthly follow-up stage. A total of 30 participants in Part 1 received study treatment and 461 participants in Part 2 were randomized to receive study treatment in this study.

Participant milestones

Participant milestones
Measure	Part 1: Irinotecan Liposome Injection 85 Milligrams/Meter Square (mg/m^2) Participants received irinotecan liposome injection 85 mg/m\^2 intravenously (i.v.) over 90 minutes every 2 weeks in a 6-week cycle until disease progression (PD), death, unacceptable study treatment-related toxicity or withdrawal of consent.	Part 1: Irinotecan Liposome Injection 70 mg/m^2 Participants received irinotecan liposome injection 70 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.	Part 2: Irinotecan Liposome Injection 70 mg/m^2 Eligible participants received irinotecan liposome injection 70 mg/m\^2 i.v. over 90 minutes, every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.	Part 2: Topotecan 1.5 mg/m^2 Eligible participants received topotecan 1.5 mg/m\^2 i.v. over 30 minutes daily for 5 consecutive days, every 3 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.
Part 1: Dose Evaluation (Up to Week 172) STARTED	5	25	0	0
Part 1: Dose Evaluation (Up to Week 172) COMPLETED	5	24	0	0
Part 1: Dose Evaluation (Up to Week 172) NOT COMPLETED	0	1	0	0
Part 2: Randomized Study (Upto Week 197) STARTED	0	0	229	232
Part 2: Randomized Study (Upto Week 197) COMPLETED	0	0	202	211
Part 2: Randomized Study (Upto Week 197) NOT COMPLETED	0	0	27	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: Irinotecan Liposome Injection 70 mg/m^2 Participants received irinotecan liposome injection 70 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.	Part 2: Irinotecan Liposome Injection 70 mg/m^2 Eligible participants received irinotecan liposome injection 70 mg/m\^2 i.v. over 90 minutes, every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.	Part 2: Topotecan 1.5 mg/m^2 Eligible participants received topotecan 1.5 mg/m\^2 i.v. over 30 minutes daily for 5 consecutive days, every 3 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.
Part 1: Dose Evaluation (Up to Week 172) Withdrawal by Subject	1	0	0
Part 2: Randomized Study (Upto Week 197) Protocol Violation	0	1	0
Part 2: Randomized Study (Upto Week 197) Investigator decision	0	2	2
Part 2: Randomized Study (Upto Week 197) Lost to Follow-up	0	3	4
Part 2: Randomized Study (Upto Week 197) Withdrawal by Subject	0	18	14
Part 2: Randomized Study (Upto Week 197) Screen failure	0	0	1
Part 2: Randomized Study (Upto Week 197) Other	0	3	0

Baseline Characteristics

Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Irinotecan Liposome Injection 85 mg/m^2 n=5 Participants Participants received irinotecan liposome injection 85 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.	Part 1: Irinotecan Liposome Injection 70 mg/m^2 n=25 Participants Participants received irinotecan liposome injection 70 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.	Part 2: Irinotecan Liposome Injection 70 mg/m^2 n=229 Participants Eligible participants received irinotecan liposome injection 70 mg/m\^2 i.v. over 90 minutes, every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.	Part 2: Topotecan 1.5 mg/m^2 n=232 Participants Eligible participants received topotecan 1.5 mg/m\^2 i.v. over 30 minutes daily for 5 consecutive days, every 3 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.	Total n=491 Participants Total of all reporting groups
Age, Customized <65 years	4 Participants n=5 Participants	18 Participants n=7 Participants	128 Participants n=5 Participants	151 Participants n=4 Participants	301 Participants n=21 Participants
Age, Customized >=65 years	1 Participants n=5 Participants	7 Participants n=7 Participants	101 Participants n=5 Participants	81 Participants n=4 Participants	190 Participants n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	16 Participants n=7 Participants	79 Participants n=5 Participants	69 Participants n=4 Participants	166 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	9 Participants n=7 Participants	150 Participants n=5 Participants	163 Participants n=4 Participants	325 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	37 Participants n=5 Participants	36 Participants n=4 Participants	73 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants
Race/Ethnicity, Customized White	5 Participants n=5 Participants	25 Participants n=7 Participants	184 Participants n=5 Participants	182 Participants n=4 Participants	396 Participants n=21 Participants
Race/Ethnicity, Customized Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants	13 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	9 Participants n=4 Participants	17 Participants n=21 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	5 Participants n=5 Participants	20 Participants n=7 Participants	214 Participants n=5 Participants	218 Participants n=4 Participants	457 Participants n=21 Participants
Race/Ethnicity, Customized Not Reported/Unknown	0 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants	5 Participants n=4 Participants	17 Participants n=21 Participants

PRIMARY outcome

Timeframe: The TEAEs were reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration, approximately 680 days

Population: Part 1: Safety population included all enrolled participants who were treated with at least 1 dose of irinotecan liposome injection.

