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A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer (IDeate-Lung02)

Daiichi Sankyo logo

Daiichi Sankyo

Status and phase

Enrolling
Phase 3

Conditions

Small Cell Lung Cancer

Treatments

Drug: Topotecan
Drug: Amrubicin
Drug: Lurbinectedin
Drug: Ifinatamab deruxtecan

Study type

Interventional

Funder types

Industry

Identifiers

NCT06203210
DS7300-188
2023-509628-16 (Other Identifier)

Details and patient eligibility

About

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).

Full description

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.

Enrollment

468 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Participants must meet all the following criteria to be eligible for randomization into the study:

  1. Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
  2. Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time the informed consent form is signed.
  3. Has histologically or cytologically documented SCLC.
  4. The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content.
  5. 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.
  6. Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator.
  7. Has documentation of radiological disease progression on or after the most recent systemic therapy.
  8. Has ECOG PS of ≤1.
  9. 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

Participants who meet any of the following criteria will be disqualified from entering the study:

  1. Has received prior treatment with orlotamab, enoblituzumab, or other humanized anti-B7 homologue 3 (B7-H3) targeted agents, including I-DXd.
  2. Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities.
  3. Has received any of the comparators used in this study or any topoisomerase I inhibitor.
  4. Has inadequate washout period before randomization as specified in the protocol.
  5. Has any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event.
  6. Has uncontrolled or significant cardiovascular disease.
  7. Has clinically significant corneal disease.
  8. 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.
  9. 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

468 participants in 2 patient groups

Ifinatamab deruxtecan (I-DXd)
Experimental group
Description:
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.
Treatment:
Drug: Ifinatamab deruxtecan
Treatment of Physician's Choice (TPC)
Active Comparator group
Description:
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.
Treatment:
Drug: Lurbinectedin
Drug: Amrubicin
Drug: Topotecan

Trial contacts and locations

221

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Central trial contact

Daiichi Sankyo Contact for Clinical Trial Information

Data sourced from clinicaltrials.gov

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