Phase 3 study comparing tarlatamab to standard treatment in patients with relapsed small cell lung cancer (SCLC).

Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, Poland, Portugal, Romania, Singapore, Spain, Switzerland, Taiwan, Turkey, United Kingdom, United States (ICTRP)

Identifiant de l'essai ICTRP
NCT05740566 (ICTRP)

Titre officiel (approuvé par le comité d'éthique)
A Randomized, Open-label, Phase 3 Study of Tarlatamab Compared With Standard of Care in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy (DeLLphi-304) (BASEC)

Titre académique
A Randomized, Open-label, Phase 3 Study of Tarlatamab Compared With Standard of Care in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy (ICTRP)

Titre public
Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer (ICTRP)

Maladie en cours d'investigation
Small Cell Lung Cancer (SCLC) (ICTRP)

Intervention étudiée
Drug: TarlatamabDrug: LurbinectedinDrug: TopotecanDrug: Amrubicin (ICTRP)

Type d'essai
Interventional (ICTRP)

Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Critères d'inclusion/exclusion
Inclusion Criteria:

- Participant has provided informed consent prior to initiation of any study specific
activities/procedures.

- Age = 18 years (or legal adult age within country, whichever is older) at the time
of signing the informed consent.

- Histologically or cytologically confirmed SCLC with demonstrated progression or
relapse.

- Participants who progressed or recurred following 1 platinum-based regimen.

- Measurable disease as defined per RECIST 1.1 within the 21-day screening period.

- Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.

- Minimum life expectancy of 12 weeks.

- Adequate organ function.

Exclusion Criteria:

- Disease Related

- Symptomatic central nervous system (CNS) metastases with exceptions defined in
the protocol.

- Diagnosis or evidence of leptomeningeal disease.

- Prior history of immune checkpoint inhibitors resulting in events defined in
the protocol.

- Other Medical Conditions

- Active autoimmune disease that has required systemic treatment (except
replacement therapy) within the past 2 years or any other diseases requiring
immunosuppressive therapy.

- History of solid organ transplantation.

- History of other malignancy within the past 2 years, with exceptions defined in
the protocol.

- Myocardial infarction and/or symptomatic congestive heart failure (New York
Heart Association > class II) within 12 months prior to first dose of study
treatment.

- History of arterial thrombosis (eg, stroke or transient ischemic attack) within
12 months prior to first dose of study treatment.

- Presence or history of viral infection based on criteria per protocol.

- Receiving systemic corticosteroid therapy or any other form of
immunosuppressive therapy within 7 days prior to first dose of study treatment.

- Symptoms and/or radiographic signs that indicate an acute and/or uncontrolled
active systemic infection requiring antibiotics within 7 days prior to the
first dose study treatment.

- Evidence of interstitial lung disease or active, non-infectious pneumonitis.

- Prior/Concomitant Therapy

- Prior therapy with tarlatamab or any of the standard of care chemotherapy
included as part of this trial or participation in any tarlatamab or any other
DLL3 targeted agent clinical trial.

- Prior therapy with any selective inhibitor of the DLL3 pathway.

- Participant received more than one prior systemic therapy regimen for SCLC.

- Prior anti-cancer therapy within 21 days prior to first dose of study treatment
with exceptions defined in protocol.

- Current anti-cancer therapy such as chemotherapy, immunotherapy, or targeted
therapy with exceptions.

- Use of herbal or prescription/non-prescription medications known to inhibit
membrane transporters P-glycoprotein (P-gp) and/or breast cancer resistance
protein (BCRP) within 7 days prior to the first dose of study treatment.

- Use of herbal or prescription/non-prescription medications known to be moderate
or strong inhibitors of cytochrome P450 3A (CYP3A) enzymes within 7 days prior
to the first dose of study treatment.

- Use of herbal or prescription/non-prescription medications known to be moderate
or strong inducers of CYP3A enzymes within 28 days prior to first dose of study
treatment.

- Participants who have reached the limit dose of prior treatment with
cardiotoxic drugs.

- Major surgical procedures within 28 days prior to first dose of study
treatment.

- Live and live-attenuated vaccines within 14 days prior to the start of study
treatment.

- Inactive vaccines and live viral non-replicating vaccines within 3 days prior
to the first dose of study treatment.

- Currently receiving treatment in another investigational device or drug study,
or less than 30 days since ending treatment on another investigational device
or drug study(ies). Other investigational procedures while participating in
this study are excluded.

- Diagnostic Assessments

- Any previous diagnosis of transformed non-small cell lung cancer (NSCLC),
epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that
has transformed to SCLC, with exceptions defined in the protocol.

- Other Exclusions

- Female participants of childbearing potential unwilling to use protocol
specified method of contraception during treatment and for an additional 60
days after the last dose of tarlatamab.

- Female participants who are breastfeeding or who plan to breastfeed while on
study through 60 days after the last dose of tarlatamab.

- Female participants planning to become pregnant or donate eggs while on study
through 60 days after the last dose of tarlatamab.

- Female participants of childbearing potential with a positive pregnancy test
assessed at screening by a 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 and for an additional 60 days after the
last dose of tarlatamab.

- Male participants with a pregnant partner who are unwilling to practice
abstinence or use a condom during treatment and for an additional 60 days after
the last dose of tarlatamab.

- Male participants unwilling to abstain from donating sperm during treatment and
for an additional 60 days after the last dose of tarlatamab.

- Contraception requirements for male and female participants receiving SOC
therapies are based on regional prescribing information.

- Breastfeeding restrictions for female participants receiving SOC therapies are
based on regional prescribing information.

- Participant has known sensitivity or is contraindicated to any of the products
or components to be administered during dosing.

- Participant likely to not be available to complete all protocol-required study
visits or procedures, and/or to comply with all required study procedures.

- History or evidence of any other clinically significant disorder, condition or
disease determined by the investigator or Amgen physician that would pose a
risk to the subject safety or interfere with the study evaluation.. (ICTRP)

non disponible

Critères d'évaluation principaux et secondaires
Overall Survival (OS) (ICTRP)

Progression Free Survival (PFS);Change from Baseline In Selected Functional Scales and Disease Symptom Items Included in Cancer Quality of Life Questionnaire (EORTC QLQ-C30);Change from Baseline in Selected Disease Symptoms Included in Lung Cancer Quality of Life Questionnaire (EORTC-QLQ-LC13);Overall Response (OR);Disease Control (DC);Duration of Response (DOR);PFS;OS;Incidence of Treatment-Emergent Adverse Events (TEAE);Serum Concentrations of Tarlatamab;Number of Participants Who Experience Anti-tarlatamab Antibodies;Change from Baseline in Pain Severity as Measured by Brief Pain Inventory - Short Form (BPI-SF);Patient Perceived Health at Each Assessment Visit Using Visual Analogue Scale (VAS);Change from Baseline in Patient Perceived Health Using Visual Analog Scale (VAS);Responses to Patient-Reported Adverse Events Questionnaire (PRO-CTCAE);Change from Baseline in Symptom Severity as Measured by Patient Global Impression of Severity (PGIS) Questionnaire;Change from Baseline in Symptoms and Overall Status as Measured by Patient Reported Impression of Change (PGIC) Questionnaire;Change from Baseline in Symptom Bother as Measured by Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire (ICTRP)

Date d'enregistrement
non disponible

Inclusion du premier participant
non disponible

Sponsors secondaires
non disponible

Contacts supplémentaires
MD, Amgen (ICTRP)

ID secondaires
20210004 (ICTRP)

Résultats-Données individuelles des participants
non disponible

Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT05740566 (ICTRP)