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AzTrials

Extensive Stage-small Cell Lung CancerPhase 1/2NCT06362252

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)

A Phase 1/2 study testing Ifinatamab deruxtecan, Atezolizumab and Carboplatin in people with Extensive Stage-small Cell Lung Cancer, run by Daiichi Sankyo at 58 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Extensive Stage-small Cell Lung Cancer
What is being tested?
Ifinatamab deruxtecan, Atezolizumab and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
123 participants
Where
58 sitesin 4 countries
Study dates
22 Jul 2024to 20 Feb 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must meet all of the following criteria to be eligible for enrollment into the study:
  • 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.
  • For Cohort 2, participant has received no prior treatment for ES-SCLC.
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  • For Cohort 2, participant has at least one measurable lesion according to RECIST v1.1 on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by the investigator.
  • For Cohort 2, participant must have at least one lesion, amenable to core biopsy, and must consent to provide a pretreatment biopsy tissue sample and on-treatment biopsy.
  • Has ECOG PS of ≤1 (assessed within 7 days before enrollment/randomization).
  • Has adequate organ and bone marrow function within 7 days before the start of study treatment as specified in the study protocol.
  • A female subject of childbearing potential (POCBP) is eligible to participate if the following conditions are met:
  • Subject is not pregnant as confirmed by highly sensitive pregnancy test during Screening (within 3 days prior to enrollment/randomization)
  • Subject does not breastfeed during the treatment period and for at least 8/5/6 months after last dose of I-DXd/atezolizumab/carboplatin, respectively.
  • Subject agrees to adhere to a contraceptive method that is highly effective and agrees not to donate eggs (ova, oocytes) to others or freeze/store eggs during the treatment period and for at least the time needed to eliminate each study drug after the last dose. The length of time required to continue contraception and avoid donating/freezing eggs after last dose for I-DXd/atezolizumab/carboplatin is 8/5/6 months, respectively. Preservation of eggs may be considered prior to first dose of study drug.
  • A male subject capable of producing sperm is eligible to participate if he agrees to the following during the intervention period and for at least the time needed to eliminate each study drug. The length of time required to continue contraception and avoid donating sperm after last dose for I-DXd/atezolizumab/carboplatin is 6/5/6 months, respectively.
  • Avoid donating sperm.
  • Adhere to either of the contraception methods: true abstinence from penile-vaginal intercourse or uses a penile/external condom when having penile-vaginal intercourse with a non-subject of childbearing potential plus partner use of an additional contraceptive method.
  • Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.

Who cannot join

  • Participants who meet any of the following criteria will be disqualified from entering the study:
  • Has received prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents, including I-DXd.
  • Prior discontinuation of an ADC that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities.
  • Has received prior treatment with CD137 agonists or ICIs, including anti-cytotoxic T-cell lymphocyte-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, except for atezolizumab for Cohort 1.
  • Has inadequate washout period before enrollment/randomization as specified in the study protocol.
  • Has any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event.
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  • Has clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.
  • Has clinically significant corneal disease.
  • Has uncontrolled or significant cardiovascular disease,.
  • Has history of (non-infectious) ILD/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at Screening.
  • Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
  • Is on chronic steroid treatment (dose of 10 mg daily or more prednisone equivalent), except for low-dose inhaled steroids (for asthma/chronic obstructive pulmonary disease, topical steroids (for mild skin conditions), or intra-articular steroid injections.
  • Has history of malignancy other than SCLC within the 5 years prior to randomization/enrollment, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, superficial gastrointestinal tract tumors, and non-muscle invasive bladder cancer curatively resected by endoscopic surgery.
  • Has history of allogeneic bone marrow, stem cell, or solid organ transplant.
  • Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE V5.0, Grade ≤1 or baseline.
  • Has history of hypersensitivity to the drug substances, inactive ingredients in the drug product or severe hypersensitivity reactions to other monoclonal antibodies.
  • Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
  • Has active or uncontrolled human immunodeficiency virus (HIV) infection.
  • Has active or uncontrolled hepatitis B or C virus (HBV or HCV) infection.
  • Has history of autoimmune disease.
  • Has any evidence of severe or uncontrolled systemic diseases.
  • Has received a live vaccine within 30 days prior to the first dose of study drug.
  • Is a female who is pregnant or breastfeeding or planning to become pregnant.
  • Has prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the participant; alter the absorption, distribution, metabolism, or excretion of the study drug; or confound the assessment of study results.
  • Has psychological, social, familial, or logistical factors that would prevent regular follow-up

Trial locations and contacts

58 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

(US) Daiichi Sankyo Contact for Clinical Trial Information contact

9089926400

CTRinfo_us@daiichisankyo.com

(Asia) Daiichi Sankyo Contact for Clinical Trial Information contact

+81-3-6225-1111 (M-F 9-5 JST

dsclinicaltrial_jp@daiichisankyo.com

58 sites in 4 countries

United States26 sites, 25 recruiting

  • University of Alabama -Birmingham

    Birmingham, Alabama, 35233

    Principal Investigator

    Recruiting

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    Chicago, Illinois, 60611

    Principal Investigator

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Active, not recruiting

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

    Recruiting

  • Next Virginia

    Fairfax, Virginia, 22031

    Principal Investigator

    Recruiting

  • John Theurer Cancer Center At Hackensack Umc

    Hackensack, New Jersey, 07601

    Principal Investigator

    Recruiting

  • Mayo Clinic-Jacksonville

    Jacksonville, Florida, 32224

    Principal Investigator

    Recruiting

  • Lancaster General Hospital - Ann B Barshinger Cancer Institute

    Lancaster, Pennsylvania, 17601

    Recruiting

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

    Principal Investigator

    Recruiting

  • David Geffen School of Medicine

    Los Angeles, California, 90095

    Principal Investigator

    Not yet recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Principal Investigator

    Recruiting

  • New York University Cancer Center - Laura and Isaac Perlmutter Cancer Center At Nyu Langone

    Mineola, New York, 11501

    Principal Investigator

    Recruiting

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501

    Principal Investigator

    Recruiting

  • Regents of the University of Minnesota

    Minneapolis, Minnesota, 55455

    Principal Investigator

    Recruiting

  • Scri Oncology Partners

    Nashville, Tennessee, 37203

    Principal Investigator

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

    Principal Investigator

    Recruiting

  • Columbia University Hervert Irving Comprehensive Cancer Center

    New York, New York, 10032

    Principal Investigator

    Recruiting

  • Montefiore Medical Center

    New York, New York, 10461

    Recruiting

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

    Principal Investigator

    Recruiting

  • Advent Health Orlando

    Orlando, Florida, 32804

    Principal Investigator

    Recruiting

  • University of Pennsylvania, Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Thomas Jefferson University Hospital - Central

