Trial Title:
YK-029A as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations
NCT ID:
NCT05767892
Condition:
Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carboplatin
Pemetrexed
Conditions: Keywords:
NSCLC
EGFR
EXON 20ins
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
YK-209A tablet
Description:
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.
Arm group label:
YK-029A Group (Arm A)
Intervention type:
Drug
Intervention name:
Pemetrexed+carboplatin/Cisplatin
Description:
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.
Arm group label:
Platinum-based Chemotherapy Group (Arm B)
Summary:
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.
Detailed description:
The drug being tested in this study is called YK-029A. YK-029A is being tested to
evaluate the efficacy as a first line treatment compare with platinum-based chemotherapy
in the participants with locally advanced or NSCLC whose tumors harbor EGFR exon 20
insertion mutations.
The study will enroll 350 patients. Participants will be randomly assigned to one of the
two treatment groups-YK-029A Group (Arm A) or Platinum-based Chemotherapy Group (Arm B).
The participants will be administered with YK-029A orally in arm A and
pemetrexed/cisplatin or pemetrexed/carboplatin intravenously (IV) in arm B until the
participants experience progressive disease (PD) as assessed by blinded independent
review committee (IRC), intolerable toxicity or another discontinuation criteria.
Participants in the chemotherapy group should not be allowed to cross over to treatment
with YK-029A after IRC-assessed PD is documented. Randomized treatment with YK-029A or
platinum-based chemotherapy may be continued after PD, at the discretion of the
investigator and with the sponsor's approval, if there is still evidence of clinical
benefit.
This multi-center trial will be conducted in China . The overall time to participate in
this study is until 3 years after the last participant is randomized. Participants will
make multiple visits to the clinic and will be followed for survival, subsequent
anticancer therapy, subsequent disease assessment outcome until disease progression on a
subsequent anticancer therapy, and participant-reported health status (EORTC QLQ-C30 and
EORTC QLQ-LC13) for 3 years after the last participant is randomized in the study and 30
days after the last dose of study drug for safety follow-up.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female adult patients (aged 18 years or older).
2. Histologically or cytologically confirmed nonsquamous cell locally advanced not
suitable for definitive therapy, recurrent, or metastatic (Stage IV) NSCLC.
3. Documented epidermal growth factor receptor (EGFR) in-frame exon 20 insertion
mutation assessed by a clinical laboratory improvements amendment (CLIA)-certified
(China sites) or an accredited (outside of the US) local laboratory.
3、The EGFR exon 20 insertion mutation can be either alone or in combination with other
EGFR or human epidermal growth factor receptor 2 (HER2) mutations except EGFR mutations
for which there are approved anti-EGFR tyrosine kinase inhibitors [TKIs] (ie, exon 19
del, L858R, T790M, L861Q, G719X, or S768I, where X is any other amino acid).
4、Adequate tumor tissue available, either from primary or metastatic sites, for central
laboratory confirmation of EGFR exon 20 insertion mutation.
5、At least 1 measurable lesion per RECIST Version 1.1. 6、Life expectancy ≥3 months.
7、Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 8、Adequate
organ and hematologic function as defined by blood transfusions with a recommended >/ 14
day washout period.
Exclusion Criteria:
1. Received prior systemic treatment for locally advanced or metastatic disease,
including local administration, such as intra-pleural injection of anticancer
medication with the exception noted below.
2. Neoadjuvant or adjuvant chemotherapy/immune therapy for Stage I to III or combined
modality chemotherapy/radiation for locally advanced disease is allowed if completed
>6 months before the development of metastatic disease.
3. Received radiotherapy ≤14 days before randomization or has not recovered from
radiotherapy-related toxicities.
4. Received a moderate or strong cytochrome P450 (CYP)3A inhibitor or moderate or
strong CYP3A inducer within 10 days before first dose of YK-029A.
5. Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.
6. Have been diagnosed with another primary malignancy other than NSCLC。
7. Have current spinal cord compression or leptomeningeal disease.
8. Have uncontrolled hypertension. Participants with hypertension should be under
treatment on study entry to control blood pressure.
9. Received a live vaccine within 4 weeks before randomization per Summary of product
characteristics (SmPCs) for pemetrexed, cisplatin, and carboplatin.
10. As judged by the investigator, any evidence of severe or uncontrolled systemic
diseases, including uncontrolled hypertension and active bleeding diatheses (i.e.,
hemophilia and Von Willebrand disease).
Gender:
All
Gender based:
Yes
Gender description:
18 Years and older (Adult, Older Adult)
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Bengbu Medical Colleg
Address:
City:
Bengbu
Zip:
233000
Country:
China
Contact:
Last name:
Chenling Zhao
Facility:
Name:
Anhui Provincial Chest Hospital
Address:
City:
Hefei
Zip:
230000
Country:
China
Contact:
Last name:
Xuhong Min
Facility:
Name:
Anhui Provincial Hospital
Address:
City:
Hefei
Zip:
230000
Country:
China
Contact:
Last name:
Yueyin Pan
Facility:
Name:
Yijishan Hospital of Wannan Medical College
Address:
City:
Wuhu
Zip:
241000
Country:
China
Contact:
Last name:
Zhiwei Lu
Facility:
Name:
Beijing Chest Hospital, Capital Medical University
Address:
City:
Beijing
Zip:
100102
Country:
China
Contact:
Last name:
Zhe Liu
Facility:
Name:
The First Affiliated Hospital of Chongqing Medical University
Address:
City:
Chongqing
Zip:
400000
Country:
China
Contact:
Last name:
Tao Zhang
Facility:
Name:
The Second Affiliated Hospital of Chongqing Medical University
Address:
City:
Chongqing
Zip:
400000
Country:
China
Contact:
Last name:
Zhengzhou Yang
Facility:
Name:
Fujian Provincial Cancer Hospital
Address:
City:
Fuzhou
Zip:
350000
Country:
China
Contact:
Last name:
Yunjian Huang
Facility:
Name:
The First Affiliated Hospital of Xiamen University
Address:
City:
Xiamen
Zip:
361000
Country:
China
Contact:
Last name:
Jinxun Wu
Facility:
Name:
Gansu Provincial Cancