ZL-1310 for Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, ZL-1310, to determine its safety and effectiveness for individuals with small cell lung cancer, a rapidly spreading type of lung cancer. The study examines ZL-1310 both alone and in combination with other treatments like Atezolizumab and Carboplatin. It targets individuals whose cancer has spread or is at an advanced stage and who have already tried, or are just starting, treatments like chemotherapy. If this type of lung cancer has worsened after chemotherapy or treatment has not yet begun, this trial might suit you. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering the chance to be among the first to receive this new drug.
Will I have to stop taking my current medications?
The trial requires that you stop taking any systemic anti-cancer treatments or investigational products at least 3 weeks before starting the study treatment. Additionally, you must not be on strong CYP3A or CYP2D6 inhibitors within 14 days or 5 half-lives before the first study treatment. If you are on chronic systemic steroid therapy or immunosuppressive therapy, you must stop these 14 days or 5 half-lives before the study treatment, whichever is longer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that ZL-1310 is generally safe for patients with extensive-stage small cell lung cancer (ES-SCLC). One study found that many patients responded well to the treatment and managed the side effects effectively. When combined with Atezolizumab, ZL-1310 remained safe and enhanced the treatment's effectiveness against tumors.
The combination of ZL-1310 with Atezolizumab and Carboplatin has also been studied. Although specific safety details for this combination aren't provided, these drugs are commonly used in cancer treatments, suggesting they are generally safe. The FDA has granted ZL-1310 a fast track designation, highlighting its potential importance and safety in treatment.
Overall, ZL-1310, whether used alone or with these drugs, appears well-tolerated according to the available research.12345Why are researchers excited about this trial's treatments?
Researchers are excited about ZL-1310 for small cell lung cancer because it offers a unique approach compared to current standards like chemotherapy and immunotherapy. Unlike typical treatments, ZL-1310 is being tested both as a single-agent and in combination with Atezolizumab, an immunotherapy drug, and Carboplatin, a chemotherapy drug, which might enhance its effectiveness. This combination could potentially improve patient outcomes by targeting the cancer more aggressively and possibly reducing side effects associated with traditional therapies. Additionally, the trial explores dose optimization, which may lead to more personalized and effective treatment plans for patients.
What evidence suggests that this trial's treatments could be effective for small cell lung cancer?
Research shows that ZL-1310 could be a promising treatment for small cell lung cancer. Studies have found that ZL-1310 is generally safe and effective against tumors, even benefiting patients with brain metastases, which are difficult to treat. In this trial, participants may receive ZL-1310 alone or with Atezolizumab, an immune therapy, and Carboplatin. When combined with Atezolizumab, ZL-1310 has shown positive results in many patients. The FDA has granted ZL-1310 a special status to expedite its review, highlighting its potential. In summary, early evidence suggests ZL-1310 could be effective, especially when combined with treatments like Atezolizumab and Carboplatin.12567
Are You a Good Fit for This Trial?
This trial is for individuals with Small Cell Lung Cancer. Specific eligibility details are not provided, but typically participants would need to meet certain health standards and may be required to have a particular stage of cancer.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive ZL-1310 as a single agent or in combination with Atezolizumab and Carboplatin to determine the maximum tolerated dose
Dose Expansion
Participants receive the established dose level of ZL-1310 to further evaluate safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ZL-1310
Find a Clinic Near You
Who Is Running the Clinical Trial?
Zai Lab (Shanghai) Co., Ltd.
Lead Sponsor
Zai Lab (US) LLC
Industry Sponsor