JOURNAL ONKOLOGIE – STUDIE

DeLLphi-306

Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)

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

Rekrutierend

NCT-Nummer:
NCT06117774

Studienbeginn:
Februar 2024

Letztes Update:
01.05.2024

Wirkstoff:
Tarlatamab, Placebo

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 25)

FirstHealth Cancer Center
28374 Pinehurst
United StatesRekrutierend» Google-Maps

West Virginia University Health Sciences Center
26506 Morgantown
United StatesRekrutierend» Google-Maps

Mengchao Hepatobiliary Hospital of Fujian Medical University
350025 Fuzhou
ChinaRekrutierend» Google-Maps

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
430030 Wuhan
ChinaRekrutierend» Google-Maps

Shandong Provincial Cancer Hospital
250117 Jinan
ChinaRekrutierend» Google-Maps

National Hospital Organization Nagoya Medical Center
460-0001 Nagoya-shi
JapanRekrutierend» Google-Maps

National Cancer Center Hospital East
277-8577 Kashiwa-shi
JapanRekrutierend» Google-Maps

National Hospital Organization Shikoku Cancer Center
791-0280 Matsuyama-shi
JapanRekrutierend» Google-Maps

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

National Hospital Organization Hokkaido Cancer Center
003-0804 Sapporo-shi
JapanRekrutierend» Google-Maps

Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
241-8515 Yokohama-shi
JapanRekrutierend» Google-Maps

Sendai Kousei Hospital
980-0873 Sendai-shi
JapanRekrutierend» Google-Maps

Niigata Cancer Center Hospital
951-8566 Niigata-shi
JapanRekrutierend» Google-Maps

Okayama University Hospital
700-8558 Okayama-shi
JapanRekrutierend» Google-Maps

Kansai Medical University Hospital
573-1191 Hirakata-shi
JapanRekrutierend» Google-Maps

Osaka International Cancer Institute
541-8567 Osaka-shi
JapanRekrutierend» Google-Maps

Kindai University Hospital
589-8511 Osakasayama-shi
JapanRekrutierend» Google-Maps

Saitama Medical University International Medical Center
350-1298 Hidaka-Shi
JapanRekrutierend» Google-Maps

Dokkyo Medical University Hospital
321-0293 Shimotsuga-gun
JapanRekrutierend» Google-Maps

Chungbuk National University Hospital
28644 Cheongju Chungbuk
Korea, Republic ofRekrutierend» Google-Maps

Kaohsiung Medical University Chung-Ho Memorial Hospital
80756 Kaohsiung
TaiwanRekrutierend» Google-Maps

Taipei Veterans General Hospital
11217 Taipei
TaiwanRekrutierend» Google-Maps

Izmir Ekonomi Universitesi Medical Point Hastanesi
35575 Izmir
TurkeyRekrutierend» Google-Maps

Kocaeli Universitesi Tip Fakultesi Hastanesi
41380 Kocaeli
TurkeyRekrutierend» Google-Maps

Medical Park Seyhan 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 with placebo as

assessed by progression free survival (PFS).

Inclusion Criteria: -Participants are eligible to be included in the study only if all of

the following criteria apply:

- Participant has provided informed consent prior to initiation of any study specific

activities/procedures.

- Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).

- Histologically or cytologically confirmed small-cell lung cancer (SCLC).

- Diagnosed and treated for LS-SCLC with concurrent chemotherapy and radiotherapy.

- Has completed chemoradiotherapy without progression per Response Evaluation Criteria

in Solid Tumors v1.1 (RECIST 1.1.) (ie, achieved complete response [CR], partial

response [PR], or stable disease [SD]).

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

- Minimum life expectancy of 12 weeks.

- Adequate organ function.

- Toxicities attributed to concurrent chemoradiotherapy resolved to grade ≤ 1, unless

otherwise specified. Excluding alopecia or fatigue.

Exclusion Criteria: -Participants are excluded from the study if any of the following

criteria apply:

Disease Related

- Extensive-stage SCLC (ES-SCLC).

- 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, or mixed SCLC NSCLC histology.

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

Medical Conditions

- History of other malignancy within the past 2 years, with certain exceptions.

- History of solid organ transplantation.

- Myocardial infarction and/or symptomatic congestive heart failure (New York Heart

Association > class II) within 6 months prior to first dose of study treatment.

- History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6

months prior to first dose of study treatment.

- Exclusion of human immunodeficiency virus (HIV) and hepatitis infection based on

criteria per protocol.

- 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.

Prior/Concomitant Therapy

- Received sequential chemotherapy and thoracic radiotherapy (no overlap of thoracic

radiotherapy with chemotherapy) during chemoradiation.

- Prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway.

- Prior history of severe or life-threatening events from any immune-mediated therapy.

- Receiving another anti-cancer therapy. Adjuvant hormonal therapy for resected breast

cancer is permitted.

- Receiving systemic corticosteroid therapy or any other form of immunosuppressive

therapy within 7 days prior to enrollment.

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

- Treatment with live virus, including live-attenuated vaccination, within 14 days prior

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

vaccines within 3 days prior to first dose of study treatment.

Prior/Concurrent Clinical Study Experience

• Treatment in an alternative investigational trial within 28 days prior to enrollment.

Other Exclusions

- Female participants of childbearing potential unwilling to use protocol specified

method of contraception during treatment and for an additional 72 days after the last

dose of study treatment.

- Female participants who are breastfeeding or who plan to breastfeed while on study

through 72 days after the last dose of study treatment.

- Female participants planning to become pregnant or donate eggs while on study through

72 days after the last dose of study treatment.

- 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 and for an additional 132 days after the last dose of

study treatment.

- Male participants with a pregnant partner who are unwilling to practice abstinence or

use a condom during treatment and for an additional 132 days after the last dose of

study treatment.

- Male participants unwilling to abstain from donating sperm during treatment and for an

additional 132 days after the last dose of study treatment.

- Participant has known sensitivity 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 (eg, Clinical

Outcome Assessments) to the best of the participant and investigator's knowledge.

- History or evidence of any other clinically significant disorder, condition, or

disease (with the exception of those outlined above) that, in the opinion of the

investigator or Amgen physician, if consulted, would pose a risk to participant safety

or interfere with the study evaluation, procedures or completion.

Studien-Rationale

Primary outcome:

1. PFS as Determined by Blinded Independent Central Review (BICR) (Time Frame - Up to approximately 6 years)

Secondary outcome:

1. Overall Survival (OS) Over the Whole Trial (Time Frame - Up to approximately 6 years)

2. PFS Determined by Investigator Assessment (Time Frame - Up to approximately 6 years)

3. Objective Response (OR) Rate (Time Frame - Up to approximately 6 years)

4. Disease Control (DC) Rate (Time Frame - Up to approximately 6 years)

5. Duration of Response (DOR) (Time Frame - Up to approximately 6 years)

6. PFS at 6 months, 1 year, 2 years (Time Frame - 6 months, 1 year, 2 years)

7. OS at 6 months, 1 year, 2 years, 3 years (Time Frame - 6 months, 1 year, 2 years, 3 years)

8. Time to Progression (TTP) (Time Frame - Up to approximately 6 years)

9. Number of Participants with Treatment-emergent Adverse Events (TEAEs) (Time Frame - Up to approximately 6 years)

10. Serum Concentration of Tarlatamab (Time Frame - Up to approximately 4 months)

11. Incidence of Anti-tarlatamab Antibody Formation (Time Frame - Up to approximately 1 year)

Studien-Arme

Experimental: Tarlatamab
Participants will receive tarlatamab on Cycle 1 Day 1, 8 and 15, and once every 2 weeks (Q2W) thereafter (cycle is 28 days).
Placebo Comparator: Placebo
Participants will receive placebo on Cycle 1 Day 1, 8 and 15, and Q2W thereafter (cycle is 28 days).

Geprüfte Regime

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

Quelle: ClinicalTrials.gov

Sie können folgenden Inhalt einem Kollegen empfehlen:

"Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!