Health Condition 1: C34- Malignant neoplasm of bronchus andlung
Conditions
Interventions
Intervention1: Low dose Nivolumab: Low dose Nivolumab, generic formulation, given as a flat dose of 40 milligrams by intravenous infusion in 100 millilitres normal saline over one hour, once every fou
Sponsors
Cancer Institute WIA
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged 18-80 years of age, Histologically documented stage III non-small cell lung cancer, Deemed inoperable and treated with concurrent chemoradiotherapy, Post CTRT, has a documented response of complete response, partial response, or stable disease, as per RECIST 1.1 criteria, PS 0-2, Patients cannot afford consolidation immunotherapy with Durvalumab which is the international standard of care, Negative urine pregnancy test
Exclusion criteria
Exclusion criteria: EGFR mutation or ALK fusion detected by polymerase chain reaction, immunohistochemistry, or next-generation sequencing, Has an underlying autoimmune disease, Has an untreated grade-2 or higher pneumonitis, Patients receiving systemic corticosteroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival, calculated from the day of initiation of chemoradiotherapy to the day of progression, or death, compared between the interventional arm and the historical comparator armTimepoint: 1 year and 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, calculated from the day of initiation of chemoradiotherapy to the day of death, compared between the interventional arm and the historical comparatorTimepoint: 2 years;The treatment completion rate, defined as the proportion of patients being started on low-dose nivolumab consolidation, who complete at least 5 of the planned 6 doses of immunotherapy, and have undergone a response assessment imagingTimepoint: 6 months;Objective response rate, defined as the composite of complete response and partial response as per the iRECIST criteria, after initiation of NivolumabTimepoint: 1 year;Median duration of response, defined as the time from a documented complete response or partial response, as per iRECIST criteria, till the date of progression, relapse, or deathTimepoint: 1 year and 2 years;The progression-free survival, overall survival, and objective response rates, stratified based on the PDL1 statusTimepoint: 2 years;The incidence of adverse events while on immunotherapy, including immune-related adverse eventsTimepoint: 1 year | — |
Countries
India
Contacts
Public ContactPragadeesh Thamaraiselvan
Cancer Institute WIA
Outcome results
None listed