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A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer

PHASE3RECRUITING

This study was designed to compare the efficacy and safety of I-DXd with treatment of physician's choice in participants with relapsed small cell lung cancer (SCLC).

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Study details:

The primary objective of this study is to assess whether treatment with I-DXd improves objective response rate (ORR) and prolongs overall survival (OS) compared with treatment of physician's choice among participants with relapsed SCLC. The secondary objectives of the study are to further evaluate the efficacy/safety of I-DXd, health economics and outcome research measures (including patient reported outcomes), immunogenicity of I-DXd, B7-H3 protein expression, and characterize the pharmacokinetics of I-DXd.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Sign and date the informed consent form prior to the start of any study-specific qualification procedures.

Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time the informed consent form is signed.

Has histologically or cytologically documented SCLC.

The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content.

Has received prior therapy with only one prior platinum-based line as systemic therapy for SCLC with at least 2 cycles of therapy and a chemotherapy-free interval of >30 days.

Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator.

Has documentation of radiological disease progression on or after the most recent systemic therapy.

Has ECOG PS of ≤1.

Subjects with untreated and asymptomatic brain metastases or subjects with treated brain metastases that are no longer symptomatic (ie, without neurologic signs or symptoms) and who require no treatment with steroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. Subjects must have a stable neurologic status for at least 2 weeks prior to the first dose of study drug.

Exclusion criteria

Has received prior treatment with orlotamab, enoblituzumab, or other humanized anti-B7 homologue 3 (B7-H3) targeted agents, including I-DXd.

Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities.

Has received any of the comparators used in this study or any topoisomerase I inhibitor.

Has inadequate washout period before randomization as specified in the protocol.

Has any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event.

Has uncontrolled or significant cardiovascular disease.

Has clinically significant corneal disease.

Has history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at Screening.

Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders, prior pneumonectomy, or requirement for supplemental oxygen.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-05-21

Primary completion: 2027-04-30

Study completion finish: 2029-02-22

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT06203210

Intervention or treatment

DRUG: Ifinatamab deruxtecan

DRUG: Topotecan

DRUG: Amrubicin

DRUG: Lurbinectedin

Conditions

• Small Cell Lung Cancer

Condition: Small Cell Lung Cancer
DRUG: Ifinatamab deruxtecan and other drugs
Ballarat, Not Specified, Australia and more
Sponsor: Daiichi Sankyo

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Find a site

Closest Location:

Ballarat Base Hospital

Research sites nearby

Select from list below to view details:

