Table 1.
Ongoing clinical trials of tyrosine kinase inhibitors for lung cancer in China
| Agents | Location(s) | Identifier | Phase | PI in China | Indication | Intervention/content | Status in China |
|---|---|---|---|---|---|---|---|
| Targeting EGFR pathway | |||||||
| Afatinib | I | NCT01953913 | 3 | Yi-long Wu | Without history of EGFR TKI treatment | Afatinib efficacy in NSCLC with EGFR mutation(s) | Recruiting |
| Icotinib | D | NCT02714010 | 3 | Li-kun Chen | Without history of EGFR TKI treatment | WBI concurrent with EGFR TKI vs EGFR TKI | Recruiting |
| Epitinib | D | NCT02590952 | 1 | Yi-long Wu | Without history of EGFR TKI treatment/developed brain lesions during TKI therapy | Pharmacokinetics, safety, and tolerability in solid tumors | Recruiting |
| Hemay020 | D | NCT02467569 | 1 | Hai-ying Wu | Second-line and beyond | Pharmacokinetics, safety, and tolerability in solid tumors | Recruiting |
| Targeting T790M pathway | |||||||
| Osimertinib | I | NCT02296125 | 3 | Yi-long Wu | First-line | Osimertinib vs EGFR TKI in advanced NSCLC | Active, not recruiting |
| Avitinib | D | NCT02330367 | 1/2 | Yi-long Wu | Second-line and beyond | Safety, tolerability, pharmacokinetics, and efficacy in T790M-positive advanced NSCLC | Recruiting |
| Alflutinib | D | NCT02973763 | 1 | Yuan-kai Shi | Second-line and beyond | Pharmacokinetics, safety, and tolerability in NSCLC after progression on prior EGFR TKI | Not yet recruiting |
| Targeting HER2 pathway | |||||||
| Afatinib | I | NCT02597946 | 2 | Cai-cun Zhou | Second-line and beyond | Efficacy in HER2 mutation NSCLC after chemotherapy | Recruiting |
| Pyrotinib | D | NCT02535507 | 2 | Cai-cun Zhou | Third-line and beyond | Efficacy in HER2 mutation advanced NSCLC | Recruiting |
| Allitinib | D | CTR20150258 | 2 | Yi-long Wu | Second-line and beyond | Safety and efficacy in uncommon EGFR mutant or HER2 mutation/amplification NSCLC | Recruiting |
| Targeting ALK pathway | |||||||
| Alectinib | I | NCT02838420 | 3 | Cai-cun Zhou | First-line | Alectinib vs crizotinib in Asian patients NSCLC | Recruiting |
| CT-707 | D | NCT02695550 | 1 | Yuan-kai Shi | Second-line and beyond | Pharmacokinetics, safety, and tolerability in ALK-positive NSCLC | Recruiting |
| Ensartinib | D | NCT02959619 | 1 | Li Zhang | Without history of ALK TKI treatment except crizotinib | Pharmacokinetics, safety, and tolerability in ALK-positive NSCLC | Not yet recruiting |
| SAF-189s | D | CTR20160340 | 1/2 | Yi-long Wu | Second-line and beyond | Safety, tolerability, pharmacokinetics, and efficacy in ALK-positive NSCLC | Recruiting |
| Targeting c-MET pathway | |||||||
| INC280 | I | NCT02276027 | 2 | Yi-long Wu | Without history of c-MET TKI treatment | INC280 in NSCLC with c-MET gene alteration | Recruiting |
| Volitinib | D | NCT02374645 | 1 | Jin-ji Yang | Second-line | Volitinib in combination with gefitinib in EGFR-mutated, c-MET-alternated NSCLC after progress on EGFR TKI | Recruiting |
| Bozitinib | D | NCT02896231 | 1 | Yi-long Wu | Without history of c-MET/HGF inhibitor treatment | Safety, tolerability, and pharmacokinetics in MET-positive advanced NSCLC | Recruiting |
| BPI-9016M | D | NCT02929290 | 1 | Yuan-kai Shi | Second-line and beyond | Safety, efficacy, and pharmacokinetics in c-MET dysregulated advanced NSCLC | Not yet recruiting |
| Targeting VEGFR pathway | |||||||
| Fruquintinib | D | NCT02976116 | 2 | Jian-ying Zhou | First-line | Fruquintinib in combination with gefitinib in non-squamous NSCLC with activating EGFR mutation | Recruiting |
| NCT02691299 | 2 | Jian-ying Zhou | Third-line | Placebo-controlled in advanced non-squamous NSCLC | Recruiting | ||
| Apatinib | D | NCT02824458 | 3 | Hong-yun Zhao | First-line | Gefitinib in combination with apatinib or placebo in EGFR mutation-positive advanced non-squamous NSCLC | Recruiting |
| NCT02332512 | 3 | Li Zhang | Third/fourth-line | Apatinib in advanced non-squamous NSCLC harboring wild-type EGFR | Recruiting | ||
| Famitinib | D | NCT02766140 | 3 | Cai-cun Zhou | Second-line | Famitinib plus docetaxel compared to placebo plus docetaxel in advanced or metastatic or recurrent non-squamous NSCLC | Recruiting |
| Endostar | D | NCT02001168 | 3 | Zuo-liang Pang | Postoperative adjuvant | Comparison of postoperative adjuvant chemotherapy with/without Rh-endostat in phase Ib NSCLC | Active, not recruiting |
| Anlotinib | D | NCT03059797 | 2 | Ying Cheng | Third-line and beyond | Compare the efficacy and safety of anlotinib vs placebo in SCLC | Recruiting |
| Targeting RET pathway | |||||||
| Apatinib | D | NCT02540824 | 2 | Cai-cun Zhou | Second-line and beyond | Efficacy and safety of apatinib as a single agent in RET fusion gene-positive NSCLC | Recruiting |
| NCT02780778 | 2/3 | Zhan-yu Pan | Second-line | Apatinib plus docetaxel in advanced non-squamous NSCLC | Recruiting | ||
| Targeting ROS-1 pathway | |||||||
| Crizotinib | I | NCT01945021 | 2 | Jin-ji Yang | First-line or no more than third-line treatment | Safety and efficacy of crizotinib in East Asian patients with ROS1-positive, ALK-negative advanced NSCLC | Active, not recruiting |
| Apatinib | D | NCT03164694 | 2 | Si-yu Wang | First-line | Apatinib plus chemotherapy vs chemotherapy in ROS1 gene rearrangement advanced NSCLC | Recruiting |
| Targeting BRAF pathway | |||||||
| BGB-283 | D | CTR20150575 | 1 | Lin-Shen | Second-line and beyond | Pharmacokinetics, safety, and tolerability in advanced solid tumor | Recruiting |
EGFR epidermal growth factor receptor, ALK anaplastic lymphoma kinase, HER2 human epidermal growth factor receptor-2, MET mesenchymal epithelial transition, VEGFR vascular endothelial growth factor receptor, PI principal investigator, I international, D domestic