    Philadelphia, Pennsylvania, 19107

    Principal Investigator

    Recruiting

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

    Principal Investigator

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Principal Investigator

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Recruiting

  • Northwest Cancer Specialists, P.C.-Vancouver

    Vancouver, Washington, 98684

    Principal Investigator

    Recruiting

Other trials in United States

Spain12 sites, 12 recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036

    Principal Investigator

    Recruiting

  • Hospital Universitari Vall D'Hebron

    Barcelona, 8035

    Principal Investigator

    Recruiting

  • Ico Girona - Hospital Universitari de Girona Dr Josep Trueta

    Girona, 17007

    Principal Investigator

    Recruiting

  • ICO l'Hospitalet - Hospital Duran i Reynals

    L'Hospitalet de Llobregat, 08908

    Principal Investigator

    Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

    Principal Investigator

    Recruiting

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

    Principal Investigator

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Principal Investigator

    Recruiting

  • Next Madrid

    Madrid, 28223

    Principal Investigator

    Recruiting

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

    Principal Investigator

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    Principal Investigator

    Recruiting

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

    Principal Investigator

    Recruiting

  • Hospital Alvaro Cunqueiro

    Vigo, 36312

    Principal Investigator

    Recruiting

Other trials in Spain

Japan11 sites, 11 recruiting

  • NHO Himeji Medical Center

    Himeji-shi, 670-8520

    Recruiting

  • Kansai Medical University Hospital

    Hirakata-shi, 573-1191

    Principal Investigator

    Recruiting

  • National Cancer Center Hospital East

    Kashiwa, 277-8577

    Principal Investigator

    Recruiting

  • The Cancer Institute Hospital of Jfcr

    Kōtoku, 135-8550

    Principal Investigator

    Recruiting

  • Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital

    Kumamoto, 861-4193

    Principal Investigator

    Recruiting

  • Shizuoka Cancer Center

    Nagaizumi-cho, 411-8777

    Principal Investigator

    Recruiting

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

    Principal Investigator

    Recruiting

  • Okayama University Hospital

    Okayama, 700-8558

    Principal Investigator

    Recruiting

  • Kindai University Hospital

    Ōsaka-sayama, 589-8511

    Principal Investigator

    Recruiting

  • Tokushima University Hospital

    Tokushima, 770-8503

    Recruiting

  • Fujita Health University Hospital

    Toyoake-shi, 470-1192

    Recruiting

Other trials in Japan

France9 sites, 9 recruiting

  • Hopital Albert Calmette - Chu Lille

    Lille, 59037

    Principal Investigator

    Recruiting

  • Centre Léon Bérard

    Lyon, 69008

    Principal Investigator

    Recruiting

  • Hôpital de la Timone

    Marseille, 13005

    Principal Investigator

    Recruiting

  • Institut Curie - Site de Paris

    Paris, 75005

    Principal Investigator

    Recruiting

  • Hopital Tenon

    Paris, 75020

    Principal Investigator

    Recruiting

  • Chu Rennes - Hopital Pontchaillou

    Rennes, 35000

    Principal Investigator

    Recruiting

  • CHU Nantes - Hôpital Guillaume et René Laënnec

    Saint-Herblain, 44805

    Principal Investigator

    Recruiting

  • Hôpital Foch

    Suresnes, 92151

    Principal Investigator

    Recruiting

  • Institut Gustave Roussy

    Villejuif, 94805

    Principal Investigator

    Not yet recruiting

Other trials in France

About this study

Official title: A Phase 1b/2, Multicenter, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody-Drug Conjugate (ADC), in Combination With Atezolizumab With or Without Carboplatin as First-line Induction or Maintenance, in Subjects With Extensive-stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung03)

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.

Read the detailed description

This study consists of two parts and two cohorts: Part A (Phase 1b; Safety Run-in) and Part B (Phase 2; Dose Optimization), Cohort 1 (I-DXd in maintenance) and Cohort 2 (I-DXd in induction + maintenance).

The primary objective of this study is to evaluate the safety and tolerability of I-DXd in combination with atezolizumab with or without carboplatin by assessing treatment-emergent adverse events (TEAEs) and other safety parameters which will inform optimal dose selection of I-DXd in the combination regimens (Dose Optimization Part B) of this study.

Being tested
Ifinatamab deruxtecan, Atezolizumab, Carboplatin
Keywords
Extensive stage-small cell lung cancer (ES-SCLC), Ifinatamab deruxtecan, I-DXd

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ifinatamab deruxtecanDrug

    Also called I-DXd

    Intravenous administration

  • AtezolizumabDrug

    Intravenous administration

  • CarboplatinDrug

    Intravenous administration

Study groups in NCT06362252
Study groupRoleWhat they receive
Cohort 1, Part A: Maintenance Only (I-DXd 12 mg/kg)ExperimentalPart 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. Maintenance therapy consisting of I-DXd 12 mg/kg (or a lower dose based on data for I-DXd collected during the study) + 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.
Receives: Drug: Ifinatamab deruxtecan; Drug: Atezolizumab
Cohort 2, Part A: Induction + Maintenance (I-DXd 8 mg/kg)ExperimentalPart 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. Maintenance therapy consisting of I-DXd 8 mg/kg (or a lower dose based on data for I-DXd collected during the study) + atezolizumab 1200 mg IV Q3W.
Receives: Drug: Ifinatamab deruxtecan; Drug: Atezolizumab; Drug: Carboplatin
Cohort 2, Part A: Induction + Maintenance (I-DXd 12 mg/kg)ExperimentalPart A (Safety Run-in): Participants who are treatment-naive, newly diagnosed with ES-SCLC will receive 4 cycles of 1L 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. Maintenance therapy consisting of I-DXd 12 mg/kg (or a lower dose based on data for I-DXd collected during the study) + atezolizumab 1200 mg IV Q3W.
Receives: Drug: Ifinatamab deruxtecan; Drug: Atezolizumab; Drug: Carboplatin
Cohort 1, Part B: Maintenance (I-DXd 8 mg/kg)ExperimentalPart 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 starting at Cycle 1 Day 1. Maintenance therapy consisting of I-DXd 8 mg/kg (or a lower dose based on data for I-DXd collected during the study) + atezolizumab 1200 mg IV Q3W
Receives: Drug: Ifinatamab deruxtecan; Drug: Atezolizumab
Cohort 1, Part B: Maintenance (I-DXd 12 mg/kg)ExperimentalPart 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 starting at Cycle 1 Day 1. Maintenance therapy consisting of I-DXd 12 mg/kg (or a lower dose based on data for I-DXd collected during the study) + atezolizumab 1200 mg IV Q3W.
Receives: Drug: Ifinatamab deruxtecan; Drug: Atezolizumab
Cohort 2, Part B: Induction + Maintenance (I-DXd 8 mg/kg)ExperimentalParticipants 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. Maintenance therapy consisting of I-DXd 8 mg/kg (or a lower dose based on data for I-DXd collected during the study) + atezolizumab 1200 mg IV Q3W.
Receives: Drug: Ifinatamab deruxtecan; Drug: Atezolizumab; Drug: Carboplatin
Cohort 2, Part B: Induction + Maintenance (I-DXd 12 mg/kg)ExperimentalParticipants 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. Maintenance therapy consisting of I-DXd 12 mg/kg (or a lower dose based on data for I-DXd collected during the study) + atezolizumab 1200 mg IV Q3W.
Receives: Drug: Ifinatamab deruxtecan; Drug: Atezolizumab; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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)

