480 Participants Needed

ZL-1310 for Lung Cancer

Recruiting at 4 trial locations
ZS
Overseen ByZL-1310-003 Study Team
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ZL-1310 for individuals with relapsed Small Cell Lung Cancer (SCLC). Researchers aim to determine if ZL-1310 is more effective and safer than other treatments chosen by doctors. The study consists of two parts: one group will receive ZL-1310, while the other will receive a treatment selected by their doctor. Candidates may qualify if they have SCLC that has progressed after previous treatments and are willing to provide a tumor sample. As a Phase 3 trial, this study is the final step before FDA approval, offering participants the chance to contribute to the potential availability of a new treatment option.

Is there any evidence suggesting that ZL-1310 is likely to be safe for humans?

Research has shown that ZL-1310 has been safe for participants in earlier studies. In past trials, participants experienced manageable side effects, indicating that most tolerated the treatment well. Importantly, ZL-1310 proved effective against tumors, including those in the brain. These results suggest that ZL-1310 could be a promising option for individuals with relapsed Small Cell Lung Cancer. While all treatments can have side effects, evidence so far indicates that ZL-1310 is relatively safe for humans.12345

Why do researchers think this study treatment might be promising for lung cancer?

ZL-1310 is unique because it potentially offers a new approach to treating lung cancer by acting as a single-agent therapy. Unlike most standard treatments that involve chemotherapy or targeted therapies, ZL-1310 could target cancer cells through a different mechanism, providing an alternative for patients who may not respond well to existing options. Researchers are excited about ZL-1310 because it could improve outcomes for patients with fewer side effects and offer a novel mechanism of action that might be more effective against certain types of lung cancer cells.

What evidence suggests that ZL-1310 might be an effective treatment for lung cancer?

Research has shown that ZL-1310 offers promising results for treating small cell lung cancer. In a study with 102 patients, almost half (47%) experienced a confirmed response, with tumors shrinking or disappearing. These effects lasted an average of 6.1 months. The treatment also effectively targeted brain tumors while maintaining manageable side effects. In this trial, participants will receive either ZL-1310 as a single agent or an investigator's choice of therapy. These findings suggest ZL-1310 could be a strong option for patients whose small cell lung cancer has returned.12346

Are You a Good Fit for This Trial?

This trial is for adults with relapsed Small Cell Lung Cancer who've had previous platinum-based therapy and progressed during or after treatment. They must have measurable disease, stable brain metastases if present, good organ function, an ECOG performance status of 0 or 1, and a life expectancy of at least three months.

Inclusion Criteria

I have signed the informed consent form.
My cancer can be measured by standard health scans.
My doctor expects me to live at least 3 more months.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ZL-1310 or Investigator's Choice Therapy

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ZL-1310

Trial Overview

The study compares the effectiveness and safety of ZL-1310 to treatments chosen by the investigators (standard options) in patients with relapsed Small Cell Lung Cancer. Participants will be randomly assigned to receive either ZL-1310 or a standard therapy.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1Experimental Treatment1 Intervention
Group II: Arm 2Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Zai Lab (Shanghai) Co., Ltd.

Lead Sponsor

Trials
30
Recruited
3,800+

Zai Lab (US) LLC

Industry Sponsor

Trials
3
Recruited
450+

Citations

Zai Lab Announces Updated Phase 1 Data for Zocilurtatug ...

Zai Lab Announces Updated Phase 1 Data for Zocilurtatug Pelitecan (formerly ZL-1310), Demonstrating Potential as a First-in-Class/Best-in-Class ...

ZL-1310, a DLL3 ADC, in patients with extensive stage ...

Median age was 66 years (range 36-79); 43% were female; 75% had an ECOG performance status of 1; 93% progressed after prior anti-PD-L1 therapy; ...

NCT07218146 | A Study of ZL-1310 Versus Investigator's ...

The purpose of this study is to evaluate the efficacy and safety of ZL-1310 compared to Investigator's Choice Therapy in participants with ...

ADC for SCLC Clears Phase I | Cancer Discovery

Among the 102 evaluable patients, 48 (47%) achieved a confirmed objective response. The median duration of response was 6.1 months, and median ...

Zai Lab Presents Positive Phase 1 Data for ZL-1310, a DLL3 ...

The updated Phase 1 results for ZL-1310 show strong anti-tumor activity, including intracranial responses with a manageable safety profile.

Investigational Antibody-drug Conjugate Shows Clinical ...

BOSTON – Zocilurtatug pelitecan (zoci), also known as ZL-1310, an investigational antibody-drug conjugate (ADC) that targets the protein ...