A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC) (DeLLphi-301)

Sponsor

Amgen (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05060016

Collaborator

(none)

160

Enrollment

Locations

Arms

35.9

Anticipated Duration (Months)

2.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main aim of this study is to:

evaluate safety and efficacy (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] by investigator) of 2 dose levels of Tarlatamab for Part 1 only
evaluate anti-tumor activity of Tarlatamab as determined by objective response rate (ORR) per RECIST 1.1 by blinded independent central review (BICR) for Part 1 and 2

Condition or Disease	Intervention/Treatment	Phase
Relapsed/Refractory Small Cell Lung Cancer	Drug: Tarlatamab	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Tarlatamab in Subjects With Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment

Actual Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Jun 28, 2023

Anticipated Study Completion Date :

Nov 29, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1: Tarlatamab Low Dose Participants will receive the low dose of Tarlatamab.	Drug: Tarlatamab Intravenous (IV) infusion
Experimental: Part 1: Tarlatamab High Dose Participants will receive the high dose of Tarlatamab.	Drug: Tarlatamab Intravenous (IV) infusion
Experimental: Part 2: Dose Expansion Participants will receive the selected target dose of Tarlatamab based on findings in Part 1.	Drug: Tarlatamab Intravenous (IV) infusion

Arm

Intervention/Treatment

Experimental: Part 1: Tarlatamab Low Dose

Participants will receive the low dose of Tarlatamab.

Drug: Tarlatamab

Intravenous (IV) infusion

Experimental: Part 1: Tarlatamab High Dose

Participants will receive the high dose of Tarlatamab.

Drug: Tarlatamab

Intravenous (IV) infusion

Experimental: Part 2: Dose Expansion

Participants will receive the selected target dose of Tarlatamab based on findings in Part 1.

Drug: Tarlatamab

Intravenous (IV) infusion

Outcome Measures

Primary Outcome Measures

Part 1 Only: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator [Up to a maximum of 24 months]
Part 1 Only: Number of Participants who Experience One or More Treatment-emergent Adverse Events [Up to a maximum of 24 months]
Part 1 Only: Serum Concentrations of Tarlatamab [Up to a maximum of 24 months]
Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR) [Up to a maximum of 24 months]

Secondary Outcome Measures

Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR) [Up to a maximum of 24 months]
Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR) [Up to a maximum of 24 months]
Duration of Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR) [Up to a maximum of 24 months]
Progression-free Survival (PFS) Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR) [Up to a maximum of 24 months]
Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator [Up to a maximum of 24 months]
Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator [Up to a maximum of 24 months]
Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator [Up to a maximum of 24 months]
Duration of Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator [Up to a maximum of 24 months]
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator [Up to a maximum of 24 months]
Overall Survival (OS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator [Up to a maximum of 24 months]
Number of Participants who Experience One or More Treatment-emergent Adverse Events [Up to a maximum of 24 months]
Serum Concentrations of Tarlatamab [Up to a maximum of 24 months]
Number of Participants who Experience Anti-Tarlatamab Antibody Formation [Up to a maximum of 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures.
Male and female participants ≥ 18 years of age (or legal adult age within country) at the time of signing the informed consent.
Histologically or cytologically confirmed relapsed/refractory SCLC
Participants who progressed or recurred following 1 platinum-based regimen and at least 1 other prior line of therapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0 1.
Minimum life expectancy of 12 weeks.
Measurable lesions as defined per RECIST 1.1 within 21 days prior to the first dose of tarlatamab.
Participants with treated brain metastases are eligible provided they meet defined criteria.

Exclusion Criteria:

Disease Related

Untreated or symptomatic brain metastases and leptomeningeal disease.
Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
Participants who experienced recurrent pneumonitis (grade 2 or higher) or severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
Unresolved toxicity from prior anti-tumor therapy, defined as per protocol.

Other Medical Conditions

History of other malignancy within the past 2 years, with exceptions
Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of tarlatamab.
History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of first dose of tarlatamab.
Presence of fungal, bacterial, viral, or other infection requiring oral or IV antimicrobials for management within 7 days of first dose of tarlatamab.
Presence of any indwelling line or drain.
History of hypophysitis or pituitary dysfunction.
Exclusion of hepatitis infection based on the results and/or criteria per protocol.
Major surgery within 28 days of first dose of tarlatamab.
History or evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Subject is eligible if no acute symptoms of coronavirus disease 2019 (COVID-19) within 14 days prior to first dose of tarlatamab (counted from day of positive test for asymptomatic subjects).

Prior/Concomitant Therapy

Participant received prior therapy with tarlatamab.
Prior anti-cancer therapy within 28 days prior to first dose of tarlatamab.
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 tarlatamab.
Live and live-attenuated vaccines within 4 weeks prior to the start off tarlatamab treatment.

