Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

All Drugs and Chemicals

Antibodies

Immunoglobulins

Rovalpituzumab tesirine

Immunoconjugates

Immunologic Factors

0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (every 6 weeks; Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.

Rovalpituzumab tesirine is a DLL3 targeted antibody drug conjugate (ADC).

AbbVie Inc.

The purpose of this study is to determine the efficacy of rovalpituzumab tesirine as a third-line and later treatment for participants with relapsed or refractory delta-like protein 3 (DLL3) expressing small cell lung cancer (SCLC).

Study of Rovalpituzumab Tesirine (SC16LD6.5) for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer

An Open-label, Single-Arm, Phase 2 Study Evaluating the Efficacy, Safety and Pharmacokinetics of Rovalpituzumab Tesirine (SC16LD6.5) for Third-line and Later Treatment of Subjects With Relapsed or Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer (TRINITY)

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Objective response is defined as a participant with the best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1, prior to receiving any subsequent anticancer therapy and retreatment, and is confirmed by a consecutive response assessment at least 4 weeks (28 days) from the initial determination of CR/PR. Analyzed based on response assessments from both the Independent Review Committee (IRC) and investigators.

CR: disappearance of all target lesions.Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Overall survival is defined as the time from the first dose date to death for any reason. Participants who were alive at the clinical data cut-off were censored at the last known alive date. Based on Kaplan-Meier estimates.

Overall response rate is defined as the percentage of participants with a response of CR or PR, regardless of confirmation, per RECIST v 1.1 prior to receiving any subsequent anticancer therapy and retreatment. Any participants not exhibiting a response (CR or PR) as defined above were considered non-responders. Analyzed based on response assessments from both the IRC and investigators.

CR: disappearance of all target lesions.Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Duration of objective response is defined as the time from the date of first documented CR or PR of participants with a confirmed response to the documented date of progressive disease (PD) or death, whichever occurred first. Participants who neither progressed nor died are censored at the last evaluable disease assessment. Analyzed based on response assessments from both the IRC and investigators. Based on Kaplan-Meier estimates.

CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. (The appearance of one or more new lesions is also considered progression.)

Progression-free survival is defined as the time from the first dose date to the documented date of PD or death, whichever occurred first. Participants who neither progressed nor died were censored at the last evaluable disease assessment. Analyzed based on response assessments from both the IRC and investigators. Based on Kaplan-Meier estimates.

PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. (The appearance of one or more new lesions is also considered progression.)

Clinical benefit rate is defined as the percentage of participants with an overall response of CR or PR or stable disease (SD) with SD of a minimum duration of 42 days from the first dose date. Analyzed based on response assessments from both the IRC and investigators.

CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. (The appearance of one or more new lesions is also considered progression.)

Duration of clinical benefit is defined as time from the date of first documented CR or PR or SD of ≥ 42 days from first dose date (-7 days to allow for scheduled visit window per the protocol) to the documented date PD or death, whichever occurs first. Analyzed based on response assessments from both the IRC and investigators.

CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

An adverse event (AE) is defined as any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that at any dose: is fatal or life-threatening; results in death or hospitalization; is disabling/incapacitating or a congenital anomaly/birth defect; is medically significant. AE severity was graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03 terminology: grade 1=mild; grade 2=moderate; grade 3=severe; grade 4 life-threatening; grade 5=death. TEAEs were defined as AEs that were newly occurring or worsened following study treatment.

TEAEs were defined as AEs that were newly occurring or worsened following study treatment.

AbbVie

0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.

Rovalpituzumab Tesirine

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Global Medical Services

Investigator

'DLL3 High' (tumors with ≥75% of cells expressing DLL3) participants received 0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.

Rovalpituzumab Tesirine: DLL3 High

'DLL3 Positive' (tumors with ≥25% of cells expressing DLL3) participants received 0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.

Rovalpituzumab Tesirine: DLL3 Positive

Modified Intent to Treat Population: all participants who received any amount of study drug.

Objective Response Rate

Overall Survival

Overall Response Rate

Modified Intent to Treat Population: all participants who received any amount of study drug and had an objective response.

Duration of Objective Response

Progression-Free Survival

Clinical Benefit Rate

Modified Intent to Treat Population: all participants who received any amount of study drug with best overall response of CR or PR or SD.

Duration of Clinical Benefit

Cycle 1: Day 1, 30 minutes pre-infusion

Cycle 1: Day 1, 30 minutes post-infusion

Cycle 1: Day 3

Cycle 1: Day 15

Cycle 1: Day 29

Cycle 2: Day 1, 30 minutes pre-infusion

Cycle 2: Day 1, 30 minutes post-infusion

Cycle 2: Day 3

Cycle 2: Day 15

Cycle 2: Day 29

End of Treatment

0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (Q6W) for 2 cycles.

Rovalpituzumab Tesirine: Initial Treatment Period

0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of retreatment Cycle 1

Rovalpituzumab Tesirine: Re-Treatment 1

0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of retreatment Cycle 2

Rovalpituzumab Tesirine: Re-Treatment 2

Pharmacokinetic Analysis Population: all participants who receive at least 1 dose of study treatment and at least 1 post-baseline blood sample following a dose of study treatment and had an assessment at given time point.

Rovalpituzumab Tesirine Antibody-Drug Conjugate Plasma Concentrations by Study Visit

Positive at Any Study Visit

Positive After First Dose of Study Drug

All participants who received rovalpituzumab tesirine and had at least one sample screened for ATA against rovalpituzumab tesirine antibody-drug conjugate concentration.

Number of Anti-Therapeutic Antibody (ATA) Positive Participants

Any TEAE

Treatment Emergent SAE

TEAE Maximum Severity Grade 3/4

TEAE Leading to Drug WIthdrawal

TEAE Leading to Dose Interruption

TEAE Leading to Dose Reduction

TEAE Reasonably Possibly Related to Study Drug

Fatal AE

Safety analysis population: all participants who received any amount of study drug.

Spots Global Cancer Trial Database for Study of Rovalpituzumab Tesirine (SC16LD6.5) for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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