NCT07050043

Low Dose Nivolumab With Chemotherapy vs Standard Chemotherapy as First-Line Treatment in Advanced or Metastatic NSCLC

A Phase III RCT Comparing Low Dose Immunotherapy (Nivolumab) Combined With Standard Chemotherapy vs Standard Chemotherapy as First-line Treatment in Patients With Locally Advanced or Metastatic NSCLC

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 123 (estimated)
• Sponsor: Dr Arvindran A/L Alaga · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, two-arm randomized, parallel group design trial to evaluate superiority and safety of low dose Nivolumab (40mg) combined with standard chemotherapy versus standard chemotherapy alone in patients with non-small cell lung cancer.

Detailed description

Eligible subjects who satisfy the inclusion and exclusion criteria will be randomized 2:1 into 2 arms (Low dose nivolumab arm consisting of six-weekly 40mg Nivolumab plus 4-6\* cycles of Cisplatin or Carboplatin plus Pemetrexed or Gemcitabine or Docetaxel or Paclitaxel per local practice, versus standard chemotherapy alone, consisting 4-6\* cycles of Cisplatin or Carboplatin plus Pemetrexed or Gemcitabine or Docetaxel or Paclitaxel per local practice.

Conditions

• NSCLC (Non-small Cell Lung Carcinoma)
• First Line Therapy
• Locally Advanced/Metastatic NSCLC

Interventions

Type	Name	Description
DRUG	Nivolumab 40mg	Nivolumab is an immunotherapy medicine used to treat several cancers, including lung cancer.
DRUG	Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, Docetaxel	Cisplatin, carboplatin, pemetrexed, paclitaxel, Gemcitabine, and docetaxel are chemotherapy drugs used to treat various types of cancer, including non-small cell lung cancer.

Timeline

• Start date: 2025-05-19
• Primary completion: 2030-12-31
• Completion: 2030-12-31
• First posted: 2025-07-03
• Last updated: 2025-07-03

Locations

1 site across 1 country: Malaysia

Regulatory

• FDA-regulated drug study