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)

NCT06362252 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: DS7300-1892023-509629-362031240089
• Study Type: interventional
• Target: 123
• Locations: 4 countries
• Sites: 58

Brief 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.

Conditions

Extensive Stage-small Cell Lung Cancer

Keywords

Extensive stage-small cell lung cancer (ES-SCLC); Ifinatamab deruxtecan; I-DXd

Outcome Measures

Primary Outcomes (2)

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

  Cycle 1 Day 1 up to Cycle 1 Day 21 (each cycle is 21 days)

• Overall Number of Participants With Treatment-emergent Adverse Events Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B)

  Baseline up to 37 months

Secondary Outcomes (12)

• 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)

  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

• 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)

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

• 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)

  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

• 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)

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

• 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)

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

Study Arms (7)

Cohort 1, Part A: Maintenance Only (I-DXd 12 mg/kg)

EXPERIMENTAL

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. 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.

Drug: Ifinatamab deruxtecan; Drug: Atezolizumab

Cohort 2, Part A: Induction + Maintenance (I-DXd 8 mg/kg)

EXPERIMENTAL

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. 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.

Drug: Ifinatamab deruxtecan; Drug: Atezolizumab; Drug: Carboplatin

Cohort 2, Part A: Induction + Maintenance (I-DXd 12 mg/kg)

EXPERIMENTAL

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 (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.

Drug: Ifinatamab deruxtecan; Drug: Atezolizumab; Drug: Carboplatin

Cohort 1, Part B: Maintenance (I-DXd 8 mg/kg)

EXPERIMENTAL

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 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

Drug: Ifinatamab deruxtecan; Drug: Atezolizumab

Cohort 1, Part B: Maintenance (I-DXd 12 mg/kg)

EXPERIMENTAL

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 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.

Drug: Ifinatamab deruxtecan; Drug: Atezolizumab

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

EXPERIMENTAL

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.

Drug: Ifinatamab deruxtecan; Drug: Atezolizumab; Drug: Carboplatin

Cohort 2, Part B: Induction + Maintenance (I-DXd 12 mg/kg)

EXPERIMENTAL

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. 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.

Drug: Ifinatamab deruxtecan; Drug: Atezolizumab; Drug: Carboplatin

Interventions

Ifinatamab deruxtecan DRUG

Intravenous administration

Also known as: I-DXd

Cohort 1, Part A: Maintenance Only (I-DXd 12 mg/kg); Cohort 1, Part B: Maintenance (I-DXd 12 mg/kg); Cohort 1, Part B: Maintenance (I-DXd 8 mg/kg); Cohort 2, Part A: Induction + Maintenance (I-DXd 12 mg/kg); Cohort 2, Part A: Induction + Maintenance (I-DXd 8 mg/kg); Cohort 2, Part B: Induction + Maintenance (I-DXd 12 mg/kg); Cohort 2, Part B: Induction + Maintenance (I-DXd 8 mg/kg)

Atezolizumab DRUG

Intravenous administration

Cohort 1, Part A: Maintenance Only (I-DXd 12 mg/kg); Cohort 1, Part B: Maintenance (I-DXd 12 mg/kg); Cohort 1, Part B: Maintenance (I-DXd 8 mg/kg); Cohort 2, Part A: Induction + Maintenance (I-DXd 12 mg/kg); Cohort 2, Part A: Induction + Maintenance (I-DXd 8 mg/kg); Cohort 2, Part B: Induction + Maintenance (I-DXd 12 mg/kg); Cohort 2, Part B: Induction + Maintenance (I-DXd 8 mg/kg)

Carboplatin DRUG

Intravenous administration

Cohort 2, Part A: Induction + Maintenance (I-DXd 12 mg/kg); Cohort 2, Part A: Induction + Maintenance (I-DXd 8 mg/kg); Cohort 2, Part B: Induction + Maintenance (I-DXd 12 mg/kg); Cohort 2, Part B: Induction + Maintenance (I-DXd 8 mg/kg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Daiichi Sankyo: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (58)

University of Alabama -Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

RECRUITING

David Geffen School of Medicine

Los Angeles, California, 90095, United States

NOT YET RECRUITING

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

RECRUITING

Mayo Clinic-Jacksonville

Jacksonville, Florida, 32224, United States

RECRUITING

Advent Health Orlando

Orlando, Florida, 32804, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

ACTIVE NOT RECRUITING

Regents of the University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

RECRUITING

Astera Cancer Care

East Brunswick, New Jersey, 08816, United States

RECRUITING

John Theurer Cancer Center At Hackensack Umc

Hackensack, New Jersey, 07601, United States

RECRUITING

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

Mineola, New York, 11501, United States

RECRUITING

NYU Langone Hospital - Long Island

Mineola, New York, 11501, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

RECRUITING

Columbia University Hervert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

RECRUITING

Montefiore Medical Center

New York, New York, 10461, United States

RECRUITING

Lancaster General Hospital - Ann B Barshinger Cancer Institute

Lancaster, Pennsylvania, 17601, United States

RECRUITING

University of Pennsylvania, Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Thomas Jefferson University Hospital - Central

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Scri Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

Next Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

Northwest Cancer Specialists, P.C.-Vancouver

Vancouver, Washington, 98684, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Hopital Albert Calmette - Chu Lille

Lille, 59037, France

RECRUITING

Centre Léon Bérard

Lyon, 69008, France

RECRUITING

Hôpital de la Timone

Marseille, 13005, France

RECRUITING

Institut Curie - Site de Paris

Paris, 75005, France

RECRUITING

Hopital Tenon

Paris, 75020, France

RECRUITING

Chu Rennes - Hopital Pontchaillou

Rennes, 35000, France

RECRUITING

CHU Nantes - Hôpital Guillaume et René Laënnec

Saint-Herblain, 44805, France

RECRUITING

Hôpital Foch

Suresnes, 92151, France

RECRUITING

Institut Gustave Roussy

Villejuif, 94805, France

NOT YET RECRUITING

NHO Himeji Medical Center

Himeji-shi, 670-8520, Japan

RECRUITING

Kansai Medical University Hospital

Hirakata-shi, 573-1191, Japan

RECRUITING

National Cancer Center Hospital East

Kashiwa, 277-8577, Japan

RECRUITING

The Cancer Institute Hospital of Jfcr

Kōtoku, 135-8550, Japan

RECRUITING

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

Kumamoto, 861-4193, Japan

RECRUITING

Shizuoka Cancer Center

Nagaizumi-cho, 411-8777, Japan

RECRUITING

Niigata Cancer Center Hospital

Niigata, 951-8566, Japan

RECRUITING

Okayama University Hospital

Okayama, 700-8558, Japan

RECRUITING

Kindai University Hospital

Ōsaka-sayama, 589-8511, Japan

RECRUITING

Tokushima University Hospital

Tokushima, 770-8503, Japan

RECRUITING

Fujita Health University Hospital

Toyoake-shi, 470-1192, Japan

RECRUITING

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Hospital Universitari Vall D'Hebron

Barcelona, 8035, Spain

RECRUITING

Ico Girona - Hospital Universitari de Girona Dr Josep Trueta

Girona, 17007, Spain

RECRUITING

ICO l'Hospitalet - Hospital Duran i Reynals

L'Hospitalet de Llobregat, 08908, Spain

RECRUITING

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

RECRUITING

Hospital Universitario Ramon Y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Next Madrid

Madrid, 28223, Spain

RECRUITING

Hospital Regional Universitario de Malaga

Málaga, 29010, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

RECRUITING

Hospital Alvaro Cunqueiro

Vigo, 36312, Spain

RECRUITING

MeSH Terms

Interventions

atezolizumab; Carboplatin

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Central Study Contacts

(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@daiichisankyo.co.jp

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: April 12, 2024
• Study Start: July 22, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

US (26); JP (11); ES (12); FR (9)