Trial · NCT03088813

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

NCT03088813, Phase 3, Completed, Ipsen; results first posted 2023-10-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer. Trials, record NCT03088813. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03088813

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer
NCT number: NCT03088813
Status: Completed
Phases: Phase 3
Enrollment: 491 participants, actual
Lead sponsor: Ipsen
Conditions: Small Cell Lung Cancer
Interventions: Irinotecan liposome injection, Topotecan
First posted: 2017-03-23
Last updated: 2025-02-19
Other registries' IDs: eudract:2017-004261-26
Results first posted: 2023-10-17

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)	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	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.
Primary	Part 1: Number of Participants With Dose-Limiting Toxicities (DLT)	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	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.
Primary	Part 2: Overall Survival (OS)	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)	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.
Secondary	Part 1: Objective Response Rate (ORR)	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	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.
Secondary	Part 1: Progression-Free Survival (PFS)	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	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.
Secondary	Part 1: OS	From Baseline (Day 1) until death. Assessed up to Part 1 DCO date of 11 August 2021 (approximately 1177 days)	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.
Secondary	Part 2: PFS	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 900 days	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.
Secondary	Part 2: ORR	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 900 days	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.
Secondary	Part 2: Median Duration of Response (DoR)	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 900 days	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.
Secondary	Part 2: Median Time to Objective Response (OR)	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 900 days	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.

1 to 10 of 12Source ClinicalTrials.gov

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Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)	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	Part 1: Safety population included all enrolled participants who were treated with at least 1 dose of irinotecan liposome injection.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Part 1: Number of Participants With Dose-Limiting Toxicities (DLT)	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	Part 1: Safety population included all enrolled participants who were treated with at least 1 dose of irinotecan liposome injection.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Part 2: Overall Survival (OS)	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)	Part 2: The ITT population included all randomized participants.	months	MEDIAN
SECONDARY	Part 1: Objective Response Rate (ORR)	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	Part 1: Safety population included all enrolled participants who were treated with at least 1 dose of irinotecan liposome injection.	percentage of participants	NUMBER
SECONDARY	Part 1: Progression-Free Survival (PFS)	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	Part 1: Safety population included all enrolled participants who were treated with at least 1 dose of irinotecan liposome injection.	months	MEDIAN
SECONDARY	Part 1: OS	From Baseline (Day 1) until death. Assessed up to Part 1 DCO date of 11 August 2021 (approximately 1177 days)	Part 1: Safety population included all enrolled participants who were treated with at least 1 dose of irinotecan liposome injection.	months	MEDIAN
SECONDARY	Part 2: PFS	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 900 days	Part 2: The ITT population included all randomized participants.	months	MEDIAN
SECONDARY	Part 2: ORR	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 900 days	Part 2: The ITT population included all randomized participants.	percentage of participants	NUMBER
SECONDARY	Part 2: Median Duration of Response (DoR)	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 900 days	Part 2: The ITT population included all randomized participants. Only participants with objective response were analyzed.	months	MEDIAN
SECONDARY	Part 2: Median Time to Objective Response (OR)	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 900 days	Part 2: The ITT population included all randomized participants. Only participants with objective response were analyzed.	months	MEDIAN

1 to 10 of 12Source ClinicalTrials.gov

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Results by group26

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)	Part 1: Irinotecan Liposome Injection 85 mg/m^2	Any TEAE	5		Participants
Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)	Part 1: Irinotecan Liposome Injection 70 mg/m^2	Any TEAE	25		Participants
Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)	Part 1: Irinotecan Liposome Injection 85 mg/m^2	Serious TEAEs	4		Participants
Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)	Part 1: Irinotecan Liposome Injection 70 mg/m^2	Serious TEAEs	9		Participants
Part 1: Number of Participants With Dose-Limiting Toxicities (DLT)	Part 1: Irinotecan Liposome Injection 85 mg/m^2		4		Participants
Part 1: Number of Participants With Dose-Limiting Toxicities (DLT)	Part 1: Irinotecan Liposome Injection 70 mg/m^2		2		Participants
Part 2: Overall Survival (OS)	Part 2: Irinotecan Liposome Injection 70 mg/m^2		7.92	95% Confidence Interval 6.87 to 9.23	months
Part 2: Overall Survival (OS)	Part 2: Topotecan 1.5 mg/m^2		8.31	95% Confidence Interval 7.33 to 9.13	months
Part 1: Objective Response Rate (ORR)	Part 1: Irinotecan Liposome Injection 85 mg/m^2		40	95% Confidence Interval 5.27 to 85.34	percentage of participants
Part 1: Objective Response Rate (ORR)	Part 1: Irinotecan Liposome Injection 70 mg/m^2		44	95% Confidence Interval 24.40 to 65.07	percentage of participants