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 tarlatamab.
Female participants who are breastfeeding or who plan to breastfeed while on study through 72 days after the last dose of tarlatamab.
Female participants planning to become pregnant while on study through 72 days after the last dose of tarlatamab.
Female participants of childbearing potential with a positive pregnancy test assessed at screening and/or day 1 by a highly sensitive urine or 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 tarlatamab.
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 tarlatamab.
Male participants unwilling to abstain from donating sperm during treatment and for an additional 132 days after the last dose of tarlatamab.
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.
History or evidence of any other clinically significant disorder, condition or disease determined by the investigator or Amgen physician.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35249
2	Henry Ford Health System	Detroit	Michigan	United States	48202
3	Dartmouth Hitchcock Medical Center	Hanover	New Hampshire	United States	03756
4	Wake Forest Baptist Comprehensive Cancer Research Center	Winston-Salem	North Carolina	United States	27157
5	Oncology Hematology Care Inc	Cincinnati	Ohio	United States	45242
6	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106
7	University of Pittsburgh Medical Center Cancer Pavillion	Pittsburgh	Pennsylvania	United States	15232
8	Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203
9	West Virginia University Health Sciences Center	Morgantown	West Virginia	United States	26506
10	Universitaetsklinikum Krems	Krems		Austria	3500
11	Landeskrankenhaus Salzburg	Salzburg		Austria	5020
12	Universitair Ziekenhuis Gent	Gent		Belgium	9000
13	Grand Hopital de Charleroi - Site Saint Joseph	Gilly		Belgium	6060
14	Universitair Ziekenhuis Leuven - Campus Gasthuisberg	Leuven		Belgium	3000
15	Rigshospitalet	Copenhagen		Denmark	2100
16	Centre Hospitalier Universitaire Nord	Marseille Cedex 20		France	13915
17	Institut Curie	Paris Cedex 05		France	75248
18	Centre Hospitalier Lyon Sud	Pierre-Benite cedex		France	69495
19	Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou	Rennes		France	35033
20	Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil	Strasbourg cedex		France	67091
21	Centre Hospitalier Universitaire de Toulouse - Hopital Larrey	Toulouse cedex 9		France	31059
22	Institut Gustave Roussy	Villejuif		France	94805
23	LungenClinic Grosshansdorf GmbH	Grosshansdorf		Germany	22927
24	Universitaetsklinikum Koeln	Köln		Germany	50937
25	Universitätsklinikum Würzburg	Würzburg		Germany	97078
26	Henry Dunant Hospital Center	Athens		Greece	11526
27	Sotiria General Hospital	Athens		Greece	11527
28	Metropolitan Hospital	Athens		Greece	18547
29	University Hospital of Heraklion	Heraklion - Crete		Greece	71110
30	General Hospital of Patras Agios Andreas	Patra		Greece	26335
31	Theagenion Cancer Hospital	Thessaloniki		Greece	54007
32	Euromedica General Clinic of Thessaloniki	Thessaloniki		Greece	54645
33	Agios Loukas Clinic	Thessaloniki		Greece	55236
34	Azienda Ospedaliero-Universitaria di Parma	Parma		Italy	43126
35	Istituti Fisioterapici Ospitalieri Regina Elena San Gallicano	Rome		Italy	00144
36	Aichi Cancer Center	Nagoya-shi	Aichi	Japan	464-8681
37	National Cancer Center Hospital East	Kashiwa-shi	Chiba	Japan	277-8577
38	Okayama University Hospital	Okayama-shi	Okayama	Japan	700-8558
39	Kindai University Hospital	Osakasayama-shi	Osaka	Japan	589-8511
40	Shizuoka Cancer Center	Sunto-gun	Shizuoka	Japan	411-8777
41	The Cancer Institute Hospital of Japanese Foundation for Cancer Research	Koto-ku	Tokyo	Japan	135-8550
42	Wakayama Medical University Hospital	Wakayama-shi	Wakayama	Japan	641-8510
43	National Cancer Center	Goyang-si Gyeonggi-do		Korea, Republic of	10408
44	Seoul National University Bundang Hospital	Seongnam-si, Gyeonggi-do		Korea, Republic of	13620
45	Yonsei University Health System Severance Hospital	Seoul		Korea, Republic of	03722
46	Asan Medical Center	Seoul		Korea, Republic of	05505
47	Samsung medical center	Seoul		Korea, Republic of	06351
48	The Catholic University of Korea Seoul St Marys Hospital	Seoul		Korea, Republic of	06591
49	Erasmus Medisch Centrum	Rotterdam		Netherlands	3015 GD
50	Uniwersyteckie Centrum Kliniczne	Gdansk		Poland	80-214
51	Centra Medyczne Medyceusz Sp zoo	Lodz		Poland	91-053
52	Mazowieckie Centrum Leczenia	Otwock		Poland	05-400
53	Hospital da Luz, SA	Lisboa		Portugal	1500-650
54	Hospital CUF Descobertas	Lisboa		Portugal	1998-018
55	Hospital Cuf porto	Porto		Portugal	4100-180
56	Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE	Porto		Portugal	4200-072
57	Hospital Regional Universitario de Malaga	Malaga	Andalucía	Spain	29011
58	Hospital Universitari Vall d Hebron	Barcelona	Cataluña	Spain	08035
59	Hospital Clinic i Provincial de Barcelona	Barcelona	Cataluña	Spain	08036
60	Hospital de la Santa Creu i Sant Pau	Barcelona	Cataluña	Spain	08041
61	Instituto Catalan de Oncologia Hospital Duran i Reynals	Hospitalet de Llobregat	Cataluña	Spain	08908
62	Hospital Universitari i Politecnic La Fe	Valencia	Comunidad Valenciana	Spain	46026
63	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda	Madrid	Spain	28222
64	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
65	Hopitaux Universitaires de Geneve	Geneve 14		Switzerland	1211
66	Taipei Veterans General Hospital	Taipei		Taiwan	11217
67	Christie Hospital	Manchester		United Kingdom	M20 4BX