    Measured: Baseline up to 37 months

Secondary outcomes (12)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

  5. 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)

    Clinical benefit rate (CBR) is defined as the proportion of participants who achieved a best overall response of confirmed CR, confirmed PR, or SD lasting for at least 180 days.

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

  6. Time to 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)

    Time to response (TTR) is defined as the time from the date of enrollment/randomization to the date of the first documentation of objective response (confirmed CR or confirmed PR) in responding subjects.

    Measured: From the start date of study drug to the date of the first documentation of response (CR or PR) that is subsequently confirmed, up to approximately 37 months

  7. 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)

    The best percentage change in SoD is defined as the percentage change in the smallest SoD from all post-baseline tumor assessments, taking as reference the baseline SoD.

    Measured: Baseline up to approximately 37 months

  8. Overall Survival Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B)

    Time from the date of enrollment/randomization to the date of death due to any cause.

    Measured: From the start date of study drug to the date of death due to any cause, whichever occurs first, up to approximately 37 months

  9. Pharmacokinetic Parameter Maximum Serum Concentration of I-DXd

    Maximum serum concentration (Cmax) will be assessed using non-compartmental methods.

    Measured: Cycle 1 Day 1 pre-dose up to Cycle 9 (and every 2 cycles thereafter up to 37 months) Day 1 pre-dose (each cycle is 21 days)

  10. Pharmacokinetic Parameter Time to Maximum Serum Concentration of I-DXd

    Time to maximum serum concentration (Tmax) will be assessed using non-compartmental methods.

    Measured: Cycle 1 Day 1 pre-dose up to Cycle 9 (and every 2 cycles thereafter up to 37 months) Day 1 pre-dose (each cycle is 21 days)

  11. Pharmacokinetic Parameter Area Under the Concentration Curve of I-DXd

    Area under the concentration-time curve up to the last quantifiable time (AUClast) and Area under the concentration-time curve during dosing interval (AUCtau) will be assessed using non-compartmental methods.

    Measured: Cycle 1 Day 1 pre-dose up to Cycle 9 (and every 2 cycles thereafter up to 37 months) Day 1 pre-dose (each cycle is 21 days)

  12. The Number of Participants Who Are Anti-Drug Antibody (ADA)-Positive At Any Time and Who Have A Treatment-emergent Anti-Drug Antibody

    The ADA prevalence, which is the percentage of participants who are ADA positive at any time point (baseline or postbaseline), as well as the ADA incidence, which is the proportion of participants having treatment-emergent ADA during the study period, will be reported.

    Measured: Baseline up to approximately 37 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2024
  2. Study start22 Jul 2024
  3. Primary completion20 Jul 2027 (estimated)
  4. Study completion20 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
123 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06362252
Sponsor's protocol ID
DS7300-189
Other IDs
2023-509629-36, 2031240089, 2023
Status last verified
Sep 2026
First submitted
2 Jan 2024
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ifinatamab deruxtecan, Atezolizumab and Carboplatin in people with Extensive Stage-small Cell Lung Cancer, run by Daiichi Sankyo at 58 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, Spain, Japan, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact (US) Daiichi Sankyo Contact for Clinical Trial Information (9089926400, CTRinfo_us@daiichisankyo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06362252.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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