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) (IDeate-Lung02)
Interventional
Phase 3
Daiichi Sankyo (Voir sur ClinicalTrials)
mai 2024
février 2029
05 décembre 2024
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 dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Tenon | Principal Investigator | Contact (sur clinicalTrials) | |||
| CHI DE CRETEIL | Principal Investigator | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT CURIE | Principal Investigator | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Principal Investigator | Contact (sur clinicalTrials) | |||
| HOPITAL FOCH | Principal Investigator | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Assistance Publique-Hăpitaux de Marseille - 13005 - Marseille - France | Principal Investigator | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - 69008 - Lyon - France | Principal Investigator | Contact (sur clinicalTrials) | |||
| Ch de Mulhouse - Hăpital Emile Muller - 68100 - Mulhouse Cedex - France | Principal Investigator | Contact (sur clinicalTrials) | |||
| Chu Bordeaux - 33075 - Bordeaux cedex - France | Principal Investigator | Contact (sur clinicalTrials) | |||
| Chu Limoges - Hopital Du Cluzeau - 87042 - Limoges cedex - France | Principal Investigator | Contact (sur clinicalTrials) | |||
| Chu Nantes - Hăpital Guillaume Et Renă Laănnec - 44805 - Saint Herblain - France | Principal Investigator | Contact (sur clinicalTrials) | |||
| Chu Rennes - Hopital Pontchaillou - 35000 - Rennes cedex 09 - France | Principal Investigator | Contact (sur clinicalTrials) | |||
| Hopital Albert Calmette - Chu Lille - 59037 - Lille Cedex - France | Principal Investigator | Contact (sur clinicalTrials) | |||
| Hopital Arnaud de Villeneuve - 34295 - Montpellier cedex 05 - France | Principal Investigator | Contact (sur clinicalTrials) | |||
| Institut de Cancerologie de La Loire - 42270 - Saint-Priest-En-Jarez - France | Principal Investigator | Contact (sur clinicalTrials) | |||
| Institut Régional Du Cancer de Montpellier - 34298 - Montpellier - France | Principal Investigator | Contact (sur clinicalTrials) | |||
| Institut Sainte Catherine - 84918 - Avignon Cedex 9 - France | Principal Investigator | Contact (sur clinicalTrials) | |||
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 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.
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 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.
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.