10 Participants Needed

NMS-03305293 + Temozolomide for Small Cell Lung Cancer

Recruiting at 1 trial location
DR
Overseen ByDomenico Roberti
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new combination of treatments for individuals with Small Cell Lung Cancer (SCLC) who haven't responded to other therapies. It aims to determine if the combination of NMS-03305293 (an experimental treatment) and Temozolomide is safe, tolerable, and effective in reducing tumors. Participants should have SCLC that returned within six months after previous treatments, which may include chemotherapy and immune therapy. This study may suit those dealing with recurrent SCLC and who have experienced treatment failures with standard options. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking certain medications, especially those that are sensitive to CYP2D6 and CYP2C19 enzymes, and those that prolong the QTc interval. If you are on full-dose anticoagulants, your dose must be stable for at least 2 weeks before joining. Please discuss your current medications with the trial team to see if any changes are needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the drug NMS-03305293 is being tested with Temozolomide (TMZ) to assess its safety for people with Small Cell Lung Cancer (SCLC). As an early-stage study, the primary goal is to determine how well participants tolerate the treatment and to identify any side effects. Although detailed safety information for this drug combination is not yet available, the FDA's approval to proceed suggests that early lab tests indicated it is safe enough for human trials.

Temozolomide is already used to treat other types of cancer, providing some knowledge about its safety. However, since this is a new combination with NMS-03305293, monitoring for any side effects is crucial. Participants in this trial will help researchers identify any unexpected side effects when these drugs are used together.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of NMS-03305293 and Temozolomide for small cell lung cancer because it offers a novel approach compared to standard chemotherapy treatments like cisplatin and etoposide. NMS-03305293 is unique because it targets specific proteins involved in cancer cell growth, potentially enhancing the effectiveness of Temozolomide, a chemotherapy drug already used in other cancers. This combination could provide a more targeted attack on cancer cells, possibly leading to better outcomes and fewer side effects than traditional chemotherapies.

What evidence suggests that NMS-03305293 and Temozolomide could be effective for Small Cell Lung Cancer?

Research has shown that Temozolomide (TMZ) can treat certain cancers by damaging the DNA of cancer cells, potentially slowing their growth. It has proven especially helpful for aggressive cancers like small cell lung cancer (SCLC). In this trial, participants will receive a combination of NMS-03305293 and TMZ. NMS-03305293 blocks specific pathways that cancer cells need to grow and remains in the experimental stage. Early studies suggest that combining NMS-03305293 with TMZ might enhance the treatment's effectiveness compared to using TMZ alone. Although this research is still in its early stages, it offers hope for a better treatment option for SCLC.

Are You a Good Fit for This Trial?

This trial is for adults with extensive-stage Small Cell Lung Cancer (SCLC) who have already tried platinum-based therapy and immune therapy but saw their cancer return within 6 months. They should have had no more than three treatments, be relatively active (ECOG ≤2), and have measurable tumor growth after the most recent treatment.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.
I am using reliable birth control or practicing true abstinence.
I can swallow pills without breaking them.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks
1 visit (in-person)

Treatment

Participants receive NMS-03305293 and Temozolomide in 28-day cycles

12 months
Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • NMS-03305293
  • Temozolomide
Trial Overview The study tests NMS-03305293 combined with Temozolomide to assess safety, tolerability, effectiveness against tumors, and how the body processes the drugs. It's an open-label trial where everyone knows what treatment they're getting.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: NMS-03305293 and TemozolomideExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nerviano Medical Sciences

Lead Sponsor

Trials
14
Recruited
770+

Citations

NCT06931626 | Study of NMS-03305293 in Adult Patient ...The aim of this study is to determine the safety and tolerability, as well as to evaluate the anti-tumor efficacy and pharmacokinetics of NMS-03305293 in ...
Study of NMS-03305293 in Adult Patient With Relapsed Small ...This is an open-label study of NMS-03305293 with Temozolomide (TMZ) in patients with Small Cell Lung Cancer (SCLC).
Nerviano Medical Sciences announces FDA clearance ...The US Food and Drug Administration (FDA) has granted approval to proceed with two clinical studies in the relapse setting for small cell lung cancer and BRCA ...
NMS-03305293 + Temozolomide for Small Cell Lung CancerThe aim of this study is to determine the safety and tolerability, as well as to evaluate the anti-tumor efficacy and pharmacokinetics of NMS-03305293 in ...
Study of NMS-03305293 in Adult Patient With Relapsed Small ...This is an open-label study of NMS-03305293 with Temozolomide (TMZ) in patients with Small Cell Lung Cancer (SCLC). The aim of this study is to determine ...
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