Lurbinectedin + Durvalumab for Small Cell Lung Cancer

CT
Overseen ByClinical Trial Disclosure & Transparency
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Jazz Pharmaceuticals
Must be taking: Platinum-based chemotherapy, Durvalumab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a combination of two drugs, lurbinectedin and durvalumab, can benefit people with extensive stage small cell lung cancer (ES-SCLC) whose cancer remains stable after initial treatment. The trial aims to determine if this drug combination is safe and effective in halting cancer growth. It targets individuals who have already undergone a specific type of chemotherapy and are otherwise in good health, with no current lung or brain issues. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant findings.

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

Research has shown that the combination of lurbinectedin and durvalumab is generally well-tolerated for treating small cell lung cancer. While side effects occur, they are usually manageable and not severe for most patients.

Lurbinectedin has been used in patients with advanced small cell lung cancer, and results support its use as a treatment option. Studies on its combination with durvalumab suggest it does not significantly increase the risk of serious side effects. Overall, the safety data indicate that this treatment is promising for patients, though more research is needed to confirm long-term safety.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of durvalumab and lurbinectedin for treating small cell lung cancer because it offers a new approach compared to the standard chemotherapy options like platinum-based drugs and etoposide. Durvalumab is an immune checkpoint inhibitor that helps the immune system better detect and attack cancer cells. Lurbinectedin, on the other hand, interferes with the cancer cells' ability to replicate DNA, thereby preventing their growth. This dual-action strategy of boosting immune response while directly targeting cancer cell replication holds promise for improved outcomes in patients with this aggressive cancer type.

What evidence suggests that this trial's treatments could be effective for small cell lung cancer?

Research has shown that using lurbinectedin with durvalumab may help treat extensive-stage small cell lung cancer (ES-SCLC). In this trial, participants will receive a combination of durvalumab and lurbinectedin after first-line induction therapy. Studies have found that lurbinectedin, when used as a second treatment option, can extend patients' lives and is generally safe. In everyday medical practice, it has effectively treated patients whose cancer has returned. Durvalumab boosts the immune system to fight cancer cells. Together, these drugs aim to control the cancer and improve outcomes after the first round of treatment, offering hope for patients with ES-SCLC.24567

Are You a Good Fit for This Trial?

Inclusion Criteria

I am fully active or can do light work despite my illness.
4. Must have a life expectancy of ≥ 12 weeks as assessed by the treating physician.
My blood counts and organ function have been normal for at least 7 days.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Treatment

Participants receive 4 cycles of durvalumab and platinum plus etoposide containing regimen

Approximately 12 weeks

Maintenance Treatment

Participants receive lurbinectedin in combination with durvalumab as maintenance therapy

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Durvalumab
  • Lurbinectedin

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Durvalumab and lurbinectedin treatment armExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jazz Pharmaceuticals

Lead Sponsor

Trials
252
Recruited
35,100+
Bruce C. Cozadd profile image

Bruce C. Cozadd

Jazz Pharmaceuticals

Chief Executive Officer since 2009

BA in Economics from Yale University, MBA from Stanford University

Dr. Austin profile image

Dr. Austin

Jazz Pharmaceuticals

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Jazz Pharmaceuticals Ireland Limited

Industry Sponsor

Trials
2
Recruited
250+

Citations

Current insights and future prospects—A systematic review.

Conclusions: LUR-IO shows promising efficacy and manageable safety profiles in extensive-stage small-cell lung cancer. However, further results ...

NCT07459634 | A Study of Lurbinectedin in Combination ...

The study will evaluate the safety and efficacy of lurbinectedin in combination with durvalumab as maintenance therapy in participants with ES-SCLC after first ...

Real-World Outcomes With Lurbinectedin in Second-Line ...

Lurbinectedin is a valid treatment option for patients with relapsed small cell lung cancer (SCLC) according to current management guidelines. •. This real- ...

Lurbinectedin Maintenance Yields Improved Survival in ES ...

During a live event, Tejas Patil, MD, discussed outcomes from small cell lung cancer trials including the recent IMforte study.

small cell lung cancer (ES-SCLC): real world response ...

This study aims to analyze the line-specific outcomes, duration of response patterns, and the impact of prior therapies on lurbinectedin effectiveness in SCLC, ...

Outcome and safety of lurbinectedin as compassionate use ...

Lurbinectedin has recently emerged in the treatment landscape of extensive stage (ES) small cell lung cancer (SCLC). Here we report the outcomes ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40618675/

Outcome and safety of lurbinectedin as compassionate use ...

Lurbinectedin represents a therapeutic option as compassionate use in patients with ES-SCLC, especially in those with a long CFI.