Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 3
Daiichi Sankyo (Voir sur ClinicalTrials)
mai 2024
février 2029
22 juillet 2026
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | David PLANCHARD | 22/07/2026 18:35:05 | Contacter | ||
Critères
Tous
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 prior to the start of any study-specific
qualification procedures.
2. Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time
the informed consent form 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
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 ≤1 within 7 days prior to Cycle 1 Day 1 (C1D1).
9. 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 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 disease.
7. Has clinically significant corneal disease.
8. Has any history of ILD/pneumonitis irrespective of steroid use, or current ILD, or
suspected ILD, or ILD that cannot be ruled out by imaging at Screening. Participants
may be eligible if they had history of radiation pneumonitis that did not require
steroids.
Examples of suspected ILD/pneumonitis by imaging include the presence of lung
parenchymal fibrosis, such as combined pulmonary fibrosis and emphysema (CPFE) and
any radiographic features consistent with ILA, including but not limited to,
extensive ground glass opacities, reticular opacities, traction bronchiectasis, and
honeycombing.
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.
Participants must meet all the following criteria to be eligible for randomization into
the study:
1. Sign and date the informed consent form prior to the start of any study-specific
qualification procedures.
2. Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time
the informed consent form 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
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 ≤1 within 7 days prior to Cycle 1 Day 1 (C1D1).
9. 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 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 disease.
7. Has clinically significant corneal disease.
8. Has any history of ILD/pneumonitis irrespective of steroid use, or current ILD, or
suspected ILD, or ILD that cannot be ruled out by imaging at Screening. Participants
may be eligible if they had history of radiation pneumonitis that did not require
steroids.
Examples of suspected ILD/pneumonitis by imaging include the presence of lung
parenchymal fibrosis, such as combined pulmonary fibrosis and emphysema (CPFE) and
any radiographic features consistent with ILA, including but not limited to,
extensive ground glass opacities, reticular opacities, traction bronchiectasis, and
honeycombing.
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.