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Tumor Discovery Practice and consideration of master protocol design

Primary endpoint OS, DFS PFS, OS Pathological complete response (Cont’d...)

Sample size 6,000 – 8,000 planned for ALCHEMIST- Screening, 410 planned for ALCHEMIST-EGFR, 360 planned for ALCHEMIST- ALK, 903 planned for ALCHEMIST-PD-L1 1,536 planned for whole study 4,000 planned for study

5. Non-match study activity 1. EGFR mutation 2. ALK rearrangement 3. PD-L1 expression 1. BRAF mutation 2. PIK3CA mutation 3. KRAS or NRAS mutation 4. PTEN expression and wild type for BRAF, PIK3CA, KRAS, NRAS mutations HER23. hormone receptor

Target in a PD-L1+ TNBC

Drug(s) 7. Palbociclib 8. Rilotumumab 9. Talazoparib 10. Taselisib 11. Tremelimumab 1. Erlotinib 2. Crizotinib 3. Nivolumab 1. Specific BRAF mutated kinase inhibitor in combination with panitumumab (an EGFR targeted monoclonal antibody) with or without MEK inhibitor 2. Aspirin 3. AKT inhibitor and MEK inhibitor 4. HER1, 2 and 3 inhibitor 5. Capecitabine 1. AMG 386 with or without Trastuzumab 2. AMG 479 (Gan

Phase 2/3, multicenter, comparative, randomized trial Phase 2/3, multi-site, multi-arm, multi-stage, double-blind, comparative Phase 2, multicenter, single-blind, comparative, adaptive randomization trial

Design trial

Umbrella trial to evaluate molecularly defined subsets of operable, early stage (Stage IB-IIIA) lung inoperable advanced or metastatic colorectal cancer to ascertain whether the proposed intervention improves PFS compared with the control group in the biomarker-defined cohort and whether the biomarkers used identify one or more patient with greater responsiveness Platform trial to identify treatment regimens f

Description adenocarcinoma Umbrella trial in cohorts to therapy than an unselected group signatures

Registration number NCT02194738 NCT02193282 NCT02201992 NCT02595944 ISRCTN90061546 NCT01042379

Table 1. (Continued) Trial ALCHEMIST [24] FOCUS4 [25] I-SPY 2 [8,26]

Volume 2 Issue 2 (2023) 5 https://doi.org/10.36922/td.342