A Randomized Phase 3 Multicenter Open-Label Study to Compare the Efficacy of YK-029A as First-Line Treatment Versus Platinum-Based Chemotherapy in Patients With Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations
Sponsor study identifier
interventional
350
1 country
52
Study Start
May 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The purpose of this study is to compare the effectiveness of YK-029A as first-line treatment with that of platinum-based chemotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors has epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Participants will be randomly assigned to one of the two treatment groups YK-029A group or Platinum-based chemotherapy group. Participants will receive YK-029A orally and pemetrexed/cisplatin or pemetrexed/carboplatin via vein until the participants experience worsening disease (PD) as assessed by blinded independent review committee (IRC), intolerable harmful effects or another discontinuation criteria.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2023
Actual (reported)March 14, 2023
Actual (reported)May 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Progression Free Survival (PFS) as Assessed by Blinded Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 .
PFS is defined as the time interval from the date of randomization until the first date at which the criteria for progressive disease (PD) according to RECIST Version 1.1 are met or death, whichever occurs first.
Up to approximately 36 months after the first participant is randomized.
Confirmed Objective Response Rate (ORR) as Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1
Up to approximately 36 months after the first participant is randomized.
Overall Survival (OS)
Up to approximately 36 months after the first participant is randomized.
Progression Free Survival (PFS) as Assessed by the Investigator
Up to approximately 36 months after the first participant is randomized.
Confirmed Objective Response Rate (ORR) as Assessed by the Investigator
Up to approximately 36 months after the first participant is randomized.
Duration of Response, as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator.
Up to approximately 36 months after the first participant is randomized.
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.
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.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Pemetrexed+carboplatin/Cisplatin
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordThe First Affiliated Hospital of Bengbu Medical Colleg
Bengbu, Anhui, 233000, China
Anhui Provincial Chest Hospital
Hefei, Anhui, 230000, China
Anhui Provincial Hospital
Hefei, Anhui, 230000, China
Yijishan Hospital of Wannan Medical College
Wuhu, Anhui, 241000, China
Hui Zhao, Doctor
Puhe Biopharma
First Submitted
March 1, 2023
First Posted
March 14, 2023
Study Start
May 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, 100102, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000, China
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350000, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730030, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
Cancer Hospital Affiliated to Guangzhou Medical University
Guangzhou, Guangdong, 510080, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, 510080, China
People's Hospital of Zhongshan City
Zhongshan, Guangdong, 528400, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550000, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
he First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
The First Affiliated Hospital of Zhengzhou University
Zhenzhou, Henan, 450000, China
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
Hunan Cancer Hospital
Changsha, Hunan, 410000, China
Third Xiangya Hospital, Central South University
Changsha, Hunan, 410000, China
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010000, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210000, China
The Second Affiliated Hospital of Soochow Universit
Suzhou, Jiangsu, 215000, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, l330000, China
Jilin Provincial Cancer Hospital
Changchun, Jilin, 130000, China
he First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110000, China
Cancer Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250000, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250000, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272000, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200000, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030000, China
the First Affiliated Hospital; Medical College of Xi'an Jiaotong University
Xian, Shanxi, 710000, China
The Second Affiliated Hospital of PLA Air Force Medical University
Xian, Shanxi, 710000, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610000, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610000, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300000, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650000, China
Cancer in Zhejiang Province
Hangzhou, Zhejiang, 310000, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
Taizhou First People's Hospital
Taizhou, Zhejiang, 318000, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 318000, China
Peking Union Medical College Hospital
Beijing, 10000, China
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, 100102, China
Peking University Cancer Hospital
Beijing, 100102, China
July 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 5, 2023
Record last verified: 2023-03
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Source: ClinicalTrials.gov.
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