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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
EU CTIS ID: 2025-522818-23-00
What this study is testing
To compare the anti-tumor activity between ZL 1310 and ICT To compare ZL-1310 to ICT in prolonging overall survival
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Histologically or cytologically confirmed SCLC. Mixed histology and/or transformed SCLC from non-small cell lung cancer are not allowed.
- 2. 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.
- 3. Measurable disease according to RECIST v1.1.
- 4. Participants with a history of treated and stable CNS metastases are eligible.
- 5. 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.
- 6. Eastern Cooperative Oncology Group performance status of 0 or 1.
You likely can't join if
- 1. Received more than one line of systemic therapy, other than tarlatamab, for SCLC.
- 2. Received any prior ADC with a topoisomerase I inhibitor payload.
- 3. 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.
- 4. 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.
- 5. 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.
See the full eligibility criteria
Who can join
- 1. Histologically or cytologically confirmed SCLC. Mixed histology and/or transformed SCLC from non-small cell lung cancer are not allowed.
- 2. 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.
- 3. Measurable disease according to RECIST v1.1.
- 4. Participants with a history of treated and stable CNS metastases are eligible.
- 5. 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.
- 6. Eastern Cooperative Oncology Group performance status of 0 or 1.
- 7. Life expectancy of at least 3 months.
- 8. Adequate organ and marrow function.
- 9. Must be willing to undergo a tumor biopsy or must provide archived tumor tissue sample at Screening.
What rules you out
- 1. Received more than one line of systemic therapy, other than tarlatamab, for SCLC.
- 2. Received any prior ADC with a topoisomerase I inhibitor payload.
- 3. 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.
- 4. 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.
- 5. 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.
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- United States
- United Kingdom
- Korea, Republic of
- Japan
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey; United States; United Kingdom; Korea, Republic of; Japan; China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.