Informations générales (source: ClinicalTrials.gov)
A Phase 3, Open-label, Multicenter, Randomized Study of Tarlatamab in Combination With Durvalumab vs Durvalumab Alone in Subjects With Extensive-Stage Small-Cell Lung Cancer Following Platinum, Etoposide and Durvalumab (DeLLphi-305) (DeLLphi-305)
Interventional
Phase 3
Amgen (Voir sur ClinicalTrials)
juin 2024
juillet 2028
04 avril 2025
The primary objective of this study is to compare the efficacy of tarlatamab plus
durvalumab with durvalumab alone on prolonging overall survival (OS).
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 Cochin | Contact (sur clinicalTrials) | ||||
| CHI DE CRETEIL | 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 | |||||
| Centre Hospitalier - Le Mans - 72000 - Le Mans - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Regional Universitaire de Brest - Hopital Morvan - 29200 - Brest - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec - 44800 - Saint Herblain - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil - 67091 - Strasbourg Cedex - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Toulouse - Hopital Larrey - 31059 - Toulouse Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Nord - 13915 - Marseille Cedex 20 - France | Contact (sur clinicalTrials) | ||||
| Centre Leon Berard - 69008 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Clinique Teissier - 59300 - Valenciennes - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonie - 33000 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Institut regional du Cancer Montpellier - 34298 - Montpellier Cedex 5 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion:
- Participant has provided informed consent prior to initiation of any study specific
activities/procedures.
- Age >= 18 years (or >= legal adult age within the country if it is older than 18
years).
- Completed 3-4 cycles of platinum-etoposide chemotherapy with concurrent durvalumab
as first-line treatment of extensive-stage (ES)-SCLC prior to enrollment, without
disease progression (ongoing response or stable disease) per Response Evaluation
Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
- Minimum life expectancy > 12 weeks.
- Toxicities attributed to prior anti-cancer therapy resolved to grade ≤ 1, unless
otherwise specified, excluding alopecia or fatigue.
- Adequate organ function.
- Histologically or cytologically documented extensive-stage disease (American Joint
Committee on Cancer, 2017, IV small-cell lung cancer (SCLC) [T any, N any, M1
a/b/c]), or T3 to T4 due to multiple lung nodules that are too extensive or have
tumor/nodal volume that is too large to be encompassed in a tolerable radiation
plan. Participants with prior limited-stage (LS)-SCLC are allowed if the interval is
> 6 months since the end of previous therapy and progression, in discussion with the
medical monitor.
Exclusion
- Symptomatic central nervous system (CNS) metastases, or leptomeningeal disease.
Participants with treated brain metastases are eligible as per protocol.
- Prior history of severe or life-threatening events from any immune-mediated therapy.
- History of other malignancy within the past 2 years, with some exceptions as per
protocol.
- Active or prior documented autoimmune or inflammatory disorders as per protocol.
- Myocardial infarction and/or symptomatic congestive heart failure (New York Heart
Association > class II) within 6 months of first dose of study treatment.
- History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 6
months of first dose of study treatment.
- Evidence of interstitial lung disease (ILD) or active, non-infectious pneumonitis.
- History of solid organ transplant.
- Major surgical procedures within 28 days of first dose of study treatment.
- Known human immunodeficiency virus (HIV) infection (participants with HIV infection
on antiviral therapy and undetectable viral load are permitted with a requirement
for regular monitoring for reactivation for the duration of treatment on study),
hepatitis C infection (participants with hepatitis C that achieve a sustained
virologic response after antiviral therapy are allowed), or hepatitis B infection
(participants with hepatitis B surface antigen [HBsAg] or core antibody that achieve
sustained virologic response with antiviral therapy are permitted with a requirement
for regular monitoring for reactivation for the duration of treatment on the study).
- Receiving systemic corticosteroid therapy or any other form of immunosuppressive
therapy within 14 days prior to first dose of study treatment.
- History of allergic reactions or acute hypersensitivity reaction to antibody
therapies, platinum chemotherapy, or etoposide.
- Participant with symptoms and/or clinical signs and/or radiographic signs that
indicate an acute and/or uncontrolled active systemic infection within 7 days prior
to the first dose of study treatment.
- Participant has known active infection requiring parenteral antibiotic treatment.
Upon completion of parenteral antibiotics and resolution of symptoms, the
participant may be considered eligible for the study from an infection standpoint.
- Treatment with live virus, including live-attenuated vaccination, within 4 weeks
prior to the first dose of study treatment. Inactive vaccines (e.g., non-live or
non-replicating agent) and live viral non-replicating vaccines (e.g., Jynneos for
Monkeypox infection) within 30 days prior to first dose of study treatment.
- Prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3)
pathway.
- Receiving another anti-cancer therapy. Adjuvant hormonal therapy for resected breast
cancer is permitted.
- Treatment in an alternative investigational trial within 28 days prior to
enrollment.
- Has received or is planning to receive consolidative chest radiation for extensive
stage disease.
- Female participants of childbearing potential unwilling to use protocol specified
method of contraception during treatment as per protocol.
- Female participants who are breastfeeding or who plan to breastfeed while on study
as per protocol.
- Female participants planning to become pregnant or donate eggs while on study as per
protocol.
- Female participants of childbearing potential with a positive pregnancy test
assessed at screening by a highly sensitive serum pregnancy test.
- Male participants with a female partner of childbearing potential who are unwilling
to practice sexual abstinence (refrain from heterosexual intercourse) or use
contraception during treatment as per protocol.
- Male participants with a pregnant partner who are unwilling to practice abstinence
or use a condom during treatment as per protocol.
