Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT06211036

Studienbeginn:
Juni 2024

Letztes Update:
21.06.2024

Wirkstoff:
Tarlatamab, Durvalumab

Indikation (Clinical Trials):
Lung Neoplasms, Small Cell Lung Carcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Amgen

Collaborator:
-

Studienleiter

MD
Study Director
Amgen

Kontakt

Amgen Call Center
Kontakt:
Phone: 866-572-6436
E-Mail: medinfo@amgen.com» Kontaktdaten anzeigen

Studienlocations
(3 von 11)

Northeast Georgia Medical Center
30501 Gainesville
United StatesRekrutierend» Google-Maps

Our Lady of the Lake Cancer Institute
70808 Baton Rouge
United StatesRekrutierend» Google-Maps

Cancer and Hematology Centers of Western Michigan
49503 Grand Rapids
United StatesRekrutierend» Google-Maps

Nebraska Cancer Specialists
68130 Omaha
United StatesRekrutierend» Google-Maps

Astera Cancer Care
08816 East Brunswick
United StatesRekrutierend» Google-Maps

Baptist Cancer Center Memphis Thoracic
38120 Memphis
United StatesRekrutierend» Google-Maps

Jilin Cancer Hospital
130012 Changchun
ChinaRekrutierend» Google-Maps

Kurume University Hospital
830-0011 Kurume-shi
JapanRekrutierend» Google-Maps

Universitaetsspital Basel
4052 Basel
SwitzerlandRekrutierend» Google-Maps

Medical Park Seyhan Hastanesi
33200 Mersin
TurkeyRekrutierend» Google-Maps

VM Medical Park Mersin Hastanesi
33200 Mersin
TurkeyRekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

Brief Summary:

The primary objective of this study is to compare the efficacy of tarlatamab plus durvalumab

with durvalumab alone on prolonging overall survival (OS).

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).

- 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]),

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.

- 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

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 withing 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.

- Participant likely not to be available to complete all protocol-required study visits

or procedures to the best of the participant and investigator's knowledge.

- 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.

Studien-Rationale

Primary outcome:

1. OS (Time Frame - Up to approximately 3 years)

Secondary outcome:

1. Progression Free Survival (PFS) (Time Frame - Up to approximately 3 years)

2. Overall Response (OR) (Time Frame - Up to approximately 3 years)

3. Disease Control (DC) Rate (Time Frame - Up to approximately 3 years)

4. Duration of Response (DoR) (Time Frame - Up to approximately 3 years)

5. PFS at 6 Months (Time Frame - 6 months)

6. PFS at 1 Year (Time Frame - 1 year)

7. PFS at 2 Years (Time Frame - 2 years)

8. OS at 6 Months (Time Frame - 6 months)

9. OS at 1 Year (Time Frame - 1 year)

10. OS at 2 Years (Time Frame - 2 years)

11. OS at 3 Years (Time Frame - 3 years)

12. Time to Progression (TTP) (Time Frame - Up to approximately 3 years)

13. Number of Participants with Treatment-emergent Adverse Events (TEAEs) (Time Frame - Up to approximately 9 months)

14. Number of Participants with TEAEs Grade 3 or Above per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. (Time Frame - Up to approximately 3 years)

15. Number of Participants with Serious TEAEs (Time Frame - Up to approximately 3 years)

16. Number of Participants with TEAEs Leading to Discontinuation of Treatment (Time Frame - Up to approximately 3 years)

17. Number of Participants with Fatal TEAEs (Time Frame - Up to approximately 3 years)

18. Number of Participants with Treatment-related Adverse Events (AEs) (Time Frame - Up to approximately 9 months)

19. Number of Participants with Adverse Events of Interest (EOI) (Time Frame - Up to approximately 9 months)

20. Serum Concentrations of Tarlatamab (Time Frame - Day 1 up to approximately 6 months)

21. Number of Participants with Antitarlatamab Antibody Formation (Time Frame - Up to approximately 9 months)

22. Time to First Deterioration (TTD) for Physical Function as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC-QLQ-C30) (Time Frame - Up to approximately 9 months)

23. Change in Disease Symptoms of Cough as Measured Using EORTC-QLQ LC13 (Time Frame - Up to 12 months)

24. Change in Disease Symptoms of Chest Pain as Measured Using EORTC-QLQ LC13 (Time Frame - Up to 12 months)

25. Change in Disease Symptoms of Dyspnea as Measured Using EORTC-QLQ LC13 (Time Frame - Up to 12 months)

26. TTD for Global Health Status as Measured by EORTC-QLQ-C30 (Time Frame - Up to approximately 9 months)

27. TTD for Quality of Life as Measured by EORTC-QLQ-C30 (Time Frame - Up to approximately 9 months)

Studien-Arme

Experimental: Tarlatamab in Combination With Durvalumab
Participants will receive tarlatamab once every 2 weeks (Q2W) and durvalumab once every 4 weeks (Q4W).
Active Comparator: Durvalumab Alone
Participants will receive durvalumab Q4W alone.

Geprüfte Regime

Tarlatamab (AMG 757):
Intravenous (IV) infusion
Durvalumab:
IV infusion

Quelle: ClinicalTrials.gov

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