Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18+
Trial acronym
IDeate-Lung02
Clinical summary
Summary
Eligible participants will be randomly allocated to one of two treatment arms.
In the Experimental Arm, participants will receive Ifinatamab deruxtecan (I-DXd) every 3 weeks, which will be given intravenously.
In the Active Comparator Arm, participants will receive physician's choice of treatment, either topotecan, lurbinectedin, or amrubicin.
Conditions
This trial is treating people with extensive-stage small cell lung cancer (ES-SCLC) who have prior treatment with only one platinum-based line with at least 2 cycles of therapy and a chemotherapy free-interval of ≥30 days
Eligibility
Inclusion
Participants must meet all the following criteria to be eligible for randomization into the study:
- Sign and date the informed consent form 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 informed consent form is signed.
- Has histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC).
- The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content.
- 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 of ≥30 days.
- Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator.
- Has documentation of radiological disease progression on or after the most recent systemic therapy.
- Has ECOG PS of ≤1 within 7 days prior to Cycle 1 Day 1 (C1D1).
- Has no evidence of brain or leptomeningeal disease (spinal cord or central nervous system [CNS] metastases) based on history and physical examination. Subjects must require no treatment with steroids or anticonvulsants and have a stable neurologic status for at least 2 weeks prior to the first dose of study drug.
Exclusion
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 homologue 3 (B7-H3) targeted agents, including I-DXd.
- Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities.
- Has received any of the comparators used in this study or any topoisomerase I inhibitor.
- Has inadequate washout period before randomization as specified in the protocol.
- Has any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event.
- Has uncontrolled or significant cardiovascular disease.
- Has clinically significant corneal disease.
- Has 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.
- 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.
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Daiichi Sankyo
Scientific Title
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)
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