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Checkpoint Inhibitor

I-DXd + Atezolizumab for Small Cell Lung Cancer

Phase 1 & 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

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

For Cohort 1 Part A, 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

Must not have

Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses

Has received prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents, including I-DXd

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test if a new drug called ifinatamab deruxtecan, when combined with another drug atezolizumab, is safe and effective in treating small cell

Who is the study for?

Adults diagnosed with extensive stage-small cell lung cancer (ES-SCLC) needing first-line therapy can join. They must have good physical function and adequate organ function, agree to contraception use, and provide consent for biopsies if required. Women must test negative for pregnancy.

What is being tested?

The trial is testing the combination of I-DXd with atezolizumab, plus or minus carboplatin, in new ES-SCLC patients. It aims to assess safety and effectiveness as both initial treatment and ongoing maintenance therapy.

What are the potential side effects?

Potential side effects may include immune-related reactions due to atezolizumab, blood count changes from carboplatin, nausea from etoposide, and infusion-related symptoms from I-DXd.

Eligibility Criteria

Inclusion Criteria

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

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My small cell lung cancer diagnosis is confirmed and I need first-line therapy.

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I've had 4 rounds of specific chemo and immunotherapy for small-cell lung cancer and my cancer is stable or shrinking.

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I have not received any treatment for small cell lung cancer.

Exclusion Criteria

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

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I have severe lung problems due to other lung diseases.

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I have been treated with drugs targeting B7-H3, like orlotamab or enoblituzumab.

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I have a serious eye condition affecting my cornea.

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I have serious heart problems that are not under control.

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I have or had lung inflammation that needed steroids, or it might be present but not confirmed by scans.

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I am on a daily steroid treatment of 10 mg or more, not counting inhalers, skin creams, or joint injections.

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

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I have an active and uncontrolled infection.

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I have HIV that is not well controlled.

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I stopped taking a specific cancer drug due to side effects.

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I have had a stroke, mini-stroke, or blood clot in an artery in the last 6 months.

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I have active brain metastases or spinal issues needing steroids or anticonvulsants.

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I have an active or uncontrolled hepatitis B or C infection.

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I still have side effects from cancer treatment that haven't improved.

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I have a severe illness that is not under control.

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I am pregnant, breastfeeding, or planning to become pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Best Percentage Change in the Sum of Diameters (SoD) of Measurable Tumors 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)

Clinical Benefit 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 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)

+9 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

7Treatment groups

Experimental Treatment

Group I: Cohort 2, Part B: Induction + Maintenance (I-DXd 8 mg/kg)Experimental Treatment3 Interventions

Participants who are treatment-naive, newly diagnosed with ES-SCLC will receive 4 cycles of 1L I-DXd induction therapy (8 mg/kg IV Q3W) + atezolizumab (1200 mg IV Q3W) + carboplatin (AUC 5 mg/ml×min IV Q3W) followed by maintenance therapy (I-DXd 8 mg/kg IV Q3W) + atezolizumab (1200 mg IV Q3W).

Group II: Cohort 2, Part B: Induction + Maintenance (I-DXd 12 mg/kg)Experimental Treatment3 Interventions

Participants who are treatment-naive, newly diagnosed with ES-SCLC will receive 4 cycles of IL I-DXd induction therapy (12 mg/kg IV Q3W) + atezolizumab (1200 mg IV Q3W) + carboplatin (AUC 5 mg/ml×minIV Q3W) followed by maintenance therapy (I-DXd 12 mg/kg IV Q3W) + atezolizumab (1200 mg IV Q3W).

Group III: Cohort 2, Part A: Induction + Maintenance (I-DXd 8 mg/kg)Experimental Treatment3 Interventions

Part A (Safety Run-in): Participants who are treatment-naive, newly diagnosed with ES-SCLC will receive 4 cycles of 1L I-DXd induction therapy (8 mg/kg IV Q3W) + atezolizumab (1200 mg IV Q3W) + carboplatin (AUC 5 mg/ml×min IV Q3W) followed by maintenance therapy (I-DXd 8 mg/kg IV Q3W) + atezolizumab (1200 mg IV Q3W).

Group IV: Cohort 2, Part A: Induction + Maintenance (I-DXd 12 mg/kg)Experimental Treatment3 Interventions

Part A (Safety Run-in): Participants who are treatment-naive, newly diagnosed with ES-SCLC will receive 4 cycles of IL I-DXd induction therapy (12 mg/kg IV Q3W) + atezolizumab (1200 mg IV Q3W) + carboplatin (AUC 5 mg/ml×min IV Q3W) followed by maintenance therapy (I-DXd 12 mg/kg IV Q3W) + atezolizumab (1200 mg IV Q3W).

Group V: Cohort 1, Part B: Maintenance (I-DXd 8 mg/kg)Experimental Treatment2 Interventions

Part B: Participants who must have received 4 cycles of 1L induction standard of care (SoC) therapy with best overall response of CR, PR, or SD will receive maintenance therapy only (I-DXd 8 mg/kg IV Q3W + atezolizumab 1200 mg IV Q3W), starting at Cycle 1 Day 1.

Group VI: Cohort 1, Part B: Maintenance (I-DXd 12 mg/kg)Experimental Treatment2 Interventions

Part B: Participants who must have received 4 cycles of 1L induction standard of care (SoC) therapy with best overall response of CR, PR, or SD will receive maintenance therapy only (I-DXd 12 mg/kg IV Q3W + atezolizumab 1200 mg IV Q3W), starting at Cycle 1 Day 1.

Group VII: Cohort 1, Part A: Maintenance Only (I-DXd 12 mg/kg)Experimental Treatment2 Interventions

Part A (Safety Run-in): Participants who must have received 4 cycles of 1L induction standard of care (SoC) therapy with best overall response of CR, PR, or SD will receive maintenance therapy only (I-DXd 12 mg/kg IV Q3W + atezolizumab 1200 mg IV Q3W). A 5-day surveillance period between each of the first 3 participants (up to a maximum of 9 participants) dosed is included as a safety measure.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

Carboplatin

2014

Completed Phase 3

~6120