A Study to Test How Well ZL-1310 may Work Compared to Therapies Selected by the Investigator in Treating Patients with Relapsed Small Cell Lung Cancer
Key facts
- Where
- Badajoz, Badalona, Barcelona, Elche, Girona, Jerez de la Frontera, Lleida, Madrid, Majadahonda, Málaga, Oviedo, Pamplona, Reus, Sevilla, Torrejón de Ardoz és Valencia, SpanyolországSee the 26 sites
- Phase
- 3. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
- Has your cancer come back or got worse during or after treatment with platinum chemotherapy?
- Has your cancer spread to the brain?
Where in Spanyolország
- Hospital Universitario de BadajozBadajoz, SpanyolországTaking people
- Institut Catala d'OncologiaBadalona, SpanyolországTaking people
- Hospital Clinic de BarcelonaBarcelona, SpanyolországTaking people
- Hospital de la Santa Creu i Sant PauBarcelona, SpanyolországTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországTaking people
- Micancer Center S.L.P.Barcelona, SpanyolországTaking people
- Hospital General Universitario de ElcheElche, SpanyolországTaking people
- Institut Català d'OncologiaGirona, SpanyolországTaking people
- Hospital de Jerez de la FronteraJerez de la Frontera, SpanyolországTaking people
- Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De LleidaLleida, SpanyolországTaking people
- Clinica Universidad de NavarraMadrid, SpanyolországTaking people
- Hospital Universitario La PazMadrid, SpanyolországTaking people
- Hospital Universitario Ramón y CajalMadrid, SpanyolországTaking people
- MD Anderson Cancer CenterMadrid, SpanyolországTaking people
- Hospital Universitario Puerta de Hierro de MajadahondaMajadahonda, SpanyolországTaking people
- Hospital Quironsalud MalagaMálaga, SpanyolországTaking people
- Hospital Universitario Central De AsturiasOviedo, SpanyolországTaking people
- Clínica Universidad de navarraPamplona, SpanyolországTaking people
- Salut Sant Joan de ReusReus, SpanyolországTaking people
- Hospital Universitario Virgen De La MacarenaSevilla, SpanyolországTaking people
- Hospital Universitario Virgen De ValmeSevilla, SpanyolországTaking people
- University Hospital Virgen Del Rocio S.L.Sevilla, SpanyolországTaking people
- Hospital Universitario de TorrejonTorrejón de Ardoz, SpanyolországTaking people
- Consorcio Hospital General Universitario de ValenciaValencia, SpanyolországTaking people
- Fundación Instituto Valenciano de OncologíaValencia, SpanyolországTaking people
- Hospital Universitario Y Politecnico La FeValencia, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zai Lab (US) LLC
- Trial code
- EU 2025-522818-23-00
- Record updated
- 2026. október 19.
- Original description
• To compare the anti-tumor activity between ZL 1310 and ICT • To compare ZL-1310 to ICT in prolonging overall survivalRead full original descriptionShow less
A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody Drug Conjugate (ADC), Compared to Investigator’s Choice Therapy in Participants with Relapsed Small Cell Lung Cancer
• To compare the anti-tumor activity between ZL 1310 and ICT • To compare ZL-1310 to ICT in prolonging overall survival
Inclusion: Histologically or cytologically confirmed SCLC. Mixed histology and/or transformed SCLC from non-small cell lung cancer are not allowed; Received 1L platinum-based systemic therapy and had documented disease progression during or after the most recent systemic therapy. Prior lines of systemic therapies are defined as follows: − Prior 1L therapy should be platinum-based chemotherapy in combination with an anti-PD-(L)1 agent. o Exception: combination with an anti-PD-(L)1 agent is not required in cases where the participant is considered to be ineligible to receive an anti-PD-(L)1 agent. o Maintenance therapy with an anti-PD-(L)1 agent and/or lurbinectedin and/or tarlatamab does not count as a separate line of therapy. o Platinum-based systemic therapy for limited-stage SCLC is considered 1L systemic therapy if disease progression occurs within 6 months of completion of platinum-based chemotherapy. − 2L systemic therapy is not allowed, except for tarlatamab; Measurable disease according to RECIST v1.1; Participants with a history of treated and stable CNS metastases are eligible; Participants with untreated and asymptomatic CNS metastases must not require steroids and/or anti-convulsants, nor local therapy as determined by the investigator per local guidelines; Eastern Cooperative Oncology Group performance status of 0 or 1; Life expectancy of at least 3 months; Adequate organ and marrow function; Must be willing to undergo a tumor biopsy or must provide archived tumor tissue sample at Screening.
Exclusion: Received more than one line of systemic therapy, other than tarlatamab, for SCLC; Received any prior ADC with a topoisomerase I inhibitor payload; Clinically severe pulmonary compromise (including but not limited to baseline oxygen saturation of <90% on room air) resulting from intercurrent pulmonary illnesses including but not limited to any underlying pulmonary disorder and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders. Participants who have prior pneumonectomy resulting in severe pulmonary compromise or who require continuous supplemental oxygen; Received radiotherapy within 2 weeks to non-thoracic area or within 4 weeks to the thoracic area prior to the first dose of study treatment or received >30 Gy of thoracic radiotherapy; History of (non-infectious) ILD/pneumonitis that required corticosteroids, current ILD/pneumonitis of any grade, or suspected ILD/pneumonitis that cannot be ruled out by imaging at Screening.