RecruitingNCT07099898ClinicalTrials.gov record

A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC) [EMBOLD SCLC-301]

Neoplasms, Lung

Ask WCR about this study Official registry record ↗

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Phase 3
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 420 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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. The study is also assessing whether Ris-Rez is safe and tolerated well by participants compared to topotecan and provide a better understanding of the main side effects of both drugs. Participants with relapsed SCLC will be randomly divided into two groups: one group receiving Ris-Rez and the other receiving topotecan.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion 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 tarlatamab treatment in either the first- or second-line ES-SCLC setting are eligible.
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

Exclusion Criteria:

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 of spinal cord metastases.
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

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: No masking

Risvutatug rezetecan (Ris-Rez)

Not reported in this registry record.

Biological: Risvutatug rezetecan (Ris-Rez)

Topotecan

Not reported in this registry record.

Drug: Topotecan

Risvutatug rezetecan (Ris-Rez) BIOLOGICAL

Ris-Rez will be administered

Topotecan DRUG

Topotecan will be administered

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Overall Survival (OS)

Time frame: Up to approximately 113 weeks

OS is defined as the time from the date of randomization to the date of death by any cause

Secondary measures

Brain PFS

Time frame: Up to approximately 139 weeks

Brain PFS is defined as the time from the date of randomization to the date of first documented PD per modified Response assessment in neuro-oncology (RANO-BM) by BICR assessment or death from any cause, whichever occurs first in participants with history of brain metastasis or presence of brain metastasis at baseline

Change from baseline in cough

Time frame: Up to approximately 18 weeks

Validated questionnaires will be used for the assessment

Change from baseline in dyspnea

Time frame: Up to approximately 18 weeks

Validated questionnaires will be used for the assessment

Change from baseline in chest pain

Time frame: Up to approximately 18 weeks

Validated questionnaires will be used for the assessment

Time to clinical deterioration in physical functioning

Time frame: Up to approximately 139 weeks

Time to clinical deterioration in physical functioning will be measured using validated questionnaires

Objective Response Rate (ORR)

Time frame: Up to approximately 139 weeks

ORR is defined as the percentage of participants with a confirmed complete (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator/Blinded Independent Central Review (BICR) assessment

Duration of Response (DoR)

Time frame: Up to approximately 139 weeks

DoR is defined as the time from the date of first documented objective response (CR or PR) per RECIST 1.1 by investigator/BICR assessment to the date of first documented PD per RECIST 1.1 by investigator/BICR assessment or death due to any cause, whichever comes first

Progression-free survival (PFS)

Time frame: Up to approximately 139 weeks

PFS is defined as the time from the date of randomization to the date of first documented Progressive disease (PD) per RECIST 1.1 by investigator/BICR assessment or death from any cause, whichever occurs first

Disease control rate (DCR) 12

Time frame: Up to approximately 11 weeks

DCR12 is defined as the percentage of participants who have a Best objective response (BOR) of confirmed CR, confirmed PR, or Stable Disease (SD) for a duration of at least 11 weeks, per RECIST 1.1 by investigator/BICR assessment

Brain DoR

Time frame: Up to approximately 139 weeks

Brain DoR is defined as the time from the first documented objective response (CR/PR according to modified RANO-BM BICR assessment) until the time of first documentation of disease progression or death, whichever occurs first, in participants with a history of brain metastasis or presence of brain metastasis at baseline

Brain ORR

Time frame: Up to approximately 139 weeks

Brain ORR is defined as the percentage of participants with confirmed brain CR or confirmed brain PR per modified RANO-BM BICR assessment in participants with a history of brain metastasis or presence of brain metastasis at baseline

Brain DCR12

Time frame: Up to approximately 11 weeks

Brain DCR12 is defined as the percentage of participants with an intracranial BOR of confirmed CR, confirmed PR or SD after the date of randomization, per modified RANO-BM BICR assessment in participants with a history of brain metastasis or presence of brain metastasis at baseline

Time to brain progression

Time frame: Up to approximately 139 weeks

Time to brain progression is defined as the time from the date of randomization to the date of first documented brain PD per modified RANO-BM BICR assessment in participants with a history of brain metastasis or presence of brain metastasis at baseline.

Number of participants with Adverse events (AEs), Serious Adverse Events (SAEs) and Adverse events of special interest (AESIs) by severity

Time frame: Up to approximately 139 weeks

Not reported in this registry record.

Number of participants with AEs leading to dose modifications or study intervention discontinuation

Time frame: Up to approximately 139 weeks

Not reported in this registry record.

Number of participants with a change from baseline in vital signs

Time frame: Baseline (Day -1) and up to approximately 139 weeks

Number of participants will be assessed.

Number of participants with a change from baseline in laboratory parameters (hematology and clinical chemistry)

Time frame: Baseline (Day -1) and up to approximately 139 weeks

Number of participants will be assessed.

Number of participants with a change from baseline in cardiac function [Electrocardiogram (ECG)

Time frame: Baseline (Day -1) and up to approximately 139 weeks

Number of participants will be assessed.

Number of participants with a change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status

Time frame: Baseline (Day -1) and up to approximately 139 weeks

Number of participants will be assessed.

Observed PK concentrations of Ris-Rez (conjugated antibody and small molecule payload)

Time frame: Up to approximately 139 weeks

Not reported in this registry record.

Number of participants with Antidrug antibody (ADA) or Neutralizing Antibody (NAb)

Time frame: Up to approximately 139 weeks

Not reported in this registry record.

Titers of ADA against Ris-Rez

Time frame: Up to approximately 139 weeks

Not reported in this registry record.

Participant reported experience with study treatment

Time frame: Up to approximately 139 weeks

Participant reported outcomes assessing symptoms, daily functioning, and overall health status during study treatment will be measured using validated questionnaires

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (148)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

Find a location in this study

148 locations

GSK Investigational SiteLos Angeles, California, United StatesRecruiting

US GSK Clinical Trials Call CenterCONTACTGSKClinicalSupportHD@gsk.com 877-379-3718

EU GSK Clinical Trials Call CentreCONTACTGSKClinicalSupportHD@gsk.com +44 (0) 20 8990 4466

Ghassan Al-JazayrlyPRINCIPAL_INVESTIGATOR

What this study involves

About the research

Who may be able to participate?

Treatment, groups and participation

What researchers are measuring

Primary measures

Secondary measures

Research locations (148)

Study team and timeline

Official study contacts

Ask Wellness Clinical Research