No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
420 (estimated)
Sponsor
GlaxoSmithKline · Industry
Who this trial is looking for
This trial is looking for adults with relapsed small cell lung cancer. Participants will either receive a new medicine called Risvutatug rezetecan or the standard treatment, topotecan, to see which is more effective and safer.
Are You a Good Fit for This Trial?
You may be able to join if
I am an adult over 18 years old.
I have extensive-stage small cell lung cancer.
I have received 1 prior platinum-based therapy with a PD-1 or PD-L1 inhibitor.
I have at least 1 tumor that can be measured.
I can provide signed consent.
I have adequate organ function.
I have an ECOG performance status of 0 or 1.
You may not be able to join if
I have complex small cell lung cancer or transformed small cell lung cancer.
I had limited stage small cell lung cancer at diagnosis.
I have received treatment with an antibody-drug conjugate targeting B7-H3.
I have severe, uncontrolled cardiovascular disorders.
I have had significant bleeding symptoms in the past month.
I have an active infectious disease requiring treatment.
I have untreated brain metastases or spinal cord metastases.
I have significant lung disease or respiratory issues.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 dis…
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.
Trial Locations
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Eligibility 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…
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
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