Nanjing Leads Biolabs starts Phase 3 test of LBL-024 in rare EP-NEC tumors
The randomized trial pits LBL-024 plus chemotherapy against a disease with no validated first-line drug and only a handful of DLL3-targeted rivals in earlier testing.
Executive Summary
- Nanjing Leads Biolabs Co.,Ltd has registered a Phase 3 trial testing its drug LBL-024 alongside platinum chemotherapy as a first-line treatment for advanced extrapulmonary neuroendocrine carcinoma, a rare and aggressive tumor type.
- The randomized study measures overall survival as its primary endpoint, the registrational bar for a first-line cancer therapy, with a large enough population to produce a decision-grade result if it completes on design.
- Competing programs targeting the same biology remain in earlier-stage testing across other neuroendocrine cancers, leaving this trial as one of the few late-stage efforts in this specific tumor type.
- The trial has not yet begun enrolling patients, and its completion date sits more than four years out, meaning the near-term news is the sponsor's strategic commitment, not a data readout.
The registration
Nanjing Leads Biolabs Co.,Ltd added a new Phase 3 trial to the public registry testing LBL-024 combined with platinum-based chemotherapy against chemotherapy alone as first-line treatment for advanced extrapulmonary neuroendocrine carcinoma, known as EP-NEC. The randomized, triple-masked study plans to enroll 280 patients across 17 sites in China, with overall survival as its primary endpoint. The trial is not yet recruiting, with a start date set for August 22, 2026, and a primary completion date of December 22, 2030. NCT07720193A Phase III Trial of LBL-024 Combined With Platinum-based Chemotherapy as First-line Treatment for Advanced EP-NECNCT07720193
What the trial tests
EP-NEC is a rare, fast-growing cancer arising outside the lungs, and the trial's use of overall survival as the primary measure sets a high bar: not response rate or progression-free survival, but whether patients live longer on LBL-024 plus chemotherapy than on chemotherapy alone. Secondary endpoints include objective response rate, duration of response, disease control rate, and progression-free survival, alongside pharmacokinetic and immunogenicity measures typical of a biologic combination regimen. The design is registrational, meaning a positive survival result could support a marketing application. NCT07720193A Phase III Trial of LBL-024 Combined With Platinum-based Chemotherapy as First-line Treatment for Advanced EP-NECNCT07720193
The competitive field
The broader neuroendocrine-carcinoma space includes several early-stage programs targeting DLL3, including Phanes Therapeutics' peluntamig in Phase 2, Molecular Partners AG's Pb-DOTAM-MAM279 in Phase 2, and SystImmune Inc.'s BL-M14D1 in Phase 1, but each is being tested in small cell lung cancer or broader neuroendocrine carcinoma populations rather than EP-NEC specifically. No competing trial in the searched field carries LBL-024's Phase 3, registrational design in this indication, leaving this study as the more advanced late-stage entrant among the identified programs. LBL-024's own molecular target is not established in available records, so this comparison rests on trial phase and indication rather than mechanism.
Sponsor track record
Nanjing Leads Biolabs has completed all seven of its previously reported trials with none terminated, and currently runs 19 trials across its pipeline, including 11 recruiting and one not yet recruiting, this one. That completion history gives the sponsor an operational base for running a multi-year, multi-site Phase 3 program, though the trial itself has not yet opened enrollment.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.