Neoplasms, Lung study: Risvutatug rezetecan vs Topotecan
Official title A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC) [EMBOLD SCLC-301]
ClinicalTrials.gov ID: NCT07099898
What this study is testing
What is Risvutatug rezetecan (Ris-Rez)?
An investigational biological medicine being studied for relapsed 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 compares how well Ris-Rez shrinks or eliminates cancer and whether it helps patients live longer than the standard drug topotecan. It also looks at how safe each drug is and what side effects they cause.
- Who it's for
- Adults whose small cell lung cancer has returned after previous treatment.
- What's involved
- Participants are randomly assigned to receive either Ris-Rez or topotecan. They will have regular visits for drug administration, medical exams, and tests to monitor cancer size and side effects.
- Time commitment
- The study lasts several months, with multiple clinic visits for treatment, monitoring, and follow‑up assessments.
- Phase 3: a large, late-stage study
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
- Adults \>18 or the minimum legal adult age at the time the informed consent form is signed
- Has histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
- Has received 1 prior platinum-based systemic therapy with a PD- (L)1 inhibitor for at least 2 cycles of therapy and a chemotherapy free-interval of...
- Has at least 1 target lesion per RECIST 1.1, as determined by the investigator.
- Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in the protocol.
You likely can't join if
- Pathological diagnosis of complex SCLC or transformed SCLC.
- Limited stage small cell lung cancer at diagnosis
- Has received any prior therapy with an Antibody-drug conjugate (ADC) with a Topoisomerase-1 (TOPO1)-inhibitor payload or treatments targeting B7-H3.
- Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor...
- Has severe, uncontrolled or active cardiovascular disorders.
- Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose.
See the full eligibility criteria
- Adults \>18 or the minimum legal adult age at the time the informed consent form is signed
- Has histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
- Has received 1 prior platinum-based systemic therapy with a PD- (L)1 inhibitor for at least 2 cycles of therapy and a chemotherapy free-interval of \>30 days, with documented progression.
- Has at least 1 target lesion per RECIST 1.1, as determined by the investigator.
- Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in the protocol.
- Has adequate organ function and an ECOG performance status of 0 or 1
- Pathological diagnosis of complex SCLC or transformed SCLC.
- Limited stage small cell lung cancer at diagnosis
- Has received any prior therapy with an Antibody-drug conjugate (ADC) with a Topoisomerase-1 (TOPO1)-inhibitor payload or treatments targeting B7-H3.
- Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
- Has severe, uncontrolled or active cardiovascular disorders.
- Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose.
- Known active infectious diseases requiring systemic treatment or known Human immunodeficiency virus (HIV).
- Has symptomatic brain metastases or untreated progression exclusively due to brain metastasis during or after the last treatment prior to screening, evidence of leptomeningeal/meningeal/brainstem metastasis or evidence...
- Has any evidence of current interstitial lung disease or pneumonitis or a prior history of ILD or non-infectious pneumonitis requiring high dose steroids.
- Has significant pulmonary disease or respiratory impairment (e.g., uncontrolled asthma/COPD, restrictive lung disease),
- Has active Hepatitis B or Hepatitis C
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Hialeah, Florida, United States
- Miami, Florida, United States
- Plantation, Florida, United States
- Tamarac, Florida, United States
- Hinsdale, Illinois, United States
- East Syracuse, New York, United States
- Wilson, North Carolina, United States
- Canton, Ohio, United States
- Fort Worth, Texas, United States
- Mar del Plata, Buenos Aires, Argentina
- Buenos Aires, Argentina
- Ciudad Autonoma de Buenos Aire, Argentina
- Rosario, Argentina
- Vicente López, Argentina
- Blacktown, New South Wales, Australia
- St Leonards, New South Wales, Australia
- Melbourne, Victoria, Australia
- Florianópolis, Santa Catarina, Brazil
- Barretos, Brazil
+ 105 more site(s).
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 Los Angeles, California, United States; Hialeah, Florida, United States; Miami, Florida, United States; Plantation, Florida, United States; Tamarac, Florida, United States; Hinsdale, Illinois, United States and 119 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.