RecruitingPhase 3NCT07050043

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


Sponsor

Dr Arvindran A/L Alaga

Enrollment

123 participants

Start Date

May 19, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial compares a low-dose immunotherapy approach — a reduced dose of nivolumab (an immune-stimulating drug) combined with standard chemotherapy — against chemotherapy alone for people with advanced or metastatic non-small cell lung cancer (NSCLC) who have not received prior treatment. **You may be eligible if:** - You are 18 or older with a confirmed diagnosis of advanced or metastatic NSCLC (stage IIIB–IV) - You have not previously received treatment for advanced disease (prior early-stage treatment ended at least 6 months ago) - You are in good functional condition (ECOG performance status 0 or 1) - You have at least one measurable tumor - You have adequate organ function (blood counts, kidney, liver) - You agree to use contraception if applicable **You may NOT be eligible if:** - Your cancer has certain genetic mutations (EGFR, ALK, or ROS1) - You have previously received immunotherapy (anti-PD-1 or anti-PD-L1 drugs) - You have active or severe lung disease, autoimmune disease, or serious infection - You are pregnant or breastfeeding - You have active hepatitis B or C, or HIV - You have had another cancer within the past 2 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNivolumab 40mg

Nivolumab is an immunotherapy medicine used to treat several cancers, including lung cancer.

DRUGCisplatin, 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.


Locations(1)

Hospital Sultanah Bahiyah

Alor Star, Kedah, Malaysia

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NCT07050043


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