- Male participants unwilling to abstain from donating sperm during treatment as per
protocol.
- Participant has known sensitivity to any of the products or components to be
administered during dosing.
- Participant has known sensitivity to any of the products or components to be
administered during dosing.
- History or evidence of any other clinically significant disorder, condition or
disease that, in the opinion of the investigator or physician if consulted, would
pose a risk to participant safety or interfere with the study evaluation,
procedures, or completion.
- Participant likely to not be available to complete all protocol-required study
visits or procedures, and/or to comply with all required study procedures (eg,
Clinical Outcome Assessments) to the best of the participant and investigator's
knowledge. Participants who are unable to complete clinical outcome assessments are
eligible.
- Participant has provided informed consent prior to initiation of any study specific
activities/procedures.
- Age >= 18 years (or >= legal adult age within the country if it is older than 18
years).
- Completed 3-4 cycles of platinum-etoposide chemotherapy with concurrent durvalumab
as first-line treatment of extensive-stage (ES)-SCLC prior to enrollment, without
disease progression (ongoing response or stable disease) per Response Evaluation
Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
- Minimum life expectancy > 12 weeks.
- Toxicities attributed to prior anti-cancer therapy resolved to grade ≤ 1, unless
otherwise specified, excluding alopecia or fatigue.
- Adequate organ function.
- Histologically or cytologically documented extensive-stage disease (American Joint
Committee on Cancer, 2017, IV small-cell lung cancer (SCLC) [T any, N any, M1
a/b/c]), or T3 to T4 due to multiple lung nodules that are too extensive or have
tumor/nodal volume that is too large to be encompassed in a tolerable radiation
plan. Participants with prior limited-stage (LS)-SCLC are allowed if the interval is
> 6 months since the end of previous therapy and progression, in discussion with the
medical monitor.
Exclusion
- Symptomatic central nervous system (CNS) metastases, or leptomeningeal disease.
Participants with treated brain metastases are eligible as per protocol.
- Prior history of severe or life-threatening events from any immune-mediated therapy.
- History of other malignancy within the past 2 years, with some exceptions as per
protocol.
- Active or prior documented autoimmune or inflammatory disorders as per protocol.
- Myocardial infarction and/or symptomatic congestive heart failure (New York Heart
Association > class II) within 6 months of first dose of study treatment.
- History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 6
months of first dose of study treatment.
- Evidence of interstitial lung disease (ILD) or active, non-infectious pneumonitis.
- History of solid organ transplant.
- Major surgical procedures within 28 days of first dose of study treatment.
- Known human immunodeficiency virus (HIV) infection (participants with HIV infection
on antiviral therapy and undetectable viral load are permitted with a requirement
for regular monitoring for reactivation for the duration of treatment on study),
hepatitis C infection (participants with hepatitis C that achieve a sustained
virologic response after antiviral therapy are allowed), or hepatitis B infection
(participants with hepatitis B surface antigen [HBsAg] or core antibody that achieve
sustained virologic response with antiviral therapy are permitted with a requirement
for regular monitoring for reactivation for the duration of treatment on the study).
- Receiving systemic corticosteroid therapy or any other form of immunosuppressive
therapy within 14 days prior to first dose of study treatment.
- History of allergic reactions or acute hypersensitivity reaction to antibody
therapies, platinum chemotherapy, or etoposide.
- Participant with symptoms and/or clinical signs and/or radiographic signs that
indicate an acute and/or uncontrolled active systemic infection within 7 days prior
to the first dose of study treatment.
- Participant has known active infection requiring parenteral antibiotic treatment.
Upon completion of parenteral antibiotics and resolution of symptoms, the
participant may be considered eligible for the study from an infection standpoint.
- Treatment with live virus, including live-attenuated vaccination, within 4 weeks
prior to the first dose of study treatment. Inactive vaccines (e.g., non-live or
non-replicating agent) and live viral non-replicating vaccines (e.g., Jynneos for
Monkeypox infection) within 30 days prior to first dose of study treatment.
- Prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3)
pathway.
- Receiving another anti-cancer therapy. Adjuvant hormonal therapy for resected breast
cancer is permitted.
- Treatment in an alternative investigational trial within 28 days prior to
enrollment.
- Has received or is planning to receive consolidative chest radiation for extensive
stage disease.
- Female participants of childbearing potential unwilling to use protocol specified
method of contraception during treatment as per protocol.
- Female participants who are breastfeeding or who plan to breastfeed while on study
as per protocol.
- Female participants planning to become pregnant or donate eggs while on study as per
protocol.
- Female participants of childbearing potential with a positive pregnancy test
assessed at screening by a highly sensitive serum pregnancy test.
- Male participants with a female partner of childbearing potential who are unwilling
to practice sexual abstinence (refrain from heterosexual intercourse) or use
contraception during treatment as per protocol.
- Male participants with a pregnant partner who are unwilling to practice abstinence
or use a condom during treatment as per protocol.
- Male participants unwilling to abstain from donating sperm during treatment as per
protocol.
- Participant has known sensitivity to any of the products or components to be
administered during dosing.
- Participant has known sensitivity to any of the products or components to be
administered during dosing.
- History or evidence of any other clinically significant disorder, condition or
disease that, in the opinion of the investigator or physician if consulted, would
pose a risk to participant safety or interfere with the study evaluation,
procedures, or completion.
- Participant likely to not be available to complete all protocol-required study
visits or procedures, and/or to comply with all required study procedures (eg,
Clinical Outcome Assessments) to the best of the participant and investigator's
knowledge. Participants who are unable to complete clinical outcome assessments are
eligible.