Table 1.

Examples of active umbrella trials matching patients to therapies based on molecular profiles

Program nameLead organizationDesignHistologyIndication# Expected to accruePrimary outcome measure(s)Clinicaltrials.gov identifier
ALCHEMISTUS National Cancer InstituteEnrichment, researchStage IB–IIIA lung adenocarcinomaScreening8,000Feasibility, genotyping for placement on adjuvant trialsNCT02194738
ECOG-ACRINRStage IB–IIIA adenocarcinoma of lung, with ALK fusionAdjuvant378OSNCT02201992
ALLIANCERStage IB–IIIA adenocarcinoma of lung, with activating EGFR mutationAdjuvant450OSNCT02193282
BATTLE-2MD AndersonA–RNSCLCMetastatic4508-Week DCRNCT01248247
FOCUS 4Cancer Research UKRColorectalMetastaticVariable (maximum 2,329)PFSEudraCT# 2012-005111-12 (37)
GEMMYale UniversityRAdvanced non-V600–mutated metastatic melanomaMetastatic96BORRNCT02094872
ISPY-2Quantum Leap Healthcare CollaborativeA–RLocally advanced breast cancerNeo-Adjuvant800pCRNCT01042379
LUNG-MAPSWOG and NCTNRSquamousMetastatic10,000 (screening)PFSNCT02154490
SAFIR-02 breastUNICANCERRMetastatic non-HER2+ breast cancerMetastatic400 (screening) 210 (randomized)PFSNCT02299999
SAFIR-02 lungUNICANCERRNSCLCMetastatic650 (screening) + 220 (treatment)PFSNCT02117167

Abbreviations: A-R, adaptively randomized; ALLIANCE, Alliance for Clinical Trials in Oncology; BORR, best overall response rate; DCR, disease control rate; ECOG- ACRIN, Eastern Cooperative Oncology Group and the American College of Radiology Imaging Network; NCTN, National Clinical Trials Network; NR, nonrandomized; NSCLC, non–small cell lung cancer; OS, overall survival; pCR, rate of pathologic complete response; PFS, progression-free survival; R, randomized; SWOG, Southwest Oncology Group.