Study on Lurbinectedin Alone or with Irinotecan Compared to Topotecan or Irinotecan for Relapsed Small-cell Lung Cancer (LAGOON)

Sponsor: PharmaMar

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05153239

Provider View

This clinical trial is testing the effectiveness and safety of lurbinectedin, either alone or combined with irinotecan, against standard treatments like topotecan or irinotecan in patients with small-cell lung cancer that has returned after initial treatment.

Patient Parameters

Program Overview

This study involves patients with small-cell lung cancer (SCLC) whose cancer has returned after one round of platinum-based chemotherapy. It compares two new treatment options: lurbinectedin alone or lurbinectedin with irinotecan, against standard treatments chosen by the doctor, which could be topotecan or irinotecan. The trial will take place across multiple centers and will involve random assignment to one of the treatment groups. An independent committee will monitor the study to ensure safety and effectiveness.

Description

The trial will include about 705 adult patients with small-cell lung cancer (SCLC) who have previously been treated with a platinum-based chemotherapy. Patients will be randomly assigned to one of three groups: lurbinectedin alone, lurbinectedin with irinotecan, or a standard treatment chosen by the doctor (either topotecan or irinotecan). The study will be monitored by an independent committee to ensure patient safety and evaluate the effectiveness of the treatments. Participants must have a good performance status and meet specific health criteria to join the study.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Age 18 or older.
  • Confirmed diagnosis of small-cell lung cancer (SCLC).
  • Previously treated with one round of platinum-based chemotherapy, with or without certain immunotherapies.
  • At least 30 days since the last dose of first-line chemotherapy before cancer progression.
  • If there is a history of brain metastases, they must be treated and stable for at least 4 weeks, with no symptoms or need for steroids.
  • Good overall health with a performance status of 2 or less.
  • Adequate blood, kidney, liver, and metabolic function.
  • At least three weeks since last cancer treatment and recovery from any side effects.
  • Women of childbearing potential must use effective contraception during and after the study. Men must use condoms during treatment and for four months after.

Exclusion Criteria

  • Never treated with platinum-based chemotherapy or treated with more than one prior chemotherapy regimen.
  • Previous treatment with lurbinectedin, trabectedin, or certain other drugs.
  • Active or untreated brain metastases or cancer in the brain lining.
  • Candidates for local or regional therapy who have not completed or refused it.
  • Certain heart conditions or uncontrolled heart rhythm issues.
  • Chronic alcohol use or severe liver disease.
  • Active infections or serious non-healing wounds.
  • Recent oxygen therapy or lung diseases.
  • Other cancers treated with chemotherapy or radiation within the last five years, except certain skin or cervical cancers.
  • Inability to comply with study requirements.
  • Recent fungal infections or known HIV infection.
  • Chronic inflammatory bowel or liver diseases.
  • Rapidly increasing fluid around the lungs or heart.
  • Major illnesses that increase study risk.
  • Extensive prior radiation therapy.
  • Previous bone marrow or stem cell transplants.
  • Recent live vaccines.
  • Need for radiation therapy soon.
  • Allergies to study drugs.
  • Pregnant or breastfeeding women, or those unable to use effective contraception.

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