Clinical trial for Small Cell Lung Cancer (SCLC)
Official title A Study of Peluntamig (PT217) in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study)
ClinicalTrials.gov ID: NCT05652686
What this study is testing
What is Peluntamig (PT217)?
Peluntamig (PT217) is an investigational bispecific antibody being studied as a potential treatment for small cell lung cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out how safe and tolerable Peluntamig is, how it behaves in the body, and whether it shows any early signs of effectiveness, both alone and with chemotherapy.
- Who it's for
- It looks for adults who have small cell lung cancer, large cell neuroendocrine cancer, neuroendocrine prostate cancer, gastroenteropancreatic neuroendocrine cancer, or other neuroendocrine cancers that express DLL3.
- What's involved
- Participants will receive Peluntamig at different doses, sometimes together with chemotherapy, and will have regular visits for safety checks, blood tests, and other monitoring.
- Time commitment
- The study lasts several months, with multiple clinic visits for dosing, monitoring, and follow‑up assessments.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Key 1. 18 years or older and able to sign informed consent and comply with the protocol.
- Measurable disease as defined by RECIST v1.1 criteria for solid tumors.
- Substudy C1: patients with LCNEC or EP-NEC eligible for first-line (1L) CE treatment.
- Substudy C2: patients with SCLC, LCNEC and EP-NEC eligible for second line (2L) paclitaxel treatment.
- Substudies C3 and C5: patients with SCLC eligible for 2L or 3L treatment with lurbinectedin (C3) or topotecan (C5) are eligible.
You likely can't join if
- Women who are pregnant or lactating.
- Women of child-bearing potential (WOCBP) who do not use adequate birth control.
- Autoimmune disease requiring systemic treatment within the past twelve months. Additional inclusion and exclusions criteria will apply.
See the full eligibility criteria
- Key 1. 18 years or older and able to sign informed consent and comply with the protocol.
- Measurable disease as defined by RECIST v1.1 criteria for solid tumors.
- Substudy C1: patients with LCNEC or EP-NEC eligible for first-line (1L) CE treatment. SCLC patients who have relapsed on a 1L treatment (including platinum-based therapy with or without ICI) but remain platinum...
- Substudy C2: patients with SCLC, LCNEC and EP-NEC eligible for second line (2L) paclitaxel treatment.
- Substudies C3 and C5: patients with SCLC eligible for 2L or 3L treatment with lurbinectedin (C3) or topotecan (C5) are eligible.
- Substudy D1: will include 2L patients with SCLC, LCNEC, pr EP-NEC (excluding GEP-NEC) that have progressed/relapsed from their first-line treatment that may have included an ICI.
- Substudy D2: will include 1L ES-SCLC patients that have completed their induction therapy with carboplatin and etoposide plus atezolizumab and are eligible to continue with atezolizumab.
- Substudy D3: will include 1L ES-SCLC patients that are treatment naïve or have received C1D1/2/3 and are eligible for treatment with CE plus atezolizumab.
- Able to provide a formalin fixed, paraffin embedded (FFPE) tumor tissue sample (preferably a newly acquired biopsy, or if not possible, archival tissue) to be assessed for DLL3 expression and other biomarkers.
- ECOG performance status of 0 or 1.
- Adequate organ function confirmed at screening and within 72 hours of initiating C1D1 of Peluntamig (PT217) treatment. Key
- Women who are pregnant or lactating.
- Women of child-bearing potential (WOCBP) who do not use adequate birth control.
- Autoimmune disease requiring systemic treatment within the past twelve months. Additional inclusion and exclusions criteria will apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Duarte, California, United States
- Los Angeles, California, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Chapel Hill, North Carolina, United States
- Durham, North Carolina, United States
- Oklahoma City, Oklahoma, United States
- Portland, Oregon, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
- Seattle, Washington, United States
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, but 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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Duarte, California, United States; Los Angeles, California, United States; Denver, Colorado, United States; New Haven, Connecticut, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States and 8 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.