KEY TAKEAWAYS
- LAGOON is a phase 3 study aimed to assess and compare the efficacy of the two experimental treatment regimens with the control arm in patients with relapsed SCLC.
- The primary criteria for inclusion in the trial are patients who are at least 18 years old, have a confirmed diagnosis of SCLC, and have received one round of chemotherapy.
- Provides evidence for the efficacy and safety of lurbinectedin-based treatment options compared to the standard treatment for patients with relapsed SCLC.
Lurbinectedin is a newly developed synthetic chemical compound that functions as a potent inhibitor of oncogenic transcription. It exhibits activity specifically in tumors that heavily rely on transcription processes for their growth and survival. A phase II Basket trial (NCT02454972) conducted on patients diagnosed with small cell lung cancer (SCLC) and receiving lurbinectedin as a second-line treatment demonstrated an overall response rate (ORR) of 35.2% and a median duration of response (DoR) of 5.3 months.
LAGOON is a randomized phase III clinical trial assessing two experimental treatment options (lurbinectedin alone, 3.2 mg/m2 D1 q3wk, or lurbinectedin 2 mg/m2 D1 plus irinotecan D1, D8 q3wk) compared to the control arm, Investigator’s Choice (topotecan D1-5 q3wk or irinotecan D1 q3wk as per label), in patients with relapsed small cell lung cancer (SCLC). Approximately 705 individuals will be registered for the study. Central randomization will be implemented using a 1:1:1 ratio. The stratification will be conducted based on the chemotherapy-free interval (CTFI) following the initial treatment (sensitive versus resistant), previous administration of anti-PD-(L)1 medication, presence of central nervous system (CNS) involvement at the beginning of the study, lactate dehydrogenase (LDH) level, and the Investigator’s preference for the Control Arm.
The primary criteria for inclusion encompass individuals at least 18 years old and with a confirmed diagnosis of small cell lung cancer (SCLC). They had also undergone one round of chemotherapy that includes platinum, with or without anti-PD-(L)1 treatment, and have a minimum of 30 days since their last treatment. Patients with central nervous system (CNS) metastases may be eligible for participation if they have undergone prior treatment and have remained radiologically stable for at least 4 weeks. The primary criteria for exclusion encompass patients who have not previously received platinum-based treatment, patients who have undergone treatment with more than one chemotherapy regimen (including re-administration of platinum-based therapy), and patients who have previously been treated with lurbinectedin, trabectedin, PM14, or topoisomerase I inhibitors. An autonomous Data Monitoring Committee will supervise the execution of the study. A Medical Review Board will assess the patient’s tumor at each designated evaluation point to determine the most optimal response and the specific date of objective response or progression/censoring based on RECIST v.1.1 guidelines.
Source: https://meetings.asco.org/abstracts-presentations/226034
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT05153239
Benjamin Besse, Luis G. Paz-Ares, Solange Peters, Federico Cappuzzo, Martin Reck, Antonio Calles, Raffaele Califano, Jose Antonio Lopez-Vilariño, Susie Veramendi, Carmen Maria Kahatt, Ali Hassan Zeaiter, Jacob Sands/A phase III study of lurbinectedin alone or in combination with irinotecan vs. investigator’s choice (topotecan or irinotecan) in patients with relapsed small cell lung cancer (SCLC; LAGOON trial)./J Clin Oncol 41, 2023 (suppl 16; abstr TPS8613) DOI 10.1200/JCO.2023.41.16_suppl.TPS8613.
