NCT06883630

A Phase Ib Study of RC148 as Monotherapy or Combination for Locally Advanced or Metastatic NSCLC

A Phase Ib, Multi-Cohort, Open-Label, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of RC148 Injection as Monotherapy or Combination Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer.

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy, safety, pharmacokinetics and immunogenicity of RC148 injection as a single agent or in combination for the treatment of locally advanced or metastatic non-small cell lung cancer

Detailed description

Primary objective: to evaluate the efficacy of RC148 injection as monotherapy or combination therapy in patients locally advanced or metastatic non-small cell lung cancer;

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	RC148 plus Carboplatin and Paclitaxel/pemetrexed	RC148; Carboplatin; Paclitaxel; pemetrexed
DRUG	RC148	RC148 Monotherapy

Timeline

• Start date: 2025-03-13
• Primary completion: 2026-08-31
• Completion: 2027-07-31
• First posted: 2025-03-19
• Last updated: 2026-03-05

Locations

24 sites across 1 country: China