Outcome measures

Outcome measures
Measure	Part 1: Irinotecan Liposome Injection 85 mg/m^2 n=5 Participants Participants received irinotecan liposome injection 85 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.	Part 1: Irinotecan Liposome Injection 70 mg/m^2 n=25 Participants Participants received irinotecan liposome injection 70 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.
Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs) Any TEAE	5 Participants	25 Participants
Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs) Serious TEAEs	4 Participants	9 Participants

PRIMARY outcome

Timeframe: From the start of the first study treatment administration (Day 1) up to 14 days after the second dose of study treatment administration, a maximum of 42 days

Population: Part 1: Safety population included all enrolled participants who were treated with at least 1 dose of irinotecan liposome injection.

A TEAE was considered as DLT if it occurred during the safety evaluation period (i.e. first 28 days of treatment or 14 days after the second dose of study treatment if there was a treatment delay due to non-DLT related reasons) and were deemed related to the study treatment by the investigator. The determination of whether an Adverse Event was considered a Dose Limiting Toxicity was made by the Safety Review Committee (SRC) comprising the Part 1 Investigators and the Medical Monitor(s) of the Sponsor.

Outcome measures

Outcome measures
Measure	Part 1: Irinotecan Liposome Injection 85 mg/m^2 n=5 Participants Participants received irinotecan liposome injection 85 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.	Part 1: Irinotecan Liposome Injection 70 mg/m^2 n=25 Participants Participants received irinotecan liposome injection 70 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.
Part 1: Number of Participants With Dose-Limiting Toxicities (DLT)	4 Participants	2 Participants

PRIMARY outcome

Timeframe: From date of randomization (within 7 days before start of study treatment) until death. Assessed up to Part 2 primary analysis DCO date of 08 February 2022 (approximately 900 days)

Population: Part 2: The ITT population included all randomized participants.

The OS was defined as the time from randomization date to the date of death from any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. The OS was calculated using Kaplan-Meier technique. Following end of treatment participant and/or family was contacted by telephone every month to assess vital status.

Outcome measures

Outcome measures
Measure	Part 1: Irinotecan Liposome Injection 85 mg/m^2 n=229 Participants Participants received irinotecan liposome injection 85 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.	Part 1: Irinotecan Liposome Injection 70 mg/m^2 n=232 Participants Participants received irinotecan liposome injection 70 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.
Part 2: Overall Survival (OS)	7.92 months Interval 6.87 to 9.23	8.31 months Interval 7.33 to 9.13

SECONDARY outcome

Timeframe: RECIST assessments performed at Baseline (within 28 days before start of study treatment), every 6 weeks post first dose and treatment pause, 30 days after discontinuation of study treatment, then every month thereafter, approximately maximum of 1177 days

Population: Part 1: Safety population included all enrolled participants who were treated with at least 1 dose of irinotecan liposome injection.

The ORR was defined as the percentage of participants with a best overall response (BOR) characterized as either a complete response (CR) or partial response (PR) recorded from date of first dose of study treatment until documented PD or death. ORR analysis was based on BOR using RECIST v1.1 per investigator assessment. Per RECIST v1.1, CR is disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter of target lesions; and overall response = CR + PR. Per protocol, participants had computed tomography (CT)-scans and brain magnetic resonance imaging (MRI) every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy.

Outcome measures

Outcome measures
Measure	Part 1: Irinotecan Liposome Injection 85 mg/m^2 n=5 Participants Participants received irinotecan liposome injection 85 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.	Part 1: Irinotecan Liposome Injection 70 mg/m^2 n=25 Participants Participants received irinotecan liposome injection 70 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.
Part 1: Objective Response Rate (ORR)	40 percentage of participants Interval 5.27 to 85.34	44 percentage of participants Interval 24.4 to 65.07

SECONDARY outcome

Population: Part 1: Safety population included all enrolled participants who were treated with at least 1 dose of irinotecan liposome injection.