1 to 10 of 26Source ClinicalTrials.gov

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Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Part 1: Dose Evaluation (Up to Week 172)	STARTED	Part 1: Irinotecan Liposome Injection 85 Milligrams/Meter Square (mg/m^2)	5
Part 1: Dose Evaluation (Up to Week 172)	STARTED	Part 1: Irinotecan Liposome Injection 70 mg/m^2	25
Part 1: Dose Evaluation (Up to Week 172)	STARTED	Part 2: Irinotecan Liposome Injection 70 mg/m^2	0
Part 1: Dose Evaluation (Up to Week 172)	STARTED	Part 2: Topotecan 1.5 mg/m^2	0
Part 1: Dose Evaluation (Up to Week 172)	COMPLETED	Part 1: Irinotecan Liposome Injection 85 Milligrams/Meter Square (mg/m^2)	5
Part 1: Dose Evaluation (Up to Week 172)	COMPLETED	Part 1: Irinotecan Liposome Injection 70 mg/m^2	24
Part 1: Dose Evaluation (Up to Week 172)	COMPLETED	Part 2: Irinotecan Liposome Injection 70 mg/m^2	0
Part 1: Dose Evaluation (Up to Week 172)	COMPLETED	Part 2: Topotecan 1.5 mg/m^2	0
Part 1: Dose Evaluation (Up to Week 172)	NOT COMPLETED	Part 1: Irinotecan Liposome Injection 85 Milligrams/Meter Square (mg/m^2)	0
Part 1: Dose Evaluation (Up to Week 172)	NOT COMPLETED	Part 1: Irinotecan Liposome Injection 70 mg/m^2	1

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Adverse events700

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Part 1: Irinotecan Liposome Injection 85 mg/m^2	2	5	7
other	Anaemia	Blood and lymphatic system disorders	Part 1: Irinotecan Liposome Injection 70 mg/m^2	7	25	11
other	Anaemia	Blood and lymphatic system disorders	Part 2: Irinotecan Liposome Injection 70 mg/m^2	82	226	193
other	Anaemia	Blood and lymphatic system disorders	Part 2: Topotecan 1.5 mg/m^2	177	223	773
other	Neutropenia	Blood and lymphatic system disorders	Part 1: Irinotecan Liposome Injection 85 mg/m^2	3	5	3
other	Neutropenia	Blood and lymphatic system disorders	Part 1: Irinotecan Liposome Injection 70 mg/m^2	4	25	7
other	Neutropenia	Blood and lymphatic system disorders	Part 2: Irinotecan Liposome Injection 70 mg/m^2	41	226	124
other	Neutropenia	Blood and lymphatic system disorders	Part 2: Topotecan 1.5 mg/m^2	137	223	532
other	Thrombocytopenia	Blood and lymphatic system disorders	Part 1: Irinotecan Liposome Injection 85 mg/m^2	0	5	0
other	Thrombocytopenia	Blood and lymphatic system disorders	Part 1: Irinotecan Liposome Injection 70 mg/m^2	4	25	11

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Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Part 1: Irinotecan Liposome Injection 85 mg/m^2	5	5
Total, all-cause mortality	Part 1: Irinotecan Liposome Injection 70 mg/m^2	23	25
Total, all-cause mortality	Part 2: Irinotecan Liposome Injection 70 mg/m^2	201	226
Total, all-cause mortality	Part 2: Topotecan 1.5 mg/m^2	205	223
Total, other adverse events	Part 1: Irinotecan Liposome Injection 85 mg/m^2	5	5
Total, other adverse events	Part 1: Irinotecan Liposome Injection 70 mg/m^2	25	25
Total, other adverse events	Part 2: Irinotecan Liposome Injection 70 mg/m^2	212	226
Total, other adverse events	Part 2: Topotecan 1.5 mg/m^2	220	223
Total, serious adverse events	Part 1: Irinotecan Liposome Injection 85 mg/m^2	4	5
Total, serious adverse events	Part 1: Irinotecan Liposome Injection 70 mg/m^2	9	25

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Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
35195913	DERIVED	PubMed
38648575	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Part 1: Irinotecan Liposome Injection 85 mg/m^2 vs Part 1: Irinotecan Liposome Injection 70 mg/m^2: Part 1: Number of Participants With Dose-Limiting Toxicities (DLT)

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03088813

GET https://conductscience.org/api/trials/v1/NCT03088813/results?page=2

API reference For AI assistants