Second-Line Lurbinectedin in Small Cell Lung Cancer

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As reported in The Lancet Oncology by Trigo et al, second-line treatment with the selective oncogenic transcription inhibitor lurbinectedin showed activity in patients with small cell lung cancer included in a phase II basket trial.

The trial includes cohorts representing nine different tumor types.

Study Details

In the study, conducted at sites in both the United States and Europe, 105 patients with small cell lung cancer who had received prior platinum-based chemotherapy and had no brain metastases were given lurbinectedin at 3.2 mg/m2 via 1-hour infusion every 3 weeks until disease progression or unacceptable toxicity. Patients could have received only one previous chemotherapy-containing line of treatment, with treatment ending at a minimum of 3 weeks before study entry. The primary outcome measure was investigator-assessed response.


Median follow-up was 17.1 months. Objective responses (all partial responses) were observed in 37 patients (35.2%), with stable disease observed in an additional 35 patients (33.3%).  


  • Objective response was observed in 35% of patients.
  • Activity appeared to be greater in patients with a chemotherapy-free interval ≥ 90 days.

Objective response rates were 22% among 45 patients with a chemotherapy-free interval < 90 days and 45% among 60 patients with a ≥ 90-day interval, with respective response durations of 4.7 and 6.2 months. Among all patients, median progression-free survival was 3.5 months (2.6 vs 4.6 months in the < 90-day chemotherapy-free interval group vs the ≥ 90-day interval group) and median overall survival was 9.3 months (5.0 vs 11.9 months).  

Adverse Events

The most common grade 3 or 4 adverse events were hematologic, including neutropenia in 46% of patients, leukopenia in 29%, anemia in 9%, and thrombocytopenia in 7%. The most common treatment-related nonhematologic grade 3 or 4 adverse events were fatigue (7%) and febrile neutropenia (5%). Serious treatment-related adverse events occurred in 10% of patients, with neutropenia and febrile neutropenia being the most common (five patients [5%] each). No treatment-related deaths were reported.

The investigators concluded, “Lurbinectedin was active as second-line therapy for small cell lung cancer in terms of overall response and had an acceptable and manageable safety profile. Lurbinectedin could represent a potential new treatment for patients with small cell lung cancer, who have few options especially in the event of a relapse, and is being investigated in combination with doxorubicin as second-line therapy in a randomized phase III trial [ATLANTIS; NCT02566993].”

José Trigo, MD, of Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga, is the corresponding author for The Lancet Oncology article.

Disclosure: The study was funded by PharmaMar. For full disclosures of the study authors, visit

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