Low Dose Nivolumab With Chemotherapy vs Standard Chemotherapy as First-Line Treatment in Advanced or Metastatic NSCLC
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorDr Arvindran A/L Alaga
About this trial
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 criteria
Qualifiers
Male/female participants who are at least 18 years of age on the day of signing informed consent.
Histologically confirmed, treatment naïve, locally advanced, or metastatic (stage IIIB - IV (per AJCC version 8), squamous or non-squamous NSCLC with documented PD-L1 expression and is not eligible for definitive chemo-radiation curative therapy and surgery.
Patients must be treatment naïve with respect to locally advanced or metastatic disease. Patients who received prior treatment with curative intent for early stage disease and develop recurrent advanced/ metastatic disease must have completed treatment at least 6 months prior to first dose of IP.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
Disqualifiers
Presence of EGFR, ALK , ROS1 mutation(s).
Patients with locally advanced disease who can receive other potentially curative therapies, such as patients who can afford to pay for or can otherwise access clinically approved doses of immunotherapy.
Prior treatment with any anti-PD-1, anti-PD-L1 or any other antibody targeting an immune checkpoint.
Use of any live vaccines against infectious diseases within 28 days of first dose of IP(s).
Trial design
Treatments tested in this trial
- Nivolumab 40mg
- Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, Docetaxel
Treatment groups
123 Participants
are divided into 2 treatment groupsSponsors and collaborators
Dr Arvindran A/L Alaga
Lead sponsor
Hospital Sultanah Bahiyah
Sponsor institution
Source ClinicalTrials.gov