RecruitingPhase 3

A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

This study is 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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria Participants must meet all the following criteria to be eligible for randomization into the study: 1. Sign and date the informed consent form (ICF) prior to the start of any study-specific qualification procedures. 2. Adults greater than or equal to (≥)18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed. 3. Has histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC). 4. The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content. 5. Has received prior therapy with only one prior platinum-based line as systemic therapy for SCLC with at least 2 cycles of therapy and a chemotherapy free-interval \[CTFI\] (duration from stop date of the platinum agent in 1L therapy to radiological PD) of ≥30 days. 6. Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator. 7. Has documentation of radiological disease progression on or after the most recent systemic therapy. 8. Has ECOG PS of less than or equal to (≤)1 within 7 days prior to Cycle 1 Day 1 (C1D1). 9. Participants with brain metastasis/leptomeningeal disease are eligible if protocol specified criteria are met. Exclusion Criteria Participants who meet any of the following criteria will be disqualified from entering the study: 1. Has received prior treatment with orlotamab, enoblituzumab, or other B7 homologue 3 (B7-H3) targeted agents, including I-DXd. 2. Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities. 3. Has received any of the comparators used in this study or any topoisomerase I inhibitor. 4. Has inadequate washout period before randomization as specified in the protocol. 5. Has any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event. 6. Has uncontrolled or significant cardiovascular (CV) disease. 7. Has clinically significant corneal disease. 8. All of the following indicators of interstitial lung disease (ILD)/pneumonitis are excluded: 1. Any history of ILD/pneumonitis irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids. 2. Current diagnosis of ILD. 3. Clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out. Radiographic findings may include presence of lung parenchymal fibrosis, combined fibrosis and emphysema (CPFE), and/or interstitial lung abnormalities such as reticular opacities, traction bronchiectasis, honeycombing, or extensive ground glass opacities. Screening computed tomography (CT) scans must be submitted for independent central radiology review and results before randomization. 9. Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders, prior pneumonectomy, or requirement for supplemental oxygen.

Study sites (30)

AR

CA

FL

  • University of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center · Miami, FL 33136Principal Investigator · Study contactMore trials in Miami
  • AdventHealth Orlando, Cancer Institute · Orlando, FL 32804Principal Investigator · Study contactMore trials in Orlando
  • H. Lee Moffitt Cancer Center and Research Institute, Inc · Tampa, FL 33612Principal Investigator · Study contactMore trials in Tampa

IL

  • Rush MD Anderson Cancer Center · Chicago, IL 60612Principal Investigator · Study contactMore trials in Chicago

KY

MA

  • Dana-Farber Cancer Institute · Boston, MA 02216Principal Investigator · Study contactMore trials in Boston

MD

  • University of Maryland Greenebaum Comprehensive Cancer Center · Baltimore, MD 21201Principal Investigator · Study contactMore trials in Baltimore
  • John Hopkins School of Medicine · Baltimore, MD 21287Principal Investigator · Study contactMore trials in Baltimore

MI

MO

  • Mercy Clinic Oncology and Hematology Sindelar Cancer Center · St Louis, MO 63128Principal Investigator · Study contactMore trials in St Louis

NE

  • University of Nebraska Medical Center · Omaha, NE 68198-6811Principal Investigator · Study contactMore trials in Omaha

NH

  • Dartmouth-Hitchcock Medical Center · Lebanon, NH 03766Principal Investigator · Study contactMore trials in Lebanon

NJ

NY

  • Clinical Research Alliance, Inc · Lake Success, NY 11042Principal Investigator · Study contactMore trials in Lake Success
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health Long Island · New York, NY 10016Principal Investigator · Study contactMore trials in New York
  • New York University Cancer Center - Laura and Isaac · New York, NY 10016More trials in New York
  • Montefiore Medical Center Prime · The Bronx, NY 10461Principal Investigator · Study contactMore trials in The Bronx

OH

  • Cleveland Clinic Mercy Hospital · Canton, OH 44708Principal Investigator · Study contactMore trials in Canton
  • Oncology/Hematology Care Clinical Trials, Llc · Cincinnati, OH 45236Principal Investigator · Study contactMore trials in Cincinnati

OR

  • Providence Portland Medical Center · Portland, OR 97213Principal Investigator · Study contactMore trials in Portland

TN

  • THE WEST CLINIC, PLLC dba West Cancer Center · Germantown, TN 38138Principal Investigator · Study contactMore trials in Germantown

TX

  • Houston Methodist Cancer Center · Houston, TX 77030Principal Investigator · Study contactMore trials in Houston
  • University of Texas Md Anderson Cancer Center · Houston, TX 77030Principal Investigator · Study contactMore trials in Houston
  • Texas Oncology, P.A. - Tyler · Tyler, TX 75702Principal Investigator · Study contactMore trials in Tyler

WI