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
décembre 2029
07 août 2026
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).
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 (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.
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.