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New treatment option for Neoplasms, Lung
Official title A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC)
ClinicalTrials.gov ID: NCT07099898
What this study is testing
What is Ris-Rez?
Ris-Rez is an investigational medicine, being studied as a potential treatment for neoplasms, lung.
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
- In this study researchers are testing Risvutatug rezetecan also known as (Ris-Rez) a new medicine that targets specific proteins (B7-H3) on cancer cells, thereby reducing the cancer's ability to grow and spread. This study specifically aims to evaluate how well Ris-Rez works in treating relapsed SCLC compared to standard treatment topotecan, by checking whether Ris-Rez makes cancers smaller or disappear completely and if it helps participants live longer.
- 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
- Participants are eligible to be included in the study only if all of the following criteria apply:
- 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.
You likely can't join if
- Participants are excluded from the study if any of the following criteria apply:
- 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.
See the full eligibility criteria
- Participants are eligible to be included in the study only if all of the following criteria apply:
- 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. Participants with prior...
- 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
- Participants are excluded from the study if any of the following criteria apply:
- 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's taking place
- 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
- Nedlands, Western Australia, Australia
- Barretos, Brazil
- CuritibaPR, Brazil
- Florianópolis, Brazil
- Porto Alegre, Brazil
- Rio de Janeiro, Brazil
- São Paulo, Brazil
- Pleven, Bulgaria
- Plovdiv, Bulgaria
- Rousse, Bulgaria
- Sofia, Bulgaria
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
+ 80 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 - 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?
Study sites include 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 and 94 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 ClinicalTrials.gov; the study team decides eligibility.