The PFS was defined as time from first dose of study treatment to the first documented objective PD using RECIST v1.1 or death due to any cause, whichever occurs first. Per RECIST 1.1, progression is defined as at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The PFS was calculated using Kaplan-Meier technique. Per protocol, participants had CT-scans and brain MRI every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy.

Outcome measures

Outcome measures
Measure	Part 1: Irinotecan Liposome Injection 85 mg/m^2 n=5 Participants Participants received irinotecan liposome injection 85 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.	Part 1: Irinotecan Liposome Injection 70 mg/m^2 n=25 Participants Participants received irinotecan liposome injection 70 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.
Part 1: Progression-Free Survival (PFS)	4.19 months Interval 1.58 to Upper limit of CI was not estimable due to insufficient number of participants with events at study closure.	3.98 months Interval 2.69 to 4.24

SECONDARY outcome

Timeframe: From Baseline (Day 1) until death. Assessed up to Part 1 DCO date of 11 August 2021 (approximately 1177 days)

Population: Part 1: Safety population included all enrolled participants who were treated with at least 1 dose of irinotecan liposome injection.

The OS was defined as the time from first dose of study treatment to the date of death from any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. The OS was calculated using Kaplan-Meier technique. Following end of treatment participant and/or family was contacted by telephone every month to assess vital status.

Outcome measures

Outcome measures
Measure	Part 1: Irinotecan Liposome Injection 85 mg/m^2 n=5 Participants Participants received irinotecan liposome injection 85 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.	Part 1: Irinotecan Liposome Injection 70 mg/m^2 n=25 Participants Participants received irinotecan liposome injection 70 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.
Part 1: OS	10.84 months Interval 0.99 to Upper limit of CI was not estimable due to insufficient number of participants with events at study closure.	8.08 months Interval 5.16 to 9.82

SECONDARY outcome

Population: Part 2: The ITT population included all randomized participants.

The PFS was defined as time from randomization to first documented objective PD using RECIST 1.1 (or response assessment in neuro-oncology brain metastases \[RANO-BM\] criteria for central nervous system \[CNS\] lesions) as assessed by blinded independent central review (BICR) or death due to any cause, whichever occurred first. Per RECIST 1.1, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The PFS was calculated using Kaplan-Meier technique. Per protocol, participants had CT-scans and brain MRI every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy.

Outcome measures

Outcome measures
Measure	Part 1: Irinotecan Liposome Injection 85 mg/m^2 n=229 Participants Participants received irinotecan liposome injection 85 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.	Part 1: Irinotecan Liposome Injection 70 mg/m^2 n=232 Participants Participants received irinotecan liposome injection 70 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.
Part 2: PFS	4.01 months Interval 2.96 to 4.17	3.25 months Interval 2.79 to 4.14

SECONDARY outcome

Population: Part 2: The ITT population included all randomized participants.

The ORR was defined as percentage of participants with a BOR characterized as either a CR or PR, recorded from randomization until documented PD or death relative to the total number of participants. ORR analysis was based on BOR assessed by BICR using RECIST v1.1. Per RECIST v1.1, CR is disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter of target lesions; and overall response = CR + PR. Per protocol, participants had CT-scans and brain MRI every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy.

Outcome measures

Outcome measures
Measure	Part 1: Irinotecan Liposome Injection 85 mg/m^2 n=229 Participants Participants received irinotecan liposome injection 85 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.	Part 1: Irinotecan Liposome Injection 70 mg/m^2 n=232 Participants Participants received irinotecan liposome injection 70 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.
Part 2: ORR	44.1 percentage of participants Interval 37.57 to 50.79	21.6 percentage of participants Interval 16.44 to 27.41

SECONDARY outcome

Population: Part 2: The ITT population included all randomized participants. Only participants with objective response were analyzed.

The DoR was defined as time from the first documented objective response (CR or PR, whichever was earlier) to the date of first documented PD or death due to any cause. The DoR analysis was based on BOR assessed by BICR using RECIST v1.1. Per RECIST v1.1, CR is disappearance of all target lesions and PR is \>=30% decrease in the sum of the longest diameter of target lesions. The DoR was calculated using Kaplan-Meier technique. Per protocol, participants had CT-scans and brain MRI every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy.

