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Risvutatug rezetecan vs topotecan for relapsed extensive-stage small cell lung cancer

Phase 3, Multicenter, Randomized, Open-label Clinical Study of GSK5764227, a B7-H3 Antibody Drug Conjugate (ADC), Compared With Topotecan in Participants With Relapsed Small Cell Lung Cancer (SCLC)

Phase 3 Interventional GlaxoSmithKline · NCT07099898

This trial tests whether Ris-Rez helps adults with relapsed extensive-stage small cell lung cancer shrink tumors and live longer compared with standard topotecan.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment420 (estimated)
Ages18 Years and up
SexAll
SponsorGlaxoSmithKline Industry-sponsored
Drugs / interventionstarlatamab, chemotherapy
Locations114 sites (Mar del Plata, Buenos Aires and 113 other locations)
Trial IDNCT07099898 on ClinicalTrials.gov

What this trial studies

This randomized Phase 3 trial enrolls adults with relapsed extensive-stage SCLC who previously received a platinum-based regimen plus a PD-(L)1 inhibitor and have measurable disease per RECIST 1.1. Participants are randomly assigned to receive Risvutatug rezetecan (a B7-H3–targeting agent) or the standard chemotherapy topotecan, with regular imaging and clinical visits to monitor tumor response and side effects. Primary outcomes include tumor response rates and overall survival, with secondary assessments of safety and tolerability. Key eligibility requirements include ECOG 0–1 and adequate organ function.

Who should consider this trial

Good fit: Adults with relapsed extensive-stage SCLC who progressed after one prior platinum-based therapy plus a PD-(L)1 inhibitor, have at least one measurable lesion, ECOG 0–1, and adequate organ function are the intended candidates.

Not a fit: Patients with poor performance status (ECOG ≥2), inadequate organ function, or those who have not received the required prior platinum plus PD-(L)1 therapy are unlikely to benefit from or qualify for this study.

Why it matters

Potential benefit: If successful, Ris-Rez could offer a more effective and better-tolerated option than topotecan for people with relapsed ES-SCLC, potentially improving tumor control and survival.

How similar studies have performed: B7-H3–directed therapies have shown promising signals in early-phase trials across several solid tumors but randomized Phase 3 data in SCLC are limited, making this a relatively novel approach in this disease.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Mar del Plata, Buenos Aires and 113 other locations

+64 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Neoplasms, LungSmall Cell Lung CancerRisvutatug RezetecanTopotecanEMBOLD SCLC-301Ris-Rez
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.