The main PD-1/PD-L1 inhibitors approved by the FDA for use in NSCLC are Pembrolizumab (by Merck Sharp & Dohme), Nivolumab (by Bristol-Myers Squibb), Atezolizumab (by Roche), Durvalumab (by AstraZeneca), all of which currently have studies recruiting Chinese patients are underway.
In addition, studies are underway with domestic PD-1/PD-L1 inhibitors (none of which have been approved for marketing) produced by Cinda Biologics, Hengrui Pharmaceuticals, Baxi Shenzhou, Junshi Biologics, and Zhengda Tianqing.
The following table summarizes the PD-1/PD-L1 inhibitor clinical trials currently underway in patients with NSCLC and small cell lung cancer, based on information from the China Drug Clinical Trials Registry and Information Disclosure Platform. It is important to note that this information is dynamically updated, so please refer to the information obtained by consulting your doctor.
To participate in a clinical trial for PD-1/PD-L1 inhibitor therapy, you will need to talk to your primary care physician, who will determine if you are eligible for enrollment and help you apply.
| Table 1: Clinical trials related to PD-1 inhibitors | ||
| Drugs | Registration number | Indication and study status |
|
Nivolumab (BMS) |
CTR20170731 |
Treated advanced or recurrent solid tumors; stage III; not yet recruited |
| CTR20170694 | Extensive stage small cell lung cancer; stage III; recruiting | |
|
CTR20170541 |
Advanced or metastatic NSCLC; stage III; recruiting |
|
|
CTR20170340 |
NSCLC; stage III; recruiting | |
| CTR20160578 | Limited or extensive stage small cell lung cancer; stage III; enrollment complete | |
| CTR20150767 | Advanced or metastatic NSCLC; stage III; enrollment complete | |
| CTR20171020 |
NSCLC; recruiting in progress |
|
| CTR20150755 | Advanced or recurrent solid tumors; not yet recruited | |
|
Pembrolizumab (Merck Sharp & Dohme) |
CTR20170044 | Metastatic squamous NSCLC; stage III; recruiting |
| CTR20160205 |
NSCLC with disease progression after platinum-containing therapy and positive PD-L1 expression; recruitment in progress |
|
| CTR20160097 |
Advanced or metastatic NSCLC with positive PD-L1 expression and primary treatment; recruitment complete |
|
|
SHR-1210 (Hengrui) |
CTR20170322 |
Advanced NSCLC; stage III; recruiting |
|
CTR20170299 |
Advanced NSCLC; stage II; recruiting |
|
| CTR20170090 | Combination of Apatinib for Advanced NSCLC; Phase II; Recruiting | |
| CTR20160248 |
Solid Tumors; Stage I; Recruiting |
|
| CTR20160175 | Advanced Solid Tumors; Stage I; Recruiting | |
|
IBI308 (Cinda) |
CTR20160735 | Solid Tumors; Stage I; Recruiting |
|
CTR20170380 |
Advanced or metastatic squamous NSCLC; recruitment in progress | |
|
BGB-A317 (Baekje Shenzhou) |
CTR20171112 |
NSCLC; recruiting in progress |
| CTR20170361 |
Lung cancer; recruitment in progress |
|
|
CTR20160871 |
Solid tumors; stage I-II; recruiting | |
|
JS001 (Junsit) |
CTR20180275 | Advanced NSCLC; recruiting |
| CTR20160274 | Advanced or recurrent malignancy; stage I; recruiting | |
| Table 2: Clinical trials related to PD-L1 inhibitors | ||
| Drugs | Registration number | indications and study status |
|
Atezolizumab (Roche) |
CTR20171629 | Primarily treated advanced or recurrent or metastatic NSCLC; not yet recruited |
| CTR20170064 | Stage IV non-squamous NSCLC not previously treated with chemotherapy; stage III; recruiting | |
| CTR20160988 | Extensive Stage Small Cell Lung Cancer; Stage III; Recruiting | |
|
Durvalumab (AstraZeneca) |
CTR20170012 | Advanced NSCLC; stage III; recruiting |
|
TQB2450 (CZT) |
CTR20180272 | Advanced malignancy; stage I; not yet recruited |
|
KN035 (Thoughtfulness/Corning Jerry) |
CTR20170036 | Advanced Solid Tumors; Stage I; Recruiting |
(Note: BMS, Bristol-Myers Squibb; TKI, tyrosine kinase inhibitor)
Hospitals and trial leaders primarily undertaking these trials include: Yilong Wu, Guangdong Provincial People’s Hospital; Tension, Center for Cancer Control, Sun Yat-sen University; Ying Cheng, Jilin Provincial Cancer Hospital; Yuankai Shi, Cancer Hospital, Chinese Academy of Medical Sciences; Cai-cun Zhou, Shanghai Pulmonary Hospital; and Shun Lu, Shanghai Chest Hospital.
Note: Drug Clinical Trial Registration and Information Disclosure Platform; http://www.chinadrugtrials.org.cn/eap/main
Co-reviewed by: Guangdong Provincial People’s Hospital Guangdong Lung Cancer Institute Dr. Wang Zhen, Deputy Chief Physician Liu Siyang