(CA018-001) A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Subjects with Advanced Non-small Cell Lung Cancer (FRACTION-Lung)
Johns Hopkins Kimmel Cancer Center in Baltimore
Phase II: To assess ORR (overall response) , DOR(durable response) & PFS (progression free survival) at 24 weeks of each FRACTION-Lung treatment combination in subjects with NSCLC and to evaluate the safety and tolerability of each FRACTION Lung treatment combination.
Subjects greater than 18 yrs old, will include subjects with advanced or metastatic NSCLC with good physical condition, for EGFR (test required) status (if + must have received TKI), for known ALK rearrangement (+ requires TKI). Must have received prior Platinum therapy for Progressive or recurrent disease (can have been adjuvant or neo), must have measureable disease, biopsy required pre, on treatment and at progression on study, meet the lab requirements of organ function. Exclusions: other malignancies, prior organ transplant, autoimmune disease, conditions requiring steroid treatment or other inter-current illnesses of concern.
There will be 3 tracks of patients based on their PDL1 status (requires testing) and history of immunotherapy. Track 1). Patients with PDL1 + tumors that are Immunotherapy naïve will have an 8 week run-in period of Nivolumab monotherapy q 2 weeks. Following the run in period, those with PR or CR (responders; 1a) will continue monotherapy for additional 2 years. Those with SD or (inadequate response; 1b) will be randomized to Nivo alone (6 cycles. Each cycle equal to 28 day) or a combination arm (6 cycles). Rapid progressors (1c) will go off treatment to follow up phase. Track 2: Anti PDL1 – patients with history of immunotherapy naïve will be randomized to Nivo alone or combination for 6 cycles. Track 3; AntiPDL1+/- with history of AntiPD1 or AntiPDL1 experience will be randomized to combination arm. Following treatment on 1a, 1b, 2 or 3 if PR or CR proceed to f/u, inadequate responder or physician prefers to continue therapy can be repeat current therapy (with medical monitor approval) or randomize to other available combination. For PD, proceed to follow up or randomize to other combination.
03/05/2019 05:03 AM