Zepzelca (lurbinectedin)

P2, N=30, Not yet recruiting, Sichuan University

P2/3, N=180, Not yet recruiting, AbbVie | Trial completion date: May 2029 --> Sep 2031

P1, N=22, Recruiting, Emory University | Trial completion date: Jul 2025 --> Jul 2027 | Trial primary completion date: Jul 2025 --> Jul 2026

P3, N=540, Active, not recruiting, Daiichi Sankyo | Recruiting --> Active, not recruiting

P2/3, N=180, Not yet recruiting, AbbVie | N=730 --> 180 | Trial completion date: Sep 2031 --> May 2029 | Trial primary completion date: Sep 2031 --> May 2029

Patients with small cell lung cancer (SCLC) have poor prognosis and limited treatment options beyond first-line therapy. Secondary endpoints include ORR by investigator; progression-free survival, duration of response, disease control rate, and time to response, all by BICR and investigator; patient-reported outcomes; and safety. IDeate-Lung02 will ascertain whether I-DXd treatment after only one prior line of systemic treatment improves outcomes for patients with relapsed SCLC compared with topotecan, amrubicin, or lurbinectedin.Clinical Trial Registration: NCT06203210.

P2, N=46, Enrolling by invitation, National Cancer Center, Korea | Active, not recruiting --> Enrolling by invitation

Furthermore, LUR significantly restrained the in vivo growth of iCCA cells in the CAM model. Our data indicate that TRB and LUR possess strong anti-proliferative and pro-apoptotic activities and could represent promising therapeutic agents for the treatment of iCCA.

These organoids were used to evaluate lurbinectedin in comparison with standard carboplatin and paclitaxel. Importantly, this work does not advocate for lurbinectedin as a superior therapy but, rather, demonstrates the utility of organoid models in uncovering drug-specific genomic effects. Our findings underscore the critical need for expanded testing using clinically relevant models to identify more effective strategies against PARPi-resistant disease.

For limited-stage SCLC (LS-SCLC) treated with radical chemo-radiotherapy, the ICI durvalumab is now approved as a consolidation therapy to reduce relapse risk...For relapsed SCLC, treatment options include chemotherapies such as topotecan or lurbinectedin and carboplatin/etoposide rechallenge. The delta-like ligand 3-targeting bispecific T-cell engager (BiTE), tarlatamab, has been approved by the FDA for ES-SCLC with disease progression on or after platinum-based chemotherapy and is being evaluated in earlier lines of treatment...Several antibody-drug conjugates, including sacituzumab govitecan, are being tested in clinical trials and have demonstrated encouraging efficacy...Circulating tumour DNA and circulating tumour cells have demonstrated potential for prognostication, molecular subtyping and tumour monitoring. Further research remains essential to support treatment stratification, prolong treatment responses, overcome resistance and ultimately improve outcomes for this devastating disease.

P1, N=11, Completed, PharmaMar | Recruiting --> Completed

Lurbinectedin had strong effects on three of the selected cell lines by inducing G2/M arrest, promoting apoptosis/necrosis, and reducing clonogenic survival, suggesting that it may be a promising chemotherapeutic agent in soft tissue sarcoma treatment. The effect on the fourth cell line was limited, as well as the effect on cell migration. Single-dose irradiation occasionally interfered with the effects of Lurbinectedin, whereas adding fractionated irradiation caused an additional decrease in clonogenic survival, indicating that the combination of Lurbinectedin with fractionated ionizing radiation may have promising effects.