An open label phase-2 randomized-clinical-trial to evaluate the efficacy and safety of low-dose nivolumab and low-dose chemotherapy in patients of advanced NSCLC with poor PS

An ECOG performance status of greater than 2 is seen in 30-50 percent of advanced NSCLC patients. This can be due to high disease burden, comorbidities, age or impaired nutrition. Therapeutic options for these patients are limited. Immune checkpoint inhibitors (ICIs) have limited efficacy in these patients. Moreover, the cost of ICIs is prohibitive for most patients in India. There is need to develop innovative and cost effective treatment strategies for this difficult to treat patient populations. We propose a study testing the feasibility of incorporating LdICI with low dose chemotherapy in carefully selected patients with poor PS. This would be the first study of LdIO plus CT in carefully selected, advanced NSCLC patients with poor PS using an adaptive, economically viable approach.

The primary objective of the study is to see improvement in 6 month PFS (progression free survival) rate and the secondary objectives are response rates, overall survival, change in quality of life, and corelation of response with PDL1 expression

This will be an Open-label phase-II randomised-control-trial. Patients with driver-mutation negative advanced NSCLC patients with poor PS will be enrolled. The intervention arm will receive : Nivolumab 20 mg every 21days (LdICI), plus weekly paclitaxel for 4-6 weeks. Contingent on improvement in ECOG PS by 1 point and score less than 2, carboplatin will be added to remaining three cycles, followed by maintenance. The comparator arm will receive the same chemotherapy regimen without nivolumab.

This study will test the feasibility of a new approach in this difficult to treat patient population, and if successful, will be able to provide a safe, efficacious and economically feasible option for their management.