Outcome measures

Outcome measures
Measure	Part 1: Irinotecan Liposome Injection 85 mg/m^2 n=101 Participants Participants received irinotecan liposome injection 85 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.	Part 1: Irinotecan Liposome Injection 70 mg/m^2 n=50 Participants Participants received irinotecan liposome injection 70 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.
Part 2: Median Duration of Response (DoR)	4.14 months Interval 3.06 to 4.34	4.17 months Interval 2.86 to 4.76

SECONDARY outcome

Population: Part 2: The ITT population included all randomized participants. Only participants with objective response were analyzed.

Time to OR as per RECIST v1.1 criteria according to BICR was defined as time from the date of randomization to the date of first documented objective tumor response (CR or PR, whichever was first). Per RECIST v1.1, CR is disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter of target lesion. Participants with a new anti-cancer therapy prior to OR were censored at the last tumor assessment prior to new anti-cancer therapy. Per protocol, participants had CT-scans and brain MRI every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy.

Outcome measures

Outcome measures
Measure	Part 1: Irinotecan Liposome Injection 85 mg/m^2 n=101 Participants Participants received irinotecan liposome injection 85 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.	Part 1: Irinotecan Liposome Injection 70 mg/m^2 n=50 Participants Participants received irinotecan liposome injection 70 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.
Part 2: Median Time to Objective Response (OR)	1.68 months Interval 1.51 to 4.11	12.65 months Interval 8.41 to Upper limit of CI was not estimable due to insufficient number of participants with events at study closure.

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: Part 2: The ITT population included all randomized participants. Only participants analyzed at Week 12 are reported.

The EORTC QLQ-LC13 is a lung cancer specific module used in conjunction with EORTC QLQ-C30 and covers typical symptoms of lung cancer (cough, pain, dyspnea, sore mouth, peripheral neuropathy, hair loss). Scores range from 0-100 and a high score represents a high level of symptomatology/problems/worse QoL. Baseline was defined as the last non-missing measurement taken prior to reference start date. Change from baseline in dyspnea scale was calculated regardless of premature study treatment discontinuation. Participants completed these questionnaires on an electronic tablet every 6 weeks during treatment and it was continued until PD or commencement of new anti-neoplastic therapy.

Outcome measures

Outcome measures
Measure	Part 1: Irinotecan Liposome Injection 85 mg/m^2 n=106 Participants Participants received irinotecan liposome injection 85 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.	Part 1: Irinotecan Liposome Injection 70 mg/m^2 n=114 Participants Participants received irinotecan liposome injection 70 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)/Lung Cancer Supplement (LC13) Dyspnea Scale at Week 12	4.6 scores on a scale Standard Deviation 20.74	1.9 scores on a scale Standard Deviation 19.17

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: Part 2: The ITT population included all randomized participants. Only participants analyzed at Week 12 are reported.

The EORTC QLQ-LC13 is a lung cancer specific module used in conjunction with EORTC QLQ-C30 and covers typical symptoms of lung cancer (cough, pain, dyspnea, sore mouth, peripheral neuropathy, hair loss). Score ranges from 0-100 scale and a high score represents a high level of symptomatology/problems/worse QoL. Baseline was defined as the last non-missing measurement taken prior to reference start date. Change from baseline in cough scale was calculated regardless of premature study treatment discontinuation. Participants completed these questionnaires on an electronic tablet every 6 weeks during treatment and it was continued until PD or commencement of new anti-neoplastic therapy.

Outcome measures

Outcome measures
Measure	Part 1: Irinotecan Liposome Injection 85 mg/m^2 n=106 Participants Participants received irinotecan liposome injection 85 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.	Part 1: Irinotecan Liposome Injection 70 mg/m^2 n=114 Participants Participants received irinotecan liposome injection 70 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.
Change From Baseline in EORTC QLQ-LC13 Cough Scale at Week 12	1.6 scores on a scale Standard Deviation 25.77	-1.2 scores on a scale Standard Deviation 27.31

Adverse Events

Part 1: Irinotecan Liposome Injection 85 mg/m^2

Serious events: 4 serious events

Other events: 5 other events

Deaths: 5 deaths

Part 1: Irinotecan Liposome Injection 70 mg/m^2

Serious events: 9 serious events

Other events: 25 other events

Deaths: 23 deaths

Part 2: Irinotecan Liposome Injection 70 mg/m^2

Serious events: 106 serious events

Other events: 212 other events

Deaths: 201 deaths

Part 2: Topotecan 1.5 mg/m^2

Serious events: 88 serious events

Other events: 220 other events

Deaths: 205 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Director

Ipsen Bioscience, Inc.

Phone: see email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place