From: Emerging evidence and treatment paradigm of non-small cell lung cancer
Oligometastases | ||||
---|---|---|---|---|
Therapeutic regimens | Status | NCT No | Sample size | Primary endpoint |
Standard medical therapy ± surgery/RT | Phase III | NCT03827577 (OMEGA) | 195 | OS |
Chemotherapy/erlotinib/pembrolizumab ± RT | Phase II/III | NCT03137771 (NRG-LU002) | 400 | PFS/OS |
Systemic anti-cancer therapy ± RT | Phase III | NCT02417662 (SARON) | 340 | OS |
Standard of Care ± RT | Phase II/III | NCT02759783 (CORE) | 206 | PFS |
osimertinib ± LCT | Phase II | NCT03410043 (NORTHSTAR) | 143 | PFS |
Brigatinib + LCT | Phase I | NCT03707938 (BRIGHTSTAR) | 35 | Incidence of adverse events |
ipilimumab + nivolumab ± LCT | Phase III | NCT03391869 (LONESTAR) | 360 | OS |
KRAS | |||||
---|---|---|---|---|---|
KRASG12C inhibitors | Drug type | Status | NCT No | Sample size | Primary endpoint |
KRAS inhibitor monotherapy | |||||
Sotorasib | KRAS G12C inhibitor | Phase III | NCT04303780 (CodeBreaK200) | 345 | PFS |
Adagrasib | KRAS G12C inhibitor | Phase III | NCT04685135 (KRYSTAL-12) | 340 | PFS |
JDQ443 | KRAS G12C inhibitor | Phase Ib/II Phase III | NCT04699188 (KontRASt-01) NCT05132075 (KontRASt-02) | 425; 360 | DLT, AE, SAE, dose interruptions and reductions, dose intensity, ORR; PFS |
D-1553 | KRAS G12C inhibitor | Phase I/II | NCT04585035 (D1553-101) NCT05383898 | 200 203 | DLT, AE, Plasma concentration; DLT, AE, ORR |
GDC-6036 | KRAS G12C inhibitor | Phase Ia/b Phase II/III | NCT04449874 (GO42144) NCT03178552 (BFAST-cohort G) | 498 1000 (all cohorts) | AE, DLT; PFS |
Combination with KRAS inhibitors | |||||
Sotorasib + RMC-4630 | KRAS G12C; SHP2 inhibitor | Phase II | NCT05054725 | 46 | ORR |
Sotorasib/Adagrasib + TNO155 | KRAS G12C; SHP2 inhibitor | Phase I/II | NCT04185883 (CodeBreak101) NCT04330664 (KRYSTAL-2) | 1054 (all cohorts) 86 | DLT, TEAE, AE, vital signs, ECG, laboratory test values, ORR; AE, Plasma concentration |
Adagrasib + pembro | KRAS G12C; immune checkpoint inhibitor | Phase II | NCT04613596 (KRYSTAL 7) | 250 | ORR |
Adagrasib + BI1701963 | KRAS G12C; SOS1 inhibitor | Phase I/Ib | NCT04975256 (KRYSTAL 14) | 100 | TRAE, Plasma concentration, DLT |
NTRK | |||||
---|---|---|---|---|---|
TRK inhibitors | Drug type | Status | NCT No | Sample size | Primary endpoint |
Selitrectinib | Next generation TRK inhibitor | Phase I/II | NCT03215511 | 81 (adult and pediatric patients) | MTD, recommended dose, ORR |
Repotrectinib | Next generation TRK /ROS1 inhibitor | Phase I/II | NCT04094610 NCT03093116 (TRIDENT-1) | 75 (adult and pediatric patients); 500 (all arms) | DLT, ORR; DLT, RP2D, ORR |
HER2 | |||||
---|---|---|---|---|---|
HER2 inhibitors | Drug type | Status | NCT No | Sample size | Primary endpoint |
T-DXd | ADC | Phase II Phase III | NCT04644237 (DESTINY-Lung02) NCT05048797 (DESTINY-Lung04) | 150 264 | ORR PFS |
T-DM1 | ADC | Phase II | NCT02675829 | 140 | ORR |
A166 | ADC | Phase I/II | NCT03602079 | 49 | MTD |
Pyrotinib | TKI | Phase III | NCT04447118 (PYRAMID-1) | 150 | PFS |
Poziotinib | TKI | Phase III | NCT05378763 (PINNACLE) | 268 | PFS |
ADC | |||||
---|---|---|---|---|---|
ADC agents | ADC targets | Status | NCT No | Sample size | Primary endpoint |
HER3-DXd | HER3 | Phase II Phase I | NCT04619004 (HERTHENA-Lung01) NCT03260491 | 420 264 | ORR; DLT, AE, ORR, maximum serum concentration, area under the serum concentration–time curve |
ABBV-399 | C-MET | Phase II Phase III | NCT03539536 NCT04928846 | 270 698 | ORR, AE; PFS, OS |
IMMU-132 | TROP-2 | Phase II Phase III | NCT03964727 (TROPICS-03) NCT05089734 | 165 520 | ORR; OS |
DS-1062 | TROP-2 | Phase III | NCT04656652 (TROPION-LUNG01) | 590 | PFS, OS |
SAR408701 | CEACAM5 | Phase III | NCT04154956 (CARMEN-LC03) | 554 | PFS, OS |
SAR408701 + ramucirumab | CEACAM5; Immune checkpoint inhibitor | Phase II | NCT04394624 (CARMEN-LC04) | 36 | DLT, ORR |
SAR408701 + pembro | CEACAM5; Immune checkpoint inhibitor | Phase II | NCT04524689 (CARMEN-LC05) | 120 | DLT |
ICI for oncogene-negative NSCLC | |||||
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PD-1/PD-L1 inhibitor | Drug type | Status | NCT No | Sample size | Primary endpoint |
Atezo + tirago | Anti-PD-L1; anti-TIGIT | Phase III | NCT04294810 (SKYSCRAPER-01) | 635 | PFS, OS |
Pembro + MK-7684a | Anti-PD-1; anti-TIGIT | Phase III | NCT04738487 (MK-7684A-003) | 1246 | OS (stratified by PD-L1 expression) |
Pembro + Eftilagimod alpha | Anti-PD-1; anti-LAG3 | Phase II | NCT03625323 (TACTI-002) | 189 | ORR |
Pembro + Lenvatinib + chemo | Anti-PD-1; anti-VEGF | Phase III | NCT03829319 (LEAP-006) | 726 | DLT, AE, PFS, OS |
Pembro + Lenvatinib | Anti-PD-1; anti-VEGF | Phase III | NCT03976375 (LEAP-008) | 405 | OS, PFS |