Actively Recruiting
Low Dose Nivolumab With Chemotherapy vs Standard Chemotherapy as First-Line Treatment in Advanced or Metastatic NSCLC
Led by Dr Arvindran A/L Alaga · Updated on 2025-07-03
123
Participants Needed
1
Research Sites
293 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Low Dose Nivolumab With Chemotherapy vs Standard Chemotherapy as First-Line Treatment in Advanced or Metastatic NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older
- Histologically confirmed, treatment-nafve locally advanced or metastatic (stage IIIB-IV) NSCLC with documented PD-L1 expression
- Not eligible for definitive chemo-radiation curative therapy or surgery
- Treatment nafve for locally advanced or metastatic disease; prior curative treatment for early stage disease completed at least 6 months before study treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- At least one measurable tumor lesion by RECIST 1.1 criteria
- Adequate organ function per laboratory values at screening
- Brain metastases allowed if asymptomatic, treated, stable, and no steroids required for at least 2 weeks before treatment
- Male participants agree to use contraception during treatment and for at least 90 days after last dose
- Female participants must not be pregnant or breastfeeding and either not of childbearing potential or agree to contraception during treatment and for 180 days after last dose
- Able to provide evaluable tumor tissue sample (archival or newly obtained biopsy)
You will not qualify if you...
- Presence of EGFR, ALK, or ROS1 mutations
- Locally advanced disease patients eligible for other potentially curative therapies
- Prior treatment with anti-PD-1, anti-PD-L1, or other immune checkpoint antibodies
- Use of live vaccines within 28 days before first study treatment
- Medical conditions making immunotherapy hazardous, including interstitial lung disease, recent serious infections
- Use of high-dose corticosteroids (>10 mg/day prednisone or equivalent) or immunosuppressive drugs
- Active hepatitis B or C infection or positive HIV test at screening
- Known allergy to study drugs or their components
- History of autoimmune disease requiring immunosuppressive therapy
- History of second cancer within 2 years prior to enrollment
- Life expectancy of 3 months or less
- Positive pregnancy test within 72 hours before treatment allocation for women of childbearing potential
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Sultanah Bahiyah
Alor Star, Kedah, Malaysia, 05460
Actively Recruiting
Research Team
D
Dr. Arvindran A/L Alaga
CONTACT
L
LEDANG Coordinating Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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