YK-029A as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

May 1, 2023

Primary Completion Date

July 30, 2025

Study Completion Date

December 31, 2026

Conditions
Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
Interventions
DRUG

YK-209A tablet

YK-029A 200 milligram (mg) , orally without food,once daily until the participants experience PD as assessed by blinded IRC, intolerable toxicity, or another discontinuation criteria.

DRUG

Pemetrexed+carboplatin/Cisplatin

Participants randomized into chemotherapy arm can receive up to 6 cycles of pemetrexed + carboplatin (pemetrexed 500 mg/m2 + carboplatin area under the plasma concentration-time curve 5 mg/ml per minute (AUC5), IV infusion, every 3 weeks) as the initial treatment. Participants whose disease has not progressed after 4 cycles of first-line platinum-based doublet chemotherapy may receive pemetrexed maintenance monotherapy until a treatment discontinuation criterion is met.

Trial Locations (52)

10000

Peking Union Medical College Hospital, Beijing

100102

Beijing Chest Hospital, Capital Medical University, Beijing

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing

Peking University Cancer Hospital, Beijing

110000

he First Affiliated Hospital of China Medical University, Shenyang

130000

Jilin Provincial Cancer Hospital, Changchun

150081

Harbin Medical University Cancer Hospital, Harbin

200000

Shanghai Pulmonary Hospital, Shanghai

210000

Jiangsu Province Hospital, Nanjing

215000

The Second Affiliated Hospital of Soochow Universit, Suzhou

230000

Anhui Provincial Chest Hospital, Hefei

Anhui Provincial Hospital, Hefei

233000

The First Affiliated Hospital of Bengbu Medical Colleg, Bengbu

241000

Yijishan Hospital of Wannan Medical College, Wuhu

250000

Cancer Hospital Affiliated to Shandong First Medical University, Jinan

Qilu Hospital of Shandong University, Jinan

266000

The Affiliated Hospital of Qingdao University, Qingdao

272000

Affiliated Hospital of Jining Medical University, Jining

300000

Tianjin Cancer Hospital, Tianjin

310000

Cancer in Zhejiang Province, Hangzhou

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou

The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou

318000

Taizhou First People's Hospital, Taizhou

Taizhou Hospital of Zhejiang Province, Taizhou

330000

The First Affiliated Hospital of Nanchang University, Nanchang

The Second Affiliated Hospital of Nanchang University, Nanchang

350000

Fujian Provincial Cancer Hospital, Fuzhou

361000

The First Affiliated Hospital of Xiamen University, Xiamen

400000

The First Affiliated Hospital of Chongqing Medical University, Chongqing

The Second Affiliated Hospital of Chongqing Medical University, Chongqing

410000

Hunan Cancer Hospital, Changsha

Third Xiangya Hospital, Central South University, Changsha

430000

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

450000

Henan Cancer Hospital, Zhengzhou

The First Affiliated Hospital of Zhengzhou University, Zhenzhou

471000

he First Affiliated Hospital of Henan University of Science and Technology, Luoyang

510000

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou

510080

Cancer Hospital Affiliated to Guangzhou Medical University, Guangzhou

The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou

528400

People's Hospital of Zhongshan City, Zhongshan

550000

Guizhou Provincial People's Hospital, Guiyang

610000

Sichuan Provincial People's Hospital, Chengdu

West China Hospital, Sichuan University, Chengdu

650000

Yunnan Cancer Hospital, Kunming

710000

the First Affiliated Hospital; Medical College of Xi'an Jiaotong University, Xian

The Second Affiliated Hospital of PLA Air Force Medical University, Xian

730030

Gansu Provincial Cancer Hospital, Lanzhou

050000

The Fourth Hospital of Hebei Medical University, Shijiazhuang

010000

Affiliated Hospital of Inner Mongolia Medical University, Hohhot

l330000

Jiangxi Cancer Hospital, Nanchang

030000

Shanxi Cancer Hospital, Taiyuan

All Listed Sponsors
lead

Suzhou Puhe Pharmaceutical Technology Co., LTD

INDUSTRY

NCT05767892 - YK-029A as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations | Biotech Hunter | Biotech Hunter