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

NCT07050043 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2025-07-03

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Dr Arvindran A/L Alaga

    lead OTHER_GOV

Principal Investigators

  • Dr. Arvindran A/L Alaga · Hospital Sultanah Bahiyah

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-19
Primary Completion
2030-12-31
Completion
2030-12-31
FDA Drug
Yes

Countries

  • Malaysia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07050043 on ClinicalTrials.gov