Table 6 Summary of phase I/II clinical trials for advanced/metastatic NSCLC
From: Emerging therapeutic agents for advanced non-small cell lung cancer
Drug Class | Drug | Mechanism of action | Study design | Clinical trial | Phase | Type of cancer | Status |
|---|---|---|---|---|---|---|---|
Targeted therapy | Ensartinib | ALK inhibitor | Monotherapy | NCT03215693 | I | NSCLC | Recruiting |
Ensartinib | ALK inhibitor | Monotherapy | NCT01625234 | I/II | NSCLC | Recruiting | |
Repotrectinib (TPX-0005) | ALK/ROS1/NTRK inhibitor | Monotherapy | NCT03093116 | I | ALK/ROS1/NTRK+ solid tumors | Recruiting | |
M6620 (VX-970) | ATR inhibitor | Combination with gemcitabine | NCT02157792 | I | NSCLC | Active, not recruiting | |
Bemcentinib | AXL inhibitor | Combination with docetaxel | NCT02922777 | I/II | NSCLC | Recruiting | |
Bemcentinib | AXL inhibitor | Combination with pembrolizumab | NCT03184571 | II | NSCLC | Recruiting | |
TP-0903 | AXL inhibitor | Monotherapy | NCT02729298 | I | Advanced solid tumors | Recruiting | |
Nazartinib | EGFR | Monotherapy | NCT02108964 | II | EGFRmut solid tumors | Active, not recruiting | |
BPI-7711 | EGFR 790 M inhibitor | Monotherapy | NCT03386955 | I | NSCLC | Recruiting | |
TAK-788 | EGFR and HER2 TKI including exon 20 insertions | Monotherapy | NCT02716116 | I/II | NSCLC | Recruiting | |
YH25448 | EGFR and T790M | Monotherapy | NCT03046992 | I/II | NSCLC | Recruiting | |
HS-10296 | EGFR inhibitor | Monotherapy | NCT02981108 | I/II | NSCLC | Recruiting | |
SPH1188-11 | EGFR inhibitor | Monotherapy | NCT03231475 | I | NSCLC | Recruiting | |
Poziotinib | EGFR or HER2 exon 20 inhibitor | Monotherapy | NCT03318939 | II | NSCLC | Recruiting | |
Pyrotinib | HER1/HER2/HER4 inhibitor | Monotherapy | NCT02834936 | I | NSCLC | Unknown | |
AMG510 | KRAS G21C inhibitor | Monotherapy | NCT03600883 | I/II | KRAS g12C mutation solid tumors | Recruiting | |
MRTX849 | KRAS G21C inhibitor | Monotherapy | NCT03785249 | I/II | KRAS g12C mutation solid tumors | Recruiting | |
Capmatinib (INC280) | MET inhibitor | Monotherapy and in combination with gefitinib | NCT02468661 | I | NSCLC | Recruiting | |
Tepotinib | MET inhibitor | Monotherapy | NCT02864992 | II | NSCLC | Recruiting | |
LOXO-292 | RET inhibitor | Monotherapy | NCT03157128 | I | RET (+) cancers | Recruiting | |
DS-6051b | ROS1/NTRK inhibitor | Monotherapy | NCT02279433 | I | ROS1 and NTRK Advanced carcinoma | Active, not recruiting | |
MP0250 | VEGF and HGF neutralizing DARPIN molecule | Monotherapy | NCT02194426 | I | Advanced solid tumors | Completed | |
Antibody-drug conjugate | PF-7020 | ADC targeting protein tyrosine kinase 7 (PTK7) | Monotherapy | NCT02222922 | I | Advanced solid tumors | Active, not recruiting |
BA3011 | Anti-AXL antibody | Monotherapy | NCT03425279 | I/II | Advanced solid tumors | Recruiting | |
EnaV | Anti-AXL antibody | Monotherapy | NCT02988817 | I/II | Advanced solid tumor | Recruiting | |
U3-1403 | Anti-HER2 antibody-drug conjugate | Monotherapy | NCT03260491 | I | NSCLC | Recruiting | |
Anetumab | Anti-mesothelin IgG1 antibody conjugated to the maytansinoid tubulin inhibitor DM4 | Monotherapy or in combination | NCT03102320 | I | Advanced solid tumors | Recruiting | |
BT1718 | Bicycle drug conjugate, binds MT1-MMP and linked to DM1 | Monotherapy | NCT03486730 | I/II | Advanced solid tumors | Recruiting | |
JNJ-372 | EGFR-cMet bispecific antibody | Monotherapy | I | NSCLC | Recruiting | ||
XMT-1522 | HER-2 Targeting antibody-drug conjugate | Monotherapy | NCT02952729 | I | Her 2 expressing breast, lung, and gastric cancer | Active, not recruiting | |
DS-1062a | TROP2-targeting antibody-drug conjugate | Monotherapy | NCT03401385 | I | Advanced solid tumors | Recruiting | |
DS-8201a | HER-2 Targeting antibody-drug conjugate | Monotherapy | NCT02564900 | I | HER2 expression solid tumors | Active, not recruiting | |
Cell therapy | MAGE-A10 T cell therapy | Affinity-enhanced T cells against MAGE A10 antigen | Monotherapy | NCT02592577/NCT02989064 | I | Advanced solid tumors | Recruiting |
CRISP/Cas9-mediated knockout of PD-1 gene | T lymphocytes with PD-1 gene knockout | Monotherapy | NCT02793856 | I | NSCLC | Active, not recruiting | |
Cytokine therapy | ALT-803 | IL-15 superagonist | Combination with nivolumab | NCT02523469 | I/II | NSCLC | Active, not recruiting |
