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Antibody-drug Conjugate

Ifinatamab Deruxtecan for Small Cell Lung Cancer (IDeate-Lung02 Trial)

Phase 3

Recruiting

Research Sponsored by Daiichi Sankyo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have ECOG PS of ≤1

Participants must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content

Must not have

Participants who have uncontrolled or significant cardiovascular disease

Participants who have clinically significant corneal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 4.5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

"This trial aimed to see if a new treatment, I-DXd, is better and safer than the usual treatments for patients with small cell lung cancer that has come back."

Who is the study for?

This trial is for adults over 18 with relapsed Small Cell Lung Cancer who've had at least one platinum-based treatment. They must have a good performance status, measurable cancer growth after recent therapy, and can have treated brain metastases if they're symptom-free.

What is being tested?

The study compares Ifinatamab Deruxtecan (I-DXd), a new drug, against the physician's choice of Topotecan, Lurbinectedin or Amrubicin in patients with relapsed SCLC to see which is more effective and safer.

What are the potential side effects?

Potential side effects include reactions related to infusion of I-DXd such as fatigue, nausea, hair loss; similar side effects may occur with other drugs used like Topotecan.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active and can carry on all pre-disease activities without restriction.

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I can provide a sample of my tumor that is large and high-quality enough for testing.

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My small cell lung cancer is confirmed by lab tests.

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My cancer has worsened after my last treatment.

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I am at least 18 years old or the legal adult age in my country.

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I've had one platinum-based treatment for small cell lung cancer and no chemo for over 30 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have serious heart problems.

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I have a serious eye condition affecting my cornea.

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I have not been treated with orlotamab, enoblituzumab, or similar drugs targeting B7-H3.

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I have not taken any drugs similar to those in this study or topoisomerase I inhibitors.

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I haven't had a stroke, mini-stroke, or blood clot in my arteries in the last 6 months.

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I stopped an exatecan-based drug due to side effects.

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I have severe lung problems or need extra oxygen.

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I have or had lung inflammation not caused by an infection and needed steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 4.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 4.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 4.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Objective Response Rate Assessed by Blinded Independent Central Review

Secondary study objectives

Change from Baseline in The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30

Change from Baseline in The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 29 (EORTC QLQ-LC29)

Disease Control Rate As Assessed by Blinded Independent Central Review and Investigator

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Ifinatamab deruxtecan (I-DXd)Experimental Treatment1 Intervention

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.

Group II: Treatment of Physician's Choice (TPC)Active Control3 Interventions

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.

0 / 14Eligibility criteria met