A Phase 2 Platform Study of Immunomodulatory Compounds in ICI-refractory Non-small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
To learn if SAR445877 can help to control locally advanced or metastatic NSCLC in patients who have previously received ICI therapy.
Eligibility criteria
Qualifiers
Ability to understand and willingness to sign informed consent form (ICF) prior to initiation of the study and any study procedures.
Age ≥18 years. Because no dosing or adverse event data are currently available on the use of SAR445877 in participants <18 years of age, children are excluded from this study.
Prior immune checkpoint inhibitor (anti-PD-(L)1) exposure. Participants need to have received at least 6 weeks of exposure to anti-PD-(L)1 and developed disease progression. Treatment with neoadjuvant or adjuvant ICI is acceptable if participant developed progression within one year of start of ICI therapy.
One lesion suitable for repeat biopsy without significant risk to the participant.
Disqualifiers
History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drugs.
Participants who are pregnant or breastfeeding.
Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
Participants with a condition requiring systemic treatment with either corticosteroid (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study treatment initiation. Inhaled or topical steroids, and adrenal replacement steroid doses, are permitted in the absence of active autoimmune disease.
Trial design
Treatments tested in this trial
- SAR445877
Treatment groups
29 Participants
are divided into 1 treatment groupSponsors and collaborators
M.D. Anderson Cancer Center
Lead sponsor
Sanofi
Collaborator
Source ClinicalTrials.gov