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

  • STATUS
    Recruiting
  • End date
    Aug 15, 2024
  • participants needed
    160
  • sponsor
    Amgen
Updated on 16 May 2022

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

Details
Condition Relapsed/Refractory Small Cell Lung Cancer
Treatment AMG 757, Tarlatamab
Clinical Study IdentifierNCT05060016
SponsorAmgen
Last Modified on16 May 2022

Eligibility

Yes No Not Sure

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 unless agreed upon with medical monitor and meeting the following criterion: 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 participants)
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
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