Lung Cancer Clinical Trial
Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
This study intends to define the recommended Phase 2 dose of DS-7300a based on the efficacy, safety, and pharmacokinetics (PK) results observed in participants with Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) and to investigate DS7300a anti-tumor activity in this population.
In this study, eligible participants will be randomized in a 1:1 ratio to receive one of the two dose levels of I-DXd. Randomization will be stratified by:
Prior receipt or of an anti-programmed death-ligand 1 (PD-[L]1) antibody (yes/no)
The chemotherapy-free interval (CTFI) from completion of the first-line therapy to the date of documented radiological Progressive Disease of <90 days vs. ≥90 days in second-line participants as well as the number of previous lines. Thus, the stratification factor includes three categories: (1) second-line participants with CTFI <90 days, (2) second-line participants with CTFI ≥90 days, and (3) third- and fourth-line participants.
Participants must meet all 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.
Participant must have at least one lesion, not previously irradiated, amenable to core biopsy.
Male or female subjects aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is >18 years old).
Histologically or cytologically documented ES-SCLC.
At least one measurable lesion according to RECIST v1.1 as assessed by the investigator.
Prior therapy with at least one platinum-based line as systemic therapy for extensive-stage disease with at least two cycles of therapy (except in the case of early objective PD).
Documentation of radiological disease progression on or after most recent systemic therapy.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Participants who meet any of the following criteria will be disqualified from entering the study:
Prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents.
Prior treatment with an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan).
Clinically active brain metastases, spinal cord compression or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.
Any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or arterial thromboembolic event.
Clinically significant corneal disease.
Uncontrolled or significant cardiovascular disease.
History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses,
Chronic steroid treatment (maximum dose of 10 mg daily prednisone equivalent), except for low-dose inhaled steroids (for asthma/COPD) or topical steroids (for mild skin conditions) or intra-articular steroid injections.
History of malignancy other than SCLC within the 3 years prior to enrollment, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, superficial gastrointestinal (GI) tract tumors and non-muscle invasive bladder cancer curatively resected by endoscopic surgery.
History of allogeneic bone marrow, stem cell, or solid organ transplant.
Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE V5.0), Grade ≤1 or baseline.
History of hypersensitivity to the drug substances, inactive ingredients in the drug product or severe hypersensitivity reactions to other monoclonal antibodies.
Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection (including HIV infection).
Active or uncontrolled hepatitis B or C infection.
Active, known, or suspected autoimmune disease.
Any evidence of severe or uncontrolled systemic diseases (including active bleeding diatheses, psychiatric illness/social situations, substance abuse).
Has received a live vaccine within 30 days prior to the first dose of study drug.
Female who is pregnant or breast-feeding or intends to become pregnant during the study.
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 36 Locations for this study
Springdale Arkansas, 72762, United States More Info
Jacksonville Florida, 32256, United States More Info
Detroit Michigan, 48202, United States More Info
Grand Rapids Michigan, 49503, United States More Info
Hackensack New Jersey, 07601, United States More Info
New York New York, 10021, United States More Info
Durham North Carolina, 27710, United States More Info
Houston Texas, 77090, United States More Info
Wuhan Hubei, 43002, China More Info
Changchun Jilin, 13000, China More Info
Linyi City Shandong, 27600, China More Info
Chengdu Sichuan, 61113, China More Info
Shanghai , 20003, China More Info
Lyon Cedex , 69373, France More Info
Marseille , 13915, France More Info
Montpellier , 34295, France More Info
Paris , 75020, France More Info
Paris , 94000, France More Info
Kashiwa-shi Chiba-Ken, 277-8, Japan More Info
Osaka-shi Osaka-Fu, 541-8, Japan More Info
Osakasayama-shi Osaka-Fu, 589-8, Japan More Info
Sunto-gun Shizuoka-Ken, 411-8, Japan More Info
Chuo Ku Tokyo-To, 104-0, Japan More Info
Koto-ku Tokyo-To, 135-8, Japan More Info
Goyang-si Gyeonggi-do, 10408, Korea, Republic of More Info
Seoul , 03080, Korea, Republic of More Info
Seoul , 05505, Korea, Republic of More Info
A Coruña , 15006, Spain More Info
Barcelona , 08035, Spain More Info
Madrid , 28034, Spain More Info
Madrid , 28041, Spain More Info
Sevilla , 41009, Spain More Info
Kaohsiung City , 833, Taiwan More Info
Taichung , 40705, Taiwan More Info
Taipei , 10002, Taiwan More Info
Taipei , 112, Taiwan More Info
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.