Trial intelligence / Profile preview

Low-Dose Nivolumab + Chemotherapy in Advanced NSCLC

NCT07050043Phase 3

Key facts

Status: Recruiting
Start: May 2025
Primary completion: Dec 2030
Countries: 1
Modality: Monoclonal Antibodies

Drugs: nivolumab
Conditions: non-small cell lung cancer (NSCLC)

Overview

Phase 3, randomised, open-label trial of nivolumab in non-small cell lung cancer (NSCLC) (2 arms). Primary endpoint: Progression Free Survival at 36 months. Started May 2025; status: recruiting.

Design

2 arms

Study design: RandomizedOpen-label

Nivolumab + Standard Chemotherapy
Low dose Nivolumab (40mg) combined with standard chemotherapy (Cisplatin/Carboplatin + Pemetrexed/Gemcitabine/Docetaxel/Paclitaxel)
Standard Chemotherapy
Standard chemotherapy alone (Cisplatin/Carboplatin + Pemetrexed/Gemcitabine/Docetaxel/Paclitaxel)

Who it enrols

Adult patients with treatment-naive, locally advanced or metastatic NSCLC (Stage IIIB-IV) with documented PD-L1 expression. Patients with EGFR, ALK, or ROS1 mutations are excluded.

Endpoints

Primary

Progression Free Survival36 months

Secondary

Overall Survival36 months
Patient-Reported Outcome Measures24 months
Incidence of Treatment-Emergent Adverse Events27 months
Incidence of Serious Adverse Events27 months

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