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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 is 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 (ICF) prior to the start of any study-specific qualification procedures.

Adults greater than or equal to (≥)18 years or the minimum legal adult age (whichever is greater) at the time the ICF 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 standard-of-care (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

Overall Survival (OS)

OS is defined as the time interval from the date of randomization to the date of death due to any cause.

Time frame
From the date of randomization to the date of death due to any cause, up to approximately 3.7 years

Secondary outcomes

1

Objective Response (OR) Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1)

Objective response as assessed by BICR is defined as the best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) per BICR according to RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.

Time frame
Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 3.7 years
2

Number of Participants With OR Assessed by Investigator Per RECIST v1.1

Objective response as assessed by the investigator is defined as a BOR of confirmed CR or confirmed PR by the investigator according to RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.

Time frame
Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 3.7 years
3

Progression-free Survival (PFS) as Assessed by BICR and Investigator

PFS is defined as the time interval from randomization to the earlier date of the first documented radiographic disease progression 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 3.7 years
4

Duration of Response (DoR) as Assessed by BICR and Investigator

DoR is defined as the time from the date of the first documentation of objective tumor response (CR or PR) that is subsequently confirmed to the date of the first documentation of objective tumor progressive or death to any cause, whichever occurs first. The DoR will be calculated for responding participants (PR or CR) only.

Time frame
From the date of first documentation of BOR (CR or PR) to the first documentation of objective progression or to death due to any cause, whichever occurs first, up to approximately 3.7 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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