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Antibody-Drug Conjugate
I-DXd for Small Cell Lung Cancer (IDeate-Lung01 Trial)
Phase 2
Recruiting
Research Sponsored by Daiichi Sankyo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Documentation of radiological disease progression on or after most recent systemic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 36 months
Awards & highlights
IDeate-Lung01 Trial Summary
This trial will help researchers understand how well and how safe DS-7300a works in people with lung cancer that has spread throughout the body and has not responded to other treatments.
Who is the study for?
This trial is for adults over 18 with ES-SCLC who've had at least one platinum-based treatment but no more than three prior therapies. They must have a measurable lesion not previously treated by radiation and show disease progression after the last therapy. Excluded are those with certain severe diseases, recent live vaccines, uncontrolled infections, or past hypersensitivity to similar drugs.Check my eligibility
What is being tested?
The study tests Ifinatamab Deruxtecan (I-DXd) in patients with ES-SCLC who've undergone previous chemotherapy. It aims to establish an effective dose based on safety and how the body processes the drug while assessing its ability to combat tumor growth.See study design
What are the potential side effects?
Potential side effects of I-DXd may include reactions related to infusion, lung issues like pneumonitis, liver problems due to hepatitis B or C infection risks, cardiovascular events such as strokes or heart attacks within six months before joining the trial.
IDeate-Lung01 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer has worsened after my last treatment.
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My cancer is small cell lung cancer confirmed by lab tests.
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I have a tumor that can be biopsied and it hasn't been treated with radiation.
IDeate-Lung01 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic procedure
Secondary outcome measures
Therapeutic procedure
Disease Control Rate (DCR) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
Therapeutic procedure
+10 moreIDeate-Lung01 Trial Design
2Treatment groups
Experimental Treatment
Group I: Ifinatamab Deruxtecan (8 mg/kg)Experimental Treatment1 Intervention
Participants will be randomized to receive I-DXd at 8 mg/kg.
Group II: Ifinatamab Deruxtecan (12 mg/kg)Experimental Treatment1 Intervention
Participants will be randomized to receive I-DXd at 12 mg/kg.
In Part 2, all participants will receive I-DXd 12 mg/kg.
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Who is running the clinical trial?
Daiichi SankyoLead Sponsor
392 Previous Clinical Trials
416,185 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,491 Total Patients Enrolled
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
420,117 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.I am 18 years old or older.I have received at least two cycles of platinum-based chemotherapy for extensive-stage disease.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.I have a serious eye condition affecting my cornea.I haven't had a stroke, mini-stroke, or blood clot in the arteries in the last 6 months.My cancer has worsened after my last treatment.I have or had lung inflammation not caused by infection, treated with steroids.I haven't had cancer, except for certain skin, in situ, GI tract, or bladder cancers, in the last 3 years.I have brain metastases or spinal issues that are untreated or causing symptoms.My cancer is small cell lung cancer confirmed by lab tests.I have a tumor that can be biopsied and it hasn't been treated with radiation.I have not been treated with orlotamab, enoblituzumab, or similar drugs.I have severe lung problems due to other lung diseases.I do not have any uncontrolled infections including HIV.I do not have active or uncontrolled hepatitis B or C.You have at least one spot that can be measured by the doctor using specific guidelines.I have serious heart problems that are not under control.I have an autoimmune disease.I have not received a live vaccine in the last 30 days.I have had a transplant of bone marrow, stem cells, or an organ.I do not have any severe illnesses or conditions that are not under control.I am on a low dose of steroids, not exceeding 10 mg of prednisone daily, except for asthma, COPD, or mild skin conditions.I have side effects from cancer treatment that haven't improved to mild or gone back to how they were before treatment.I have been treated with a specific type of cancer drug linked to a toxin (like trastuzumab deruxtecan).You have had a strong allergic reaction to the study drug or its ingredients.
Research Study Groups:
This trial has the following groups:- Group 1: Ifinatamab Deruxtecan (8 mg/kg)
- Group 2: Ifinatamab Deruxtecan (12 mg/kg)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the lofty goals of this experiment?
"The primary outcome that will be measured over a period of up to 24 months is the percentage of participants with objective response rate (ORR) based on blinded independent central review (BICR) following treatment with DS-7300a in participants with pretreated ES-SCLC. Additionally, this trial will be evaluating secondary outcomes including progression-free survival (PFS) following treatment with I-DXd in participants with pretreated ES-SCLC, which is defined as the time interval from the date of enrollment to the date of disease progression based on RECIST v1.1 criteria or death due to any"
Answered by AI
Is there a danger in taking DS-7300a regularly?
"DS-7300a is a medication that is currently being trialed in Phase 2 clinical trials. While there is some evidence that the drug is safe, its efficacy has not yet been proven."
Answered by AI
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