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.
Eligible subjects who satisfy the inclusion and exclusion criteria will be randomized 2:1 into 2 arms (Low dose nivolumab arm consisting of six-weekly 40mg Nivolumab plus 4-6\* cycles of Cisplatin or Carboplatin plus Pemetrexed or Gemcitabine or Docetaxel or Paclitaxel per local practice, versus standard chemotherapy alone, consisting 4-6\* cycles of Cisplatin or Carboplatin plus Pemetrexed or Gemcitabine or Docetaxel or Paclitaxel per local practice.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
123
Nivolumab is an immunotherapy medicine used to treat several cancers, including lung cancer.
Cisplatin, carboplatin, pemetrexed, paclitaxel, Gemcitabine, and docetaxel are chemotherapy drugs used to treat various types of cancer, including non-small cell lung cancer.
Hospital Sultanah Bahiyah
Alor Star, Kedah, Malaysia
RECRUITINGProgression 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 months
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 months
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 months
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 months
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 months
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PROM using NSCLC-SAQ
A 7-question survey that focuses on lung cancer symptoms, including cough, dyspnea, pain, fatigue, and appetite
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 months
Incidence of Treatment-Emergent Adverse Events (TEAEs)
To assess the safety and tolerability profile of study regimens, measured by the number and percentage of participants experiencing at least one TEAE, as defined by CTCAE v5.0
Time frame: From first dose to last dose of treatment plus follow-up - up to 27 months
Incidence of Serious Adverse Events (SAEs)
To assess the safety and tolerability profile of study regimens, measured by the number and percentage of participants experiencing at least one SAE, as defined by CTCAE v5.0
Time frame: From first dose to last dose of treatment plus follow-up - up to 27 months
Incidence of Treatment-Related Discontinuations
To assess the safety and tolerability profile of study regimens, measured by the number and percentage of participants who discontinue treatment due to adverse events, as defined by CTCAE v5.0
Time frame: From first dose to last dose of treatment plus follow-up - up to 27 months
Incidence of Treatment-Related Deaths
To assess the safety and tolerability profile of study regimens, measured by the number and percentage of participants who die due to adverse events, as defined by CTCAE v5.0
Time frame: From first dose to last dose of treatment plus follow-up - up to 27 months