BridgeMD
Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer (DeLLphi-304)
EU CTIS ID: 2022-502669-14-00
What this study is testing
To compare the efficacy of tarlatamab with standard of care (SOC) 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 adult age within country, whichever is older) at the time of signing the informed consent.
- Histologically or cytologically confirmed relapsed/refractory SCLC with demostrated progression or relapse
- Subject has progressed or recurred following 1 platinum-based regimen.
- Measurable disease as defined per RECIST 1.1 within the 21-day screening period.
- Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
You likely can't join if
- symptomatic central nervous system (CNS) metastases or leptomeningeal disease.
- Active autoimmune disease that has required systemic treatment within the past 2 years or any other diseases requiring immunosuppressive therapy.
- Presence or history of viral infected as defined in protocol
- History of solid organ transplantation.
- History of other malignancy within the past 2 years
- Myocardial infarction and/or symptomatic congestive heart failure and arterial thrombosis within 12 months prior to first dose of study treatment.
See the full eligibility criteria
- Subject has provided informed consent prior to initiation of any study specific activities/procedures.
- Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.
- Histologically or cytologically confirmed relapsed/refractory SCLC with demostrated progression or relapse
- Subject has progressed or recurred following 1 platinum-based regimen.
- Measurable disease as defined per RECIST 1.1 within the 21-day screening period.
- Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
- Minimum life expectancy of 12 weeks.
- Adequate organ function.
- symptomatic central nervous system (CNS) metastases or leptomeningeal disease.
- Active autoimmune disease that has required systemic treatment within the past 2 years or any other diseases requiring immunosuppressive therapy.
- Presence or history of viral infected as defined in protocol
- History of solid organ transplantation.
- History of other malignancy within the past 2 years
- Myocardial infarction and/or symptomatic congestive heart failure and arterial thrombosis within 12 months prior to first dose of study treatment.
- Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to first dose of IP.
- 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
- Any previous diagnosis of NSCLC, or mixed SCLC NSCLC histology
- 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
- Subject has known sensitivity or is contraindicated to any of the products or components to be administered during dosing
- Evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Prior anti-cancer therapy within 21 days prior to first dose of IP.
- Current anti-cancer therapy such as chemotherapy, immunotherapy, or targeted therapy with exceptions
- 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.
- Subjects who have reached the limit dose of prior treatment with cardiotoxic drugs
- Live and live-attenuated vaccines within 14 days prior to the start of study treatment
- Prior history of immune checkpoint inhibitors resulting in protocol defined events
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Mexico
- United Kingdom
- China
- Australia
- Israel
- Switzerland
- Malaysia
- Canada
- Argentina
- Taiwan
- Korea, Republic of
- Turkey
- Japan
- Singapore
- Brazil
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Mexico; United Kingdom; China; Australia; Israel and 10 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.