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Helen J Ross
P3.17 - Treatment of Locoregional Disease - NSCLC (Not CME Accredited Session) (ID 983)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Presentations: 1
- Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
P3.17-12 - Phase II Trial of Atezolizumab Before and After Chemoradiation for Unresectable Stage III NSCLC (AFT-16): Trial in Progress (ID 13929)
12:00 - 13:30 | Presenting Author(s): Helen J Ross
Cure is possible for a substantial minority of stage III NSCLC patients, but most will relapse after conventional chemoradiation (CRT). Combining checkpoint inhibition through PD-L1 blockade with CRT may attenuate tumor related immunosuppression via depletion of Tregs and clonal expansion of effector T-cells, thereby improving tumor immunogenicity. Further, CRT may reveal hidden antigens that can present additional targets to the reconstituting immune system. Whether anti-PD-L1 therapy before CRT will improve outcomes in this setting is the subject of this trial.
This phase II single arm Alliance Foundation Trials study (AFT-16, NCT03102242) explores safety and efficacy of atezolizumab before and after definitive CRT. 63 patients with stage III NSCLC, PS 0-1, no active autoimmune disease and no significant organ dysfunction will enroll at 15 Alliance sites. Participants receive 4 cycles of neoadjuvant atezolizumab 1200 mg IV q 21 days with restaging after cycles 2 and 4. Non-progressing patients undergo carboplatin and paclitaxel (C/P) weekly with 60 Gy RT followed by 2 cycles of C/P consolidation and adjuvant atezolizumab to complete one year of therapy. The primary endpoint is disease control rate (CR+PR+SD) after neoadjuvant atezolizumab. Secondary endpoints include ORR, PFS, OS, safety and QoL by the EORTC QLQ-30.
Correlatives include the role of PD-L1 and tumor mutation burden as predictive biomarkers. Tumor tissue is obtained at study entry, and plasma and immune cells are isolated at study entry, post neoadjuvant atezolizumab, post CRT, during adjuvant atezolizumab and at study end. Explorative endpoints include potential predictive biomarkers development that may define how atezolizumab affects the proportions of immunologic subtypes and immune activation using flow cytometry and T cell receptor immunophenotyping, multiplex immunohistochemistry and cytokine analysis.
The trial was activated on 11/1/17. As of 5/4/18, the trial is open at 8 centers with 14 patients enrolled.4c3880bb027f159e801041b1021e88e8 Result
Section not applicable8eea62084ca7e541d918e823422bd82e Conclusion
Section not applicable6f8b794f3246b0c1e1780bb4d4d5dc53
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