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| ID | Type | Description | Link |
|---|---|---|---|
| NIH/800-3/2/2 Jilid 18 (38) | Other Grant/Funding Number | Ministry of Health, Malaysia (MOH) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab + Standard Chemotherapy | Experimental | Patient will be receiving of low dose Nivolumab (40mg) combined with standard chemotherapy |
|
| Standard Chemotherapy | Active Comparator | Patient will be receiving standard chemotherapy alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab 40mg | Drug | Nivolumab is an immunotherapy medicine used to treat several cancers, including lung cancer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Determine the PFS of six-weekly Nivolumab 40mg combined with standard chemotherapy versus standard chemotherapy alone in NSCLC | From randomization to either the date of progression or death from any cause (whichever comes first) - up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Evaluate the OS of six-weekly Nivolumab 40mg combined with standard chemotherapy in NSCLC | 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) |
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Inclusion Criteria:
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.
At least 1 measurable lesion by RECIST 1.1 in solid tumors criteria.
Participants must have adequate organ function including the following laboratory values at the screening visit as per Table 2:
If a participant has brain or meningeal metastases, the participant must meet the following criteria:
A male participant must agree to use a contraception starting with the first dose of study treatment through the treatment period and for at least 90 days after the last dose of study treatment and refrain from donating sperm during this period.
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Can provide evaluable archival tumor tissue sample or willing to provide tissue from newly obtained core or excisional biopsy or fine needle aspirate (FNA) cell block form of tumor lesion not previously irradiated. Note: Formalin fixed, paraffin embedded (FFPE) tissue blocks or slides allowed.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Arvindran A/L Alaga | Contact | +6047407395 | arvindran_82@yahoo.com | |
| LEDANG Coordinating Center | Contact | +6047407395 | clintrial.ledang@cancerresearch.my |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Arvindran A/L Alaga | Hospital Sultanah Bahiyah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sultanah Bahiyah | Recruiting | Alor Star | Kedah | 05460 | Malaysia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 5, 2025 | May 28, 2025 |
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| Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, Docetaxel | Drug | Cisplatin, carboplatin, pemetrexed, paclitaxel, Gemcitabine, and docetaxel are chemotherapy drugs used to treat various types of cancer, including non-small cell lung cancer. |
|
|
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 |
| 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 | 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 | 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 NSCLC-SAQ | A 7-question survey that focuses on lung cancer symptoms, including cough, dyspnea, pain, fatigue, and appetite | 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 | 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 | 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 | 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 | From first dose to last dose of treatment plus follow-up - up to 27 months |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D000068437 | Pemetrexed |
| D000093542 | Gemcitabine |
| D017239 | Paclitaxel |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000600 | Amino Acids, Dicarboxylic |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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