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Study Evaluating Tarlatamab After Chemoradiotherapy in Limited‑Stage Small‑Cell Lung Cancer (DeLLphi-306)
EU CTIS ID: 2023-506235-15-00
What this study is testing
Compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS) based on blinded independent central review (BICR) per RECIST 1.1 Compare the efficacy of tarlatamab with placebo on prolonging overall survival (OS)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject 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 SCLC.
- Diagnosed and treated for LS-SCLC with concurrent chemotherapy and radiotherapy
- Has completed chemoradiotherapy without progression per RECIST 1.1. (ie, achieved CR, PR, or SD).
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
You likely can't join if
- Extensive-stage SCLC
- Female subjects of childbearing potential unwilling to use protocol specified method of contraception see protocol Appendix 5 (Section 11.5) during treatment and for an additional 60 days after the last dose of study treatment.
- Female subjects who are breastfeeding or to become pregnant who plan to breastfeed or while on study through 60 days after the last dose of study treatment.
- 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.
- Female subjects planning to become pregnant or donate eggs while on study through 60 days after the last dose of study treatment.
- Male subjects with a female partner of childbearing potential or a pregnant partner who are unwilling to practice sexual abstinence or use contraception during treatment and for an additional 60 days after the last dose of study treatment
See the full eligibility criteria
Who can join
- Subject 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 SCLC.
- Diagnosed and treated for LS-SCLC with concurrent chemotherapy and radiotherapy
- Has completed chemoradiotherapy without progression per RECIST 1.1. (ie, achieved CR, PR, or 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.
What rules you out
- Extensive-stage SCLC
- Female subjects of childbearing potential unwilling to use protocol specified method of contraception see protocol Appendix 5 (Section 11.5) during treatment and for an additional 60 days after the last dose of study treatment.
- Female subjects who are breastfeeding or to become pregnant who plan to breastfeed or while on study through 60 days after the last dose of study treatment.
- 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.
- Female subjects planning to become pregnant or donate eggs while on study through 60 days after the last dose of study treatment.
- Male subjects with a female partner of childbearing potential or a pregnant partner who are unwilling to practice sexual abstinence or use contraception during treatment and for an additional 60 days after the last dose of study treatment
- Male subjects unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of study treatment.
- Subject has known sensitivity to any of the products or components to be administered during dosing.
- Subject likely to not be available to complete all protocol-required study visits or procedures
- History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- Evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Received sequential chemotherapy and thoracic radiotherapy during chemoradiation.
- History of other malignancy within the past 2 years. Refer to protocol section 5.2 for more details.
- History of solid organ transplantation.
- Myocardial infarction and/or symptomatic congestive heart failure within 6 months prior to first dose of study treatment.
- History of arterial thrombosis within 6 months prior to first dose of study treatment.
- Presence of active Human immunodeficiency virus (HIV) or active hepatitis infection. Refer to protocol section 8.4.5.5 for more details.
- Subject 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.
- Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of study treatment
- Prior therapy with any selective inhibitor of the DLL3 pathway.
- Prior history of severe or life-threatening events from any immunemediated 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.
- Treatment in an alternative investigational trial within 28 days prior to enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- Singapore
- Taiwan
- Colombia
- United Kingdom
- China
- Japan
- Hong Kong
- Korea, Democratic People's Republic of
- United States
- Turkey
- Switzerland
- Brazil
- Australia
- Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; Singapore; Taiwan; Colombia; United Kingdom; China and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.