Authorised Therapeutic confirmatory (Phase III) Small-Cell Lung Cancer (SCLC)

A study of lurbinectedin in combination with atezolizumab compared with atezolizumab as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) following first-line induction therapy with carboplatin, etoposide and atezolizumab

EU CTIS ID: 2023-503868-16-00

What this study is testing

To evaluate the efficacy of maintenance treatment with lurbinectedin in combination with atezolizumab compared with atezolizumab based on Independent Review Facility (IRF)-assessed progression-free survival (PFS) and overall survival (OS)

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Histologically or cytologically confirmed ES-SCLC (per the VALG staging system)
  • Adequate hematologic and end-organ function
  • ECOG PS 0 or 1
  • No prior systemic treatment for ES-SCLC
  • Ongoing response or stable disease per RECIST v1.1 after completion of the induction therapy
  • Toxicities attributed to prior induction anti-cancer therapy or PCI resolved to Grade 1 or better

You likely can't join if

  • Presence or history of CNS metastases
  • Planned consolidative chest radiation
  • Uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, or lurbinectedin or trabectedin
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • Disease progression following induction treatment

The study team makes the final eligibility decision.

Where it's taking place

  • United States
  • United Kingdom
  • Korea, Republic of
  • Turkey
  • Mexico
  • Taiwan

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United States; United Kingdom; Korea, Republic of; Turkey; Mexico; Taiwan. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.