What side effects are associated with this type of intervention?

Common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy regimens such as etoposide combined with either cisplatin or carboplatin. Known side effects of these treatments include neutropenia, anemia, nausea, vomiting, and fatigue. For antibody-drug conjugates like Ifinatamab Deruxtecan, side effects can include myelosuppression (neutropenia, anemia, thrombocytopenia), interstitial lung disease, and gastrointestinal symptoms such as nausea and diarrhea. These side effects are consistent with those observed in other ADCs used in cancer treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for Small Cell Lung Cancer (SCLC), including immunotherapy agents like atezolizumab and durvalumab, which are often combined with chemotherapy. These treatments have shown improved outcomes in extensive-stage SCLC. While Ifinatamab Deruxtecan, an antibody-drug conjugate (ADC), is still under investigation, similar ADCs like fam-trastuzumab deruxtecan have shown promise in other cancers, suggesting potential for future SCLC treatments. Current investigational approaches also include novel immunotherapy agents and targeted therapies.

What other types of research exist?

Promising novel alternatives to Ifinatamab Deruxtecan for Small Cell Lung Cancer patients include: 1) Sacituzumab Govitecan, an ADC targeting Trop-2, which has shown efficacy in various cancers including urothelial carcinoma. 2) Trastuzumab Deruxtecan, an ADC targeting HER2, which has demonstrated antitumor activity in preclinical models and clinical trials. 3) Durvalumab, an anti-PD-L1 antibody, which has shown improved outcomes in combination with chemotherapy for high tumor mutational burden NSCLC and may have potential in SCLC.

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Antibody-Drug Conjugate

I-DXd for Small Cell Lung Cancer (IDeate-Lung01 Trial)

Phase 2

Waitlist Available

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

Must not have

Female who is pregnant or breast-feeding or intends to become pregnant during the study

Clinically significant corneal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, ifinatamab deruxtecan (I-DXd), on patients with a specific type of lung cancer who have not responded to other treatments. The drug aims to target and kill cancer cells.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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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.

Exclusion Criteria

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

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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

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I have a serious eye condition affecting my cornea.

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I have or had lung inflammation not caused by infection, treated with steroids.

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I have brain metastases or spinal issues that are untreated or causing symptoms.

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I have not been treated with orlotamab, enoblituzumab, or similar drugs.

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I have severe lung problems due to other lung diseases.

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I do not have any uncontrolled infections including HIV.

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I do not have active or uncontrolled hepatitis B or C.

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I have serious heart problems that are not under control.

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I have an autoimmune disease.

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I have had a transplant of bone marrow, stem cells, or an organ.

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I have side effects from cancer treatment that haven't improved to mild or gone back to how they were before treatment.

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I have been treated with a specific type of cancer drug linked to a toxin (like trastuzumab deruxtecan).

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 36 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Therapeutic procedure

Secondary study objectives

Therapeutic procedure

Disease Control Rate (DCR) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC

Therapeutic procedure

+10 more

Awards & Highlights

No Placebo-Only Group

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

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.

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy, immunotherapy, and antibody-drug conjugates (ADCs). Chemotherapy drugs like etoposide and cisplatin work by damaging the DNA of rapidly dividing cancer cells, leading to their death. Immunotherapy, such as PD-1 or PD-L1 inhibitors, boosts the immune system's ability to recognize and destroy cancer cells. ADCs, like Ifinatamab Deruxtecan, combine a monoclonal antibody that targets cancer cells with a cytotoxic drug, allowing for precise delivery of the drug to cancer cells while minimizing harm to normal cells. This targeted approach is crucial for SCLC patients due to the aggressive nature of the disease and the need for effective treatments with fewer side effects.