In short
Clinical trials are studying Lurbinectedin in several cancers, especially small cell lung cancer. These studies look at safety, the best dose, and how well it works alone or with other treatments. Some trials also include endometrial cancer, leiomyosarcoma, and desmoplastic small round cell tumor.
Key points
- Clinical trials of Lurbinectedin are mainly focused on small cell lung cancer, including relapsed and extensive-stage disease. The studies also include other cancers such as endometrial cancer, metastatic leiomyosarcoma, desmoplastic small round cell tumor, and selected advanced solid tumors. Trial phases range from Phase 1 to Phase 3, so the research covers dose-finding, safety, and larger efficacy comparisons. Common endpoints include maximum tolerated dose, recommended dose, objective response rate, progression-free survival, and overall survival. Some trials test Lurbinectedin alone, while others combine it with medicines such as atezolizumab, pembrolizumab, dostarlimab, irinotecan, or doxorubicin.
Clinical trials overview
These studies are testing Lurbinectedin in people with different cancers, most often small cell lung cancer (SCLC). Some trials study Lurbinectedin alone, and others study it with other cancer medicines such as atezolizumab, pembrolizumab, dostarlimab, irinotecan, or doxorubicin.
The studies are interventional, which means patients receive a treatment and researchers measure the results.
Small cell lung cancer studies
Most of the trial data here focus on SCLC, including relapsed disease, extensive-stage disease, and cancer that progressed after platinum-based chemotherapy.
One Phase 1 study in advanced SCLC is testing Lurbinectedin with atezolizumab and plans to find the maximum tolerated dose (MTD) and recommended dose (RD). The study also measures objective response rate (ORR), which means the share of patients whose tumors shrink or disappear on scans.
The LUPER study is a Phase 1/2 trial in relapsed SCLC that combines Lurbinectedin with pembrolizumab. In Phase 1, it looks for the MTD and RD and checks for dose-limiting toxicities, which are side effects serious enough to stop dose increases. In Phase 2, it measures ORR using RECIST 1.1, a standard system for tracking tumor changes on scans.
The LAGOON trial is a Phase 3 study in relapsed SCLC after one prior platinum-containing treatment line. It compares Lurbinectedin alone, Lurbinectedin with irinotecan, and the investigator’s choice of topotecan or irinotecan, and its main outcome is overall survival (OS).
Another Phase 3 study is testing Lurbinectedin with atezolizumab as maintenance treatment in extensive-stage SCLC after first-line induction with carboplatin, etoposide, and atezolizumab. Its main outcomes are progression-free survival (PFS) and overall survival, both measured after randomization.
Studies in other cancers
Lurbinectedin is also being studied in advanced desmoplastic small round cell tumor (DSRCT), metastatic leiomyosarcoma, advanced/recurrent endometrial cancer, and selected advanced solid tumors.
The DSRCT Phase 2 study includes adult and young adult patients aged 15 years or older with progressive, locally advanced or metastatic disease and EWSR1-WT1 translocated DSRCT. It studies Lurbinectedin with irinotecan and measures ORR by RECIST 1.1.
The metastatic leiomyosarcoma trial is a Phase 3 study testing Lurbinectedin plus doxorubicin against doxorubicin alone as first-line treatment. Its main endpoint is PFS by an Independent Review Committee, which means a separate review team checks scan results.
The LiDer trial is a Phase 1/2 study in advanced or recurrent endometrial cancer after platinum-based chemotherapy, and it tests Lurbinectedin with dostarlimab. Phase 1 finds the MTD and RD, and Phase 2 measures ORR.
One older Phase 1/2 study looked at Lurbinectedin with irinotecan in pretreated patients with selected advanced solid tumors. It first aimed to find the MTD and RD, then to learn more about antitumor activity in Phase 2.
Trial phases and endpoints
Across these studies, Phase 1 trials mainly focus on safety, tolerability, and dose finding.
Phase 2 trials mainly measure whether the treatment works, often using ORR based on RECIST 1.1.
Phase 3 trials compare treatment strategies in larger groups and often use longer-term outcomes such as PFS and OS.
Some trials also describe special imaging checks, such as baseline scans and repeat scans every few weeks or every few cycles, so researchers can track tumor changes over time.
Who can join these studies
Each trial has its own rules, but most are for people with advanced, relapsed, recurrent, or metastatic cancer who have already had previous treatment.
One SCLC study requires measurable disease according to RECIST v.1.1, which means the cancer must be large enough to measure on scans. The DSRCT study includes patients with progressive disease after one to three lines of systemic treatment and specifically mentions EWSR1-WT1 translocated disease.
The endometrial cancer trial focuses on mismatch repair proficient, or pMMR, disease, which means the tumor keeps a certain DNA repair function. The DSRCT study also includes patients aged 15 years or older, showing that some trials include both adults and young adults.
What the main results mean
Overall survival is the length of time from randomization or treatment start until death from any cause.
Progression-free survival is the time before the cancer gets worse or the patient dies.
Objective response rate shows how many patients have a confirmed response, such as a complete response or partial response, based on scan results.
These results help researchers see whether Lurbinectedin is safe enough, whether the dose is workable, and whether the treatment may help control cancer better than other options.