Active — Not RecruitingPhase 2

A Study to Compare Uliledlimab Combined With Sintilimab and Chemotherapy Versus Sintilimab Combined With Chemotherapy in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic Non-small Cell Lung Cancer

China150 participantsStarted 2025-01-09

Plain-language summary

This is a Phase II, randomized, open-label, active-controlled, multicenter study to compare intravenous uliledlimab combined with sintilimab and chemotherapy versus sintilimab combined with chemotherapy in patients with previously untreated locally advanced unresectable or metastatic NSCLC who are not suitable for targeted therapies such as EGFR or ALK. Eligible subjects will be randomly assigned in a 1:1 ratio to receive either uliledlimab combined with sintilimab and chemotherapy or sintilimab combined with chemotherapy. Enrolled subjects will first enter a safety run-in period. When at least 12 subjects have been randomly assigned to Group A and have received ≥ 1 dose of study drug (with a total of approximately 24 subjects), enrollment will be suspended for safety evaluation. The safety evaluation period will last 3 weeks, during which safety, tolerability, and PK data of uliledlimab combined with sintilimab and chemotherapy will be collected and evaluated by the Safety Review Committee (SRC). The SRC will decide through discussion whether to proceed to the next stage of randomized enrollment, whether additional subjects need to be enrolled for safety evaluation, or whether the study treatment should be terminated due to high safety risks. After the SRC reaches a unanimous resolution, enrollment will continue until a total of approximately 150 subjects are enrolled. All 150 subjects will be included in the final efficacy analysis. If 3 or more subjects experience Grade ≥ 3 treatment-related AEs that are unrelieved and lead to discontinuation of all study drugs during the safety run-in period, enrollment in the next stage will be terminated.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients aged ≥ 18 years at the time of signing the ICF.
✓. Patients with histologically or cytologically confirmed stage IIIB, IIIC, or IV NSCLC who are not suitable for radical surgery and/or radiotherapy.
✓. Patients who have not received prior systemic therapy for their locally advanced or metastatic diseases.
✓. Patients with measurable lesions as assessed by the investigator at the study site based on RECIST v1.1. Target lesions located in a previously irradiated region will be considered measurable only if there is documented evidence of disease progression.
✓. Patients with non-squamous NSCLC who are confirmed to have no EGFR-sensitive mutations or ALK fusions.
✓. atients with known PD-L1 and CD73 expression status in tumor tissue: it will be tested by the central laboratory for PD-L1 expression levels using the PD-L1 IHC 22C3 pharmDx assay, and CD73 expression levels using the CD73 antibody assay.
✓. Patients with a life expectancy of at least 3 months.
✓. Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion criteria

What they're measuring

Progression-free survival (PFS)

Timeframe: From the date of randomization to the date of first documented disease progression (assessed by a blinded independent central review [BICR] according to RECIST v1.1) or death from any cause, whichever occurs first,assessed up to 6months.

Trial details

NCT IDNCT07005336

SponsorTJ Biopharma Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08-30

View on ClinicalTrials.gov More Non Small Cell Lung Cancer trials