Table of contents
- Clinical trials overview
- Small cell lung cancer studies
- Studies in other cancers
- Trial phases and endpoints
- Who can join these studies
- What the main results mean
Clinical trials overview
These studies are testing Lurbinectedin in people with different cancers, most often small cell lung cancer (SCLC).[1] Some trials study Lurbinectedin alone, and others study it with other cancer medicines such as atezolizumab, pembrolizumab, dostarlimab, irinotecan, or doxorubicin.[1][2][3]
The studies are interventional, which means patients receive a treatment and researchers measure the results.[1][2][3]
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.[1][2][3]
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).[1] The study also measures objective response rate (ORR), which means the share of patients whose tumors shrink or disappear on scans.[1]
The LUPER study is a Phase 1/2 trial in relapsed SCLC that combines Lurbinectedin with pembrolizumab.[2] 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.[2] In Phase 2, it measures ORR using RECIST 1.1, a standard system for tracking tumor changes on scans.[2]
The LAGOON trial is a Phase 3 study in relapsed SCLC after one prior platinum-containing treatment line.[6] It compares Lurbinectedin alone, Lurbinectedin with irinotecan, and the investigator’s choice of topotecan or irinotecan, and its main outcome is overall survival (OS).[6]
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.[3] Its main outcomes are progression-free survival (PFS) and overall survival, both measured after randomization.[3]
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.[4][5][7][8]
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.[4] It studies Lurbinectedin with irinotecan and measures ORR by RECIST 1.1.[4]
The metastatic leiomyosarcoma trial is a Phase 3 study testing Lurbinectedin plus doxorubicin against doxorubicin alone as first-line treatment.[5] Its main endpoint is PFS by an Independent Review Committee, which means a separate review team checks scan results.[5]
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.[7] Phase 1 finds the MTD and RD, and Phase 2 measures ORR.[7]
One older Phase 1/2 study looked at Lurbinectedin with irinotecan in pretreated patients with selected advanced solid tumors.[8] It first aimed to find the MTD and RD, then to learn more about antitumor activity in Phase 2.[8]
Trial phases and endpoints
Across these studies, Phase 1 trials mainly focus on safety, tolerability, and dose finding.[1][2][7][8]
Phase 2 trials mainly measure whether the treatment works, often using ORR based on RECIST 1.1.[2][4][7]
Phase 3 trials compare treatment strategies in larger groups and often use longer-term outcomes such as PFS and OS.[3][5][6]
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.[1][2]
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.[1][2][3][4][5][7][8]
One SCLC study requires measurable disease according to RECIST v.1.1, which means the cancer must be large enough to measure on scans.[1] The DSRCT study includes patients with progressive disease after one to three lines of systemic treatment and specifically mentions EWSR1-WT1 translocated disease.[4]
The endometrial cancer trial focuses on mismatch repair proficient, or pMMR, disease, which means the tumor keeps a certain DNA repair function.[7] The DSRCT study also includes patients aged 15 years or older, showing that some trials include both adults and young adults.[4]
What the main results mean
Overall survival is the length of time from randomization or treatment start until death from any cause.[3][5][6]
Progression-free survival is the time before the cancer gets worse or the patient dies.[3][5]
Objective response rate shows how many patients have a confirmed response, such as a complete response or partial response, based on scan results.[1][2][4][7]
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.[1][3][5][6][7]