Ballarat Base Hospital
Ballarat, Not Specified, Australia
Flinders Medical Centre (Fmc)
Bedford Park, Not Specified, Australia
Chris Oâbrien Lifehouse
Camperdown, Not Specified, Australia
Sunshine Hospital
St Albans, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Ifinatamab deruxtecan (I-DXd) Participants randomized to receive 12 mg/kg I-DXd monotherapy on Day 1 of each 21-day cycle until unacceptable toxicity, progressive disease (PD), or withdrawal of consent as specified in the protocol.	DRUG: Ifinatamab deruxtecan 12 mg/kg intravenous dose on Day 1 of each 21-day cycle
ACTIVE_COMPARATOR: Treatment of Physician's Choice (TPC) Participants randomized to receive topotecan, lurbinectedin, or amrubicin, as per investigator's choice and per locally approved label (indicated dose and frequency), until a treatment discontinuation criterion is met as specified in the protocol.	DRUG: Topotecan Topotecan will be administered per local SoC.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Number of Participants With Objective Response Rate Assessed by Blinded Independent Central Review	Confirmed objective response rate (ORR) is defined as the sum of the complete response (CR) rate and partial response (PR) rate based on BICR by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.	Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 4.5 years
Overall Survival	Not Specified	From the date of randomization to the date of death due to any cause, whichever occurs first, up to approximately 4.5 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Number of Participants With Objective Response Rate Assessed by Investigator	Confirmed objective response rate (ORR) is defined as the sum of the complete response (CR) rate and partial response (PR) rate based on investigator by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.	Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 4.5 years
Progression-free Survival As Assessed by Blinded Independent Central Review and Investigator	PFS is defined as the time interval from the date of randomization to the date of disease progression as per BICR and investigator assessment or death due to any cause.	Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 4.5 years
Duration of Response As Assessed by Blinded Independent Central Review and Investigator	Duration of response (DoR) is defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first documentation of progressive disease (PD) or death. The DoR will be calculated for responding participants (PR or CR) only.	From the date of first documentation of confirmed response (CR or PR) to the first documentation of objective progression or to death due to any cause, whichever occurs first, up to approximately 4.5 years
Disease Control Rate As Assessed by Blinded Independent Central Review and Investigator	Disease control rate is defined as the proportion of participants who have achieved a best overall response of confirmed CR, confirmed PR, or SD (or non-CR/non-PD) by BICR and investigator assessment per RECIST v1.1.	Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 4.5 years
Time to Response As Assessed by Blinded Independent Central Review and Investigator	TTR is defined as the time from the date of randomization to the first documentation of objective tumor response (CR or PR) that is subsequently confirmed by BICR and investigator assessment .Time to response (TTR) will be calculated for confirmed responders only.	From the start date of study drug to the date of the first documentation of response (CR or PR) that is subsequently confirmed, up to approximately 4.5 years
Change from Baseline in The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30	This 30-item questionnaire assesses global health status (GHS)/quality of life (QoL), subject functioning, and general cancer symptoms and has a recall period of one week. All scores for the EORTC QLQ-C30 instrument are linearly transformed to a 0 to 100 metric, where a higher score on GHS/QoL and functioning scales indicates a better outcome and a higher score for the symptom scales indicates worse outcomes.	Baseline up to 4.5 years
Change from Baseline in The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 29 (EORTC QLQ-LC29)	The LC29 is a self-reported 29-item questionnaire that measures SCLC-related symptoms and the side effects of treatments and has a recall period of one week. All scores range from 0 to 100, with a higher score indicating a worse outcome.	Baseline up to 4.5 years
Overall Number of Participants With Treatment-emergent Adverse Events Following I-DXd Monotherapy	TEAEs are assessed based on NCI CTCAE v5.0.	Baseline up to 4.5 years
The Number of Participants Who Are Anti-Drug Antibody (ADA)-Positive At Any Time and Who Have A Treatment-emergent Anti-Drug Antibody	The ADA prevalence, which is the percentage of participants who are ADA positive at any time point (baseline or post-baseline), as well as the ADA incidence, which is the proportion of participants having treatment-emergent ADA during the study period, will only be reported in participants receiving I-DXd.	Baseline up to 4.5 years
Pharmacokinetic Parameter Maximum Concentration for I-DXd, Total Anti-B7-H3 Antibody, and MAAA-1181a	Maximum concentration (Cmax) will be assessed using non-compartmental methods in participants randomized to the I-DXd group.	Cycle 1 before infusion (BI), end of infusion EOI), and 3, 6, 24, 72, 168, 336, and 504 hours (hrs) post dose; Cycle 2 BI and EOI; Cycle 3 BI, EOI, and 6 hrs postdose; Cycles 4, 5, and every 2 cycles thereafter up to 4.5 years BI (each cycle is 21 days)
Pharmacokinetic Parameter Time to Maximum Concentration for I-DXd, Total Anti-B7-H3 Antibody, and MAAA-1181a	Time to maximum concentration (Tmax) will be assessed using non-compartmental methods in participants randomized to the I-DXd group.	Cycle 1 before infusion (BI), end of infusion EOI), and 3, 6, 24, 72, 168, 336, and 504 hours (hrs) post dose; Cycle 2 BI and EOI; Cycle 3 BI, EOI, and 6 hrs postdose; Cycles 4, 5, and every 2 cycles thereafter up to 4.5 years BI (each cycle is 21 days)
Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve for I-DXd, Total Anti-B7-H3 Antibody, and MAAA-1181a	Area under the plasma concentration-time curve up to the last quantifiable time point (AUClast) and area under the plasma concentration-time curve dosing interval (AUCtau) will be assessed using non-compartmental methods in participants randomized to the I-DXd group.	Cycle 1 before infusion (BI), end of infusion EOI), and 3, 6, 24, 72, 168, 336, and 504 hours (hrs) post dose; Cycle 2 BI and EOI; Cycle 3 BI, EOI, and 6 hrs postdose; Cycles 4, 5, and every 2 cycles thereafter up to 4.5 years BI (each cycle is 21 days)

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References

Clinical Trials Gov: A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer