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

Sponsor
Dr Arvindran A/L Alaga
Study ID
NCT07050043
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 19, 2025
Status verified
Jun 2025
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
123 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Nivolumab + Standard Chemotherapy
    Patient will be receiving of low dose Nivolumab (40mg) combined with standard chemotherapy
  • Active Comparator: Standard Chemotherapy
    Patient will be receiving standard chemotherapy alone.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From randomization to either the date of progression or death from any cause (whichever comes first) - up to 36 months ]

Central Contacts

Related Studies