Immuno-Conjugate | L-DOS47 | Urease immuno-conjugate | Combination with cisplatin+vinorolbine | NCT03891173 | I/II | NSCLC | Recruiting |
Immuno-Conjugate | L-DOS47 | Urease immuno-conjugate | Combination with carbo+pemetrexed | NCT02309892 | I/II | NSCLC | Recruiting |
Immunotherapy | NIR178 | A2AR antagonist | Monotherapy | NCT02403193 | I/II | NSCLC | Recruiting |
PBF-1129 | Anti-A2aR | Monotherapy | NCT03274479 | I | NSCLC | Recruiting | |
AB928 and AB122 | Anti-A2aR and A2bR, Anti-PD-1 | Monotherapy and combination therapies | NCT03846310 | I | NSCLC | Recruiting | |
REGN4659 | Anti-CTLA-4 | Combination with cemiplimab | NCT03580694 | I | NSCLC | Recruiting | |
BMS-986253 (HuMax-IL8) | Anti-IL-8 monoclonal antibody | Monotherapy | NCT02536469 | I | Advanced solid tumors | Completed | |
MSC-1 | Anti-leukemia inhibitory factor(LIF) antibody | Monotherapy | NCT03490669 | I | Advanced solid tumors | Active, not recruiting | |
Cemiplimab | Anti-PD-1 | Monotherapy | NCT02383212 | I | Advanced malignancies | Active, not recruiting | |
JS001 | Anti-PD-1 | Monotherapy | NCT02836834 | I | Advanced or recurrent malignancies | Active, not recruiting | |
PDR001 | Anti-PD-1 | Combination with platinum doublet | NCT03064854 | I | NSCLC | Recruiting | |
SHR-1210 | Anti-PD-1 | Combination with apatinib | NCT03083041 | I/II | NSCLC | Unknown | |
Tislelizumab | Anti-PD-1 | Combination with chemotherapy | NCT03432598 | II | NSCLC | Recruiting | |
NC318 | Siglec-15 antibody | Monotherapy | NCT03665285 | I | Advanced solid tumors | Recruiting | |
TSR-022,TSR 042, TSR033 | Anti-TIM-3, Anti-PD-1, and anti-LGA3 | Monotherapy and in Combination | NCT02817633 | I | Advanced tumor | Recruiting | |
Eftilagimod alpha | LAG-3 fusion protein | Combination with pembrolizumab | NCT03625323 | II | NSCLC and HNSCC | Recruiting | |
NKTR-214 | CD122-biased agonist | Combination with nivolumab | NCT02983045 | I/II | Advanced cancers | Recruiting | |
NKTR-214 | CD122-Biased Cytokine | Combination with pembrolizumab or atezolizumab | NCT03138889 | I | NSCLC | Recruiting | |
APX005M | CD40 agonistic antibody | Combination with nivolumab | NCT03123783 | I/II | NSCLC | Recruiting | |
SEA-CD40 | CD40 Antibody | Monotherapy and in Combination with pembrolizumab | NCT02376699 | I | Relapsed/refractory metastatic solid tumors | Recruiting | |
ALX148 | CD47 blocker | Monotherapy and combination with pembrolizumab, trastuzumab, or rituximab | NCT03013218 | I | Advanced solid tumors and lymphoma | Recruiting | |
IO102 | IDO vaccine | Combination with pembrolizumab with or without chemotherapy | NCT03562871 | I/II | NSCLC | Recruiting | |
Epacadostat | IDO1 inhibitor | Combination with pembrolizumab | NCT02178722 | I/II | Solid tumors | Active, not recruiting | |
BI1361849 | mRNA vaccine | Combination with durvalumab and/or tremelimumab | NCT03164772 | I/II | NSCLC | Recruiting | |
EVAX-01-CAF09b | Neo-antigen vaccine | Montherapy | NCT03715985 | I | Advanced solid tumors | Recruiting | |
NEO-PV-01 | Personal neoantigen vaccine | Combination with pembrolizumab +chemotherapy | NCT03380871 | I | NSCLC | Active, not Recruiting | |
ADXS-NEO | Personalized neoantigen-listeria vaccine | Monotherapy and combination with pembrolizumab | NCT03265080 | I | Advanced tumor | Recruiting | |
LYC-55716 | RORγ agonist | Combination with pembrolizumab | NCT03396497 | I | NSCLC | Active, not recruiting | |
LN-144/LN-145 | Tumor-infiltrating lymphocytes | Monotherapy and combination with pembrolizumab | NCT03645928 | II | NSCLC | Recruiting | |
CV301 | Vaccine | Combination with pembrolizumab | NCT02840994 | I | NSCLC | Active, not recruiting | |
DCVAC | Vaccine | Combination with chemotherapy | NCT02470468 | I/II | NSCLC | Active, not recruiting | |
UCPVax | Vaccine | Montherapy | NCT02818426 | I/II | NSCLC | Recruiting | |
Debio 1143 | Smac mimetics | Combination with avelumab | NCT03270176 | I | NSCLC | Recruiting | |
Tumor epigenetics | ACY 241 | HDAC inhibitors | Combination with nivolumab | NCT02635061 | I | NSCLC | Recruiting |
PLX51107 | BET inhibitor | Monotherapy | NCT02683395 | Ib/IIa | advanced hematological and solid tumors | Terminated | |
Entinostat | HDAC inhibitors | Combination with pembrolizumab | NCT02437136 | I/II | NSCLC | Active, not recruiting | |
Vorinostat | HDAC inhibitors | Combination with pembrolizumab | NCT02638090 | I/II | NSCLC | Recruiting |