Small Cell Lung Cancer
Conditions
Interventions
Ris-Rez will be administered
Topotecan will be administered
Sponsors
Ishibashi Hideyasu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.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
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| -Objective Response Rate (ORR) -Duration of Response (DoR) -Progression-free survival (PFS) -Disease control rate (DCR) 12 -Brain PFS -Brain DoR -Brain ORR -Brain DCR12 -Time to brain progression -Number of participants with Adverse events (AEs), Serious Adverse Events (SAEs) and Adverse events of special interest (AESIs) by severity -Number of participants with AEs leading to dose modifications or study intervention discontinuation -Change from baseline in vital signs, laboratory parameters, cardiac function (ECG) and ECOG performance status -Observed PK concentrations of Ris-Rez -Number of participants with Antidrug antibody (ADA) or Neutralizing Antibody (NAb) -Titers of ADA against Ris-Rez -Participant reported experience with study treatment (PRO) | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Mexico, Poland, Portugal, Romania, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States
Contacts
Public ContactHideyasu Ishibashi
GlaxoSmithKline K.K.
Outcome results
None listed