Informations générales (source: ClinicalTrials.gov)
A Phase 1b Study Evaluating the Safety and Efficacy of First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung (DeLLphi-303)
Interventional
Phase 1
Amgen (Voir sur ClinicalTrials)
août 2022
août 2028
02 décembre 2025
This is a phase 1b study to assess the safety and tolerability of tarlatamab in
combination with programmed death ligand (PD-L1) inhibition with and without
chemotherapy.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | St�phane CHAMPIAT | 20/06/2024 08:27:09 | Contacter | ||
Critères
Tous
- Participant has provided informed consent prior to initiation of any study specific
activities/procedures.
- Age greater than or equal to 18 years old at the same time of signing the informed
consent.
- Histologically or cytologically confirmed Extensive Stage Small Cell Lung Cancer
(ES-SCLC) and no prior systemic treatment for ES-SCLC.
- Participants with prior treatment for limited-stage SCLC (LS-SCLC) are permitted.
- Eastern Cooperative Oncology Group (ECOG) 0 to 1.
- Participants with treated asymptomatic brain metastases are eligible provided they
meet defined criteria.
- Adequate organ function as defined in protocol.
Exclusion Criteria:
- History of other malignancy within the past 2 years with exceptions.
- Major surgery within 28 days of study day 1.
- Untreated or symptomatic brain metastases and leptomeningeal disease.
- Participants who experienced recurrent grade 2 pneumonitis or severe or
life-threatening immune-mediated adverse events or infusion-related reactions
including those that lead to permanent discontinuation while on treatment with
immuno-oncology agents.
- History of immune-related colitis.
- History or evidence of interstitial lung disease or active, non-infectious
pneumonitis.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any
other form of immunosuppressive therapy within 7 days prior to the first dose of
study treatment.
- Participants 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
- NOTE: Simple urinary tract infections and uncomplicated bacterial pharyngitis are
permitted if responding to an active treatment and after consultation with Medical
Monitor. Participants requiring oral antibiotics who have been afebrile for >24
hours, have no leukocytosis, nor clinical signs of infection are eligible. Screening
for chronic infectious conditions is not required.
- History of hypophysitis or pituitary dysfunction.
- History of solid organ transplantation or allogeneic hematopoietic stem cell
transplantation.
- Active autoimmune disease that has required systemic treatment (except replacement
therapy) within the past 2 years or any other diseases requiring immunosuppressive
therapy while on study. Participants with Type I diabetes, vitiligo, psoriasis,
hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are
permitted.