Table 1 Summary of trials cited as basis for FDA approval for drugs used in first line advanced NSCLC and their baseline and surveillance CNS imaging requirements
Trial Name | Drug and Indication | NCT | Baseline CNS Imaging Required | Surveillance CNS Imaging Required |
|---|---|---|---|---|
RELAY | Ramucirumab + Erlotinib, first line EGFR (19del, L858R) | NCT02411448 | MRI brain required for all subjects | As clinically indicated |
ALTA-1 L | Brigatinib, first line ALK mutated | NCT02737501 | MRI brain required for all subjects | At regular imaging intervals in all subjects |
Impower110 | Atezolizumab, first line PDL1 high | NCT02409342 | CT or MRI brain required for all subjects | At regular imaging intervals in subjects with CNS disease |
CHECKMATE-227 | Ipilimumab + Nivolumab, first line PDL1 > 1% | NCT02477826 | MRI brain required for all subjects | At regular imaging intervals in subjects with CNS disease |
IMpower130 | Atezolizumab with carboplatin/protein-bound paclitaxel, first line non-squamous | NCT02367781 | CT or MRI brain required for all subjects | As clinically indicated |
KEYNOTE-042 | Pembrolizumab, first line PDL1 > 1% | NCT02220894 | Unclear* | Unclear* |
KEYNOTE-407 | Pembrolizumab + carboplatin/paclitaxel, first line | NCT02775435 | CT or MRI brain accepted** | At regular imaging intervals in subjects with CNS disease |
ARCHER 1050 | Dacomitinib, first line EGFR (19del, L858R) | NCT01774721 | CT or MRI brain required for all subjects | As clinically indicated |
KEYNOTE-189 | Pembrolizumab + pemetrexed/carboplatin, first line | NCT02578680 | CT or MRI brain accepted** | At regular imaging intervals in subjects with CNS disease |
FLAURA | Osimertinib, first line EGFR (19del, L858R) | NCT02296125 | CT or MRI required if known/suspected CNS disease | At regular imaging intervals in subjects with CNS disease |
ASCEND-4 | Ceritinib, first line ALK mutated | NCT01828099 | CT or MRI brain required for all subjects | At regular imaging intervals in subjects with CNS disease |
ALEX | Alectinib, first line ALK mutated | NCT02075840 | MRI brain required for all subjects | At regular imaging intervals in all subjects |
KEYNOTE-024 | Pembrolizumab, first line PDL1 high | NCT02142738 | MRI brain required for all subjects | As clinically indicated |
SQUIRE | Necitumumab + gemcitabine/cisplatin, first line squamous | NCT00981058 | CT or MRI brain required for all subjects | At regular imaging intervals in subjects with CNS disease |