A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice (TPC) in Subjects With Relapsed Small Cell Lung Cancer (SCLC) (IDeate-Lung02)
Summary
This study was designed to compare the efficacy and safety of I-DXd with treatment of physician's choice in participants with relapsed small cell lung cancer (SCLC).
Detailed description
The primary objective of this study is to assess whether treatment with I-DXd improves objective response rate (ORR) and prolongs overall survival (OS) compared with treatment of physician's choice among participants with relapsed SCLC. The secondary objectives of the study are to further evaluate the efficacy/safety of I-DXd, health economics and outcome research measures (including patient reported outcomes), immunogenicity of I-DXd, B7-H3 protein expression, and characterize the pharmacokinetics of I-DXd.
Arms & interventions
- DrugIfinatamab deruxtecan
12 mg/kg intravenous dose on Day 1 of each 21-day cycle
- DrugTopotecan
Topotecan will be administered per local SoC.
- DrugAmrubicin
Amrubicin will be administered per local SoC.
- DrugLurbinectedin
Lurbinectedin will be administered per local SoC
Outcome measures
Primary
Number of Participants With Objective Response Rate Assessed by Blinded Independent Central Review
Confirmed objective response rate (ORR) is defined as the sum of the complete response (CR) rate and partial response (PR) rate based on BICR by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Time frame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
Overall Survival
Time frame: From the date of randomization to the date of death due to any cause, up to approximately 5 years
Secondary
Number of Participants With Objective Response Rate Assessed by Investigator
Time frame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
Progression-free Survival As Assessed by Blinded Independent Central Review and Investigator
Time frame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
Duration of Response As Assessed by Blinded Independent Central Review and Investigator
Time frame: 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 5 years
Disease Control Rate As Assessed by Blinded Independent Central Review and Investigator
Time frame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
Time to Response As Assessed by Blinded Independent Central Review and Investigator
Time frame: 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 5 years
Change from Baseline in The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30
Time frame: Baseline up to 5 years
Change from Baseline in The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 29 (EORTC QLQ-LC29)
Time frame: Baseline up to 5 years
Overall Number of Participants With Treatment-emergent Adverse Events Following I-DXd Monotherapy
Time frame: Baseline up to 5 years
The Number of Participants Who Are Anti-Drug Antibody (ADA)-Positive At Any Time and Who Have A Treatment-emergent Anti-Drug Antibody
Time frame: Baseline up to 5 years
Pharmacokinetic Parameter Maximum Concentration for I-DXd, Total Anti-B7-H3 Antibody, and MAAA-1181a
Time frame: Cycle 1 before infusion (BI), end of infusion EOI), and 3, 6, 24, 72, 168, 336, and 504 hours (hrs) post dose; Cycle 2 BI and EOI; Cycle 3 BI, EOI, and 6 hrs postdose; Cycles 4, 5, and every 2 cycles thereafter up to 5 years BI (each cycle is 21 days)
Pharmacokinetic Parameter Time to Maximum Concentration for I-DXd, Total Anti-B7-H3 Antibody, and MAAA-1181a
Time frame: Cycle 1 before infusion (BI), end of infusion EOI), and 3, 6, 24, 72, 168, 336, and 504 hours (hrs) post dose; Cycle 2 BI and EOI; Cycle 3 BI, EOI, and 6 hrs postdose; Cycles 4, 5, and every 2 cycles thereafter up to 5 years BI (each cycle is 21 days)
Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve for I-DXd, Total Anti-B7-H3 Antibody, and MAAA-1181a
Time frame: Cycle 1 before infusion (BI), end of infusion EOI), and 3, 6, 24, 72, 168, 336, and 504 hours (hrs) post dose; Cycle 2 BI and EOI; Cycle 3 BI, EOI, and 6 hrs postdose; Cycles 4, 5, and every 2 cycles thereafter up to 5 years BI (each cycle is 21 days)
Eligibility criteria
Study locations (30)
Highlands Oncology Group
Springdale, Arkansas, 72762
Clinical Research Providence Medical Foundation
Fullerton, California, 92835
UCLA Hematology-Oncology
Los Angeles, California, 90095
UCSF Mission Bay Mission Hall
San Francisco, California, 94115
University of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
AdventHealth Orlando, Cancer Institute
Orlando, Florida, 32804
H. Lee Moffitt Cancer Center and Research Institute, Inc
Tampa, Florida, 33612
Rush MD Anderson Cancer Center
Chicago, Illinois, 60612
Baptist Health Lexington
Lexington, Kentucky, 40503
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
John Hopkins School of Medicine
Baltimore, Maryland, 21287
Dana-Farber Cancer Institute
Boston, Massachusetts, 02216
Henry Ford Health System
Detroit, Michigan, 48202
Mercy Clinic Oncology and Hematology Sindelar Cancer Center
St Louis, Missouri, 63128
University of Nebraska Medical Center
Omaha, Nebraska, 68198-6811
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
Astera Cancer Care
East Brunswick, New Jersey, 08816
Hackensack Meridian Health Jsumc
Neptune City, New Jersey, 07753
Clinical Research Alliance, Inc
Lake Success, New York, 11042
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health Long Island
New York, New York, 10016
New York University Cancer Center - Laura and Isaac
New York, New York, 10016
Montefiore Medical Center Prime
The Bronx, New York, 10461
Cleveland Clinic Mercy Hospital
Canton, Ohio, 44708
Oncology/Hematology Care Clinical Trials, Llc
Cincinnati, Ohio, 45236
Providence Portland Medical Center
Portland, Oregon, 97213
THE WEST CLINIC, PLLC dba West Cancer Center
Germantown, Tennessee, 38138
Houston Methodist Cancer Center
Houston, Texas, 77030
University of Texas Md Anderson Cancer Center
Houston, Texas, 77030
Texas Oncology, P.A. - Tyler
Tyler, Texas, 75702
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
References
- Owonikoko TK, Byers L, Cheng Y, Hayashi H, Paz-Ares L, Perol M, Hu H, Qian M, Garcia CR, Godard J, Tang M, Rudin CM. IDeate-Lung02: a Phase 3 study of second-line ifinatamab deruxtecan in patients with relapsed small cell lung cancer. Future Oncol. 2025 Oct;21(25):3275-3282. doi: 10.1080/14796694.2025.2565995. Epub 2025 Oct 7.(PubMed)