Two Phase III trials showed superiority in terms of efficacy and tolerance of nivolumab in
second-line treatment compared to docetaxel in metastatic NSCLC in the general population, so
it is important to evaluate this treatment in PLWHIV (Patient Living With HIV) in maximum
security conditions, taking into account their specificities and complex underlying
immunological status. As NSCLC in PLWHIV is a rare tumour, a phase 2 trial, using DCR
(Disease Control Rate) data, would be able to recruit a sufficient number of patients, in a
reasonable period of time, to provide a proof of concept of the safety and efficacy of
nivolumab in this population. Therefore, we think that an open-label, one arm phase 2 trial,
with a rapid accrual, would be currently a crucial approach and a window of opportunity to
explore whether nivolumab could find its place in PLWHIV with NSCLC. Such a trial is
typically a trial for an academic sponsor, experienced in PLWHIV with NSCLC, which previously
showed its ability to recruit patients with such a rare disease as the IFCT did with the
IFCT-1001 CHIVA trial, testing carboplatin plus pemetrexed followed by pemetrexed.
Phase:
Phase 2
Details
Lead Sponsor:
Intergroupe Francophone de Cancerologie Thoracique
Collaborators:
ANRS, Emerging Infectious Diseases French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)