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Taking peoplePhase 3

ZL-1310 Compared With Other Chosen Treatments for Small Cell Lung Cancer That Has Returned

Compares ZL-1310 with investigator-chosen therapy in adults with relapsed small cell lung cancer.

Key facts

Who runs it
Zai Lab (US) LLC
Where
Herlev and Vejle, DenmarkSee the 2 sitesAlso in 13 other countries, 137 sites
Registry title
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
Status
Recruiting
Phase
Phase 3
People taking part
263 people, planned
Started
26 Jun 2026
Expected to end
30 Nov 2028
Type of study
Interventional
Record updated
19 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with small cell lung cancer that came back or got worse after first treatment with platinum chemotherapy. It compares ZL-1310 with a therapy chosen by the doctor.

Age
18 years or older
Sex
All sexes can join
Disease stage
Small cell lung cancer confirmed by tissue or cell tests, with measurable disease. Treated and stable brain metastases are allowed. Untreated brain metastases with no symptoms are allowed if they need no steroids, anti-seizure drugs or local therapy.
Earlier treatment
Must have had first-line platinum-based chemotherapy, usually with an anti-PD-(L)1 drug, and the disease got worse during or after it. No second-line therapy, except tarlatamab. No earlier antibody drug conjugate with a topoisomerase I inhibitor payload.

Main reasons for not taking part

  • More than one line of systemic therapy, other than tarlatamab
  • Earlier antibody drug conjugate with a topoisomerase I inhibitor payload
  • History of lung inflammation (ILD/pneumonitis) needing corticosteroids, or current ILD/pneumonitis of any grade
  • Severe lung problems, such as oxygen saturation below 90% on room air or needing continuous oxygen
  • Radiotherapy within 2 weeks (non-chest area) or 4 weeks (chest area) before the first dose, or more than 30 Gy to the chest

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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 Denmark

Also in 13 other countries, 137 sites

  • Region HovedstadenHerlev, DenmarkNot yet recruiting
  • Lillebaelt HospitalVejle, DenmarkNot yet recruiting

About the trial

What the trial wants to find out

• To compare the anti-tumor activity between ZL 1310 and ICT • To compare ZL-1310 to ICT in prolonging overall survival

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
ZL-1310 Compared With Other Chosen Treatments for Small Cell Lung Cancer That Has ReturnedGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Fit questions
Built from 2025-522818-23-00, who can take part
Record updated
19 October 2026