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

ConditionSmall Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaiichi Sankyo

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 extensive-stage small cell lung cancer (ES-SCLC).

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

Disqualifiers

Has received prior treatment with orlotamab, enoblituzumab, or other 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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ifinatamab deruxtecan

    Drug

    12 mg/kg intravenous dose on Day 1 of each 21-day cycle

  • Topotecan

    Drug

    Topotecan will be administered per local SoC.

  • Amrubicin

    Drug

    Amrubicin will be administered per local SoC.

  • Lurbinectedin

    Drug

    Lurbinectedin will be administered per local SoC

Treatment groups

540 Participants
are divided into 2 treatment groups
Group A: Ifinatamab deruxtecan (I-DXd)Experimental treatment 1 intervention
Group B: Treatment of Physician's Choice (TPC)Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
2

Overall Survival

Time frame
From the date of randomization to the date of death due to any cause, up to approximately 5 years

Secondary outcomes

1

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.

Time frame
Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
2

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.

Time frame
Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
3

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.

Time frame
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 5 years
4

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.

Time frame
Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daiichi Sankyo

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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