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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Nivolumab 40mg
DrugNivolumab is an immunotherapy medicine used to treat several cancers, including lung cancer.
Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, Docetaxel
DrugCisplatin, carboplatin, pemetrexed, paclitaxel, Gemcitabine, and docetaxel are chemotherapy drugs used to treat various types of cancer, including non-small cell lung cancer.
Treatment groups
123 Participants
are divided into 2 treatment groupsGroup A: Nivolumab + Standard ChemotherapyExperimental treatment 2 interventions
Group B: Standard ChemotherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Progression Free Survival (PFS)
Determine the PFS of six-weekly Nivolumab 40mg combined with standard chemotherapy versus standard chemotherapy alone in NSCLC
Time frame
From randomization to either the date of progression or death from any cause (whichever comes first) - up to 36 monthsSecondary outcomes
1
Overall Survival (OS)
Evaluate the OS of six-weekly Nivolumab 40mg combined with standard chemotherapy in NSCLC
Time frame
From the date of treatment commencement to the date death from any cause or the date of the last follow-up before final analysis (whichever comes first) - up to 36 months2
Patient-Reported Outcome Measure (PROM)
Evaluate PROM for six-weekly Nivolumab 40mg combined with standard chemotherapy in NSCLC. For each tool, domain scores and individual scores will be calculated using the scoring or developer's guidelines
Time frame
From the baseline until the end of treatment follow up or the last study follow up related to adverse event - up to 24 months3
PROM using EORTC QLQ-C30
A 30-question survey that looks at overall quality of life in cancer patients. It measures five functional dimensions (physical, role, emotional, cognitive, and social), three symptom items (fatigue, nausea/vomiting, and pain), six single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact) and global health and quality of life
Time frame
From the baseline until the end of treatment follow up or the last study follow up related to adverse event - up to 24 months4
PROM using EQ-5D-5L
A 6-question tool to assess general health and well-being through 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression
Time frame
From the baseline until the end of treatment follow up or the last study follow up related to adverse event - up to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dr Arvindran A/L Alaga
Lead sponsor
Hospital Sultanah Bahiyah
Sponsor institution
Source ClinicalTrials.gov