Abstract 613TiP
Background
Immune checkpoint inhibitors (ICIs) have become integral part of lung cancer treatment. However, high cost limits accessibility in low and middle income countries. Flat dose- response relation, high receptor occupancy (PD1) at 1/10th of recommended dose as shown in phase I trials and preliminary clinical experience showing responses at low doses, set a background to further explore the low dose strategies for ICIs. In this study we intend to evaluate efficacy of low dose nivolumab in combination with chemotherapy as neaoadjuvant treatment in potentially resectable non small cell lung cancer in terms of major pathological response.
Trial design
Methodology: • This is being continued as a single centre, phase II randomised clinical trial. Potentially resectable non-small cell lung cancer of stage IIA to stage IIIA and Stage IIIB with single station N2 lymph node as per AJCC 8th edition) patients, with ECOG PS 0-1,age 18-75 years, preserved vital organ functions, are being enrolled. Eligible patients are being randomised in 1:1 ratio to receive either neoadjuvant chemo-immunotherapy using low dose nivolumab (at 40 mg flat dose every 3 weekly) or chemotherapy alone for 3 cycles. After a gap of at least 3 weeks, patients in both treatment arms are evaluated radiologically and undergo surgery. Primary end point is major pathological response rate (MPR) and secondary endpoints are radiological response rates and safety. Post surgery adjuvant treatment will be as per clinician discretion based on histopathology report. Assuming MPR rates of 45% with chemo-immunotherapy and 10% with chemotherapy alone, with power of 80% and alpha error of 5%, we will randomize 25 patients in each group (total 50). Additional patients will be recruited to compensate for consent withdrawal, protocol violations and loss of follow up. This trial is approved by the Institute Ethics committee and registered with clinical trial registry of India (CTRI no 2023/02/050126).
Clinical trial identification
Legal entity responsible for the study
All India Institute of Medical Sciences, New Delhi.
Funding
Indian Council of Medical Research, New Delhi.
Disclosure
The author has declared no conflicts of interest.