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A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03)

ConditionExtensive Stage-small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaiichi Sankyo

About this trial

This study is designed to evaluate the safety and efficacy of ifinatamab deruxtecan (I-DXd) in combination with immune checkpoint inhibitor (ICI) atezolizumab with or without carboplatin in participants with extensive stage-small cell lung cancer (ES-SCLC) in the first-line (1L) setting.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Sign and date the informed consent form (ICF), 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 ICF is signed.

Has histologically or cytologically confirmed diagnosis of ES-SCLC who will require first-line (IL) therapy.

For Cohort 1, participant has received 4 cycles of 1L induction therapy with carboplatin, etoposide, and atezolizumab for ES-SCLC with ongoing CR PR, CR, or SD per RECIST v1.1 assessed by the investigator.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ifinatamab deruxtecan

    Drug

    Intravenous administration

  • Atezolizumab

    Drug

    Intravenous administration

  • Carboplatin

    Drug

    Intravenous administration

Treatment groups

123 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Cohort 1, Part A: Maintenance Only (I-DXd 12 mg/kg)Experimental treatment 2 interventions
Group B: Cohort 2, Part A: Induction + Maintenance (I-DXd 8 mg/kg)Experimental treatment 3 interventions
Group C: Cohort 2, Part A: Induction + Maintenance (I-DXd 12 mg/kg)Experimental treatment 3 interventions
Group D: Cohort 1, Part B: Maintenance (I-DXd 8 mg/kg)Experimental treatment 2 interventions
Group E: Cohort 1, Part B: Maintenance (I-DXd 12 mg/kg)Experimental treatment 2 interventions
Group F: Cohort 2, Part B: Induction + Maintenance (I-DXd 8 mg/kg)Experimental treatment 3 interventions
Group G: Cohort 2, Part B: Induction + Maintenance (I-DXd 12 mg/kg)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Number of Participants Reporting Dose-limiting Toxicities Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A)

Time frame
Cycle 1 Day 1 up to Cycle 1 Day 21 (each cycle is 21 days)
2

Overall Number of Participants With Treatment-emergent Adverse Events Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B)

Time frame
Baseline up to 37 months

Secondary outcomes

1

Progression-free Survival As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B)

Progression-free survival is defined as the time from the enrollment/randomization date to the earlier of the dates of the first documentation of disease progression assessed by BICR and investigator per RECIST v1.1 or death due to any cause.

Time frame
From start date of study drug to the earlier date of the first objective documentation of radiographic disease progression assessed by BICR and investigator per RECIST v1.1 or death due to any cause, whichever occurs first, up to approximately 37 months
2

Objective Response Rate Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With Carboplatin (Part A and B of Cohort 2 Only)

Objective response rate (ORR) is defined as proportion of subjects who achieved a best overall response of confirmed complete response (CR) or confirmed partial response (PR) per BICR and investigator according to RECIST v1.1.

Time frame
Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 37 months
3

Duration of Response As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With Carboplatin (Part A and B of Cohort 2 Only)

Duration of response (DoR) is defined as the time from the date of the first documentation of objective response (confirmed complete response \[CR\] or confirmed partial response \[PR\]) to the date of the first documentation of progressive disease (PD) or death due to any cause, whichever occurs first. The DoR will be calculated for responding participants (confirmed PR or confirmed 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 37 months
4

Disease Control Rate As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With Carboplatin (Part A and B of Cohort 2 Only)

Disease control rate is defined as the proportion of participants who have achieved a best overall response of confirmed CR, confirmed PR, or SD 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 37 months

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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