Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer (DeLLphi-304)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amgen Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

18 Dec 2023 → ongoing

Decision date (initial)

2023-07-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Amgen Inc

External identifiers

EU CT number

2022-502669-14-00

WHO UTN

U1111-1286-5138

ClinicalTrials.gov

NCT05740566

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Dose response, Pharmacokinetic, Others, Efficacy

To compare the efficacy of tarlatamab with standard of care (SOC) on prolonging overall survival (OS)

Secondary objectives 2

1. To compare the effect of tarlatamab with SOC as assessed by progression free survival (PFS) based on study doctor assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
2. To compare the treatment effect of tarlatamab with SOC on Patient-reported disease-related symptoms, Physical Function, and Quality of Life

Conditions and MedDRA coding

Small cell lung cancer (SCLC)

Study design 1 period

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Subject has provided informed consent prior to initiation of any study specific activities/procedures.
2. Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.
3. Histologically or cytologically confirmed relapsed/refractory SCLC with demostrated progression or relapse
4. Subject has progressed or recurred following 1 platinum-based regimen.
5. Measurable disease as defined per RECIST 1.1 within the 21-day screening period.
6. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
7. Minimum life expectancy of 12 weeks.
8. Adequate organ function.

Exclusion criteria 18

1. symptomatic central nervous system (CNS) metastases or leptomeningeal disease.
2. Subject has known sensitivity or is contraindicated to any of the products or components to be administered during dosing
3. Evidence of interstitial lung disease or active, non-infectious pneumonitis.
4. Prior anti-cancer therapy within 21 days prior to first dose of IP.
5. Current anti-cancer therapy such as chemotherapy, immunotherapy, or targeted therapy with exceptions
6. Use of herbal or medications known to be moderate or strong inhibitors of membrane transporters P-gp and/or BCRP or CYP3A enzymes within 7 days or strong inducers of CYP3A within 28 days prior to the first dose of IP.
7. Subjects who have reached the limit dose of prior treatment with cardiotoxic drugs
8. Live and live-attenuated vaccines within 14 days prior to the start of study treatment
9. Prior history of immune checkpoint inhibitors resulting in protocol defined events
10. Active autoimmune disease that has required systemic treatment within the past 2 years or any other diseases requiring immunosuppressive therapy.
11. Presence or history of viral infected as defined in protocol
12. History of solid organ transplantation.
13. History of other malignancy within the past 2 years
14. Myocardial infarction and/or symptomatic congestive heart failure and arterial thrombosis within 12 months prior to first dose of study treatment.
15. Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to first dose of IP.
16. 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
17. Any previous diagnosis of NSCLC, or mixed SCLC NSCLC histology
18. Male subjects with a female partner of childbearing potential or pregnant who are unwilling to practice sexual abstinence or use contraception or abstain from donating sperm or donate eggs during treatment

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Overall Survival is defined as the length of time from start of treatment (tarlatamab or Standard Of Care) for the disease until death, due to any cause

Secondary endpoints 2

1. The length of time the participants are grouped to receive either tarlatamab or Standard Of Care by chance until the disease has progressed or resulted in death
2. Change from Baseline PROs assessed 6-weekly over time to 18 weeks for Chest Pain, cough as measured by EORTC-QLQ-LC13; Tightening in the chest as measured by EORTC-QLQ-C30 and EORTC-QLQ-LC13; and Physical Function and Global Health Status of life as measured by EORTC-QLQ-C30

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 4

Auxiliary 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amgen Inc.

Sponsor organisation

Amgen Inc.

Address

1 Amgen Center Drive

City

Thousand Oaks

Postcode

91320-1799

Country

United States

Scientific contact point

Organisation

Amgen Inc.

Contact name

Medical Information

Public contact point

Organisation

Amgen Inc.

Contact name

Medical Information

Third parties 13

Locations

15 EU/EEA countries · 69 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 220 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

10 submissions — initial application plus substantial / non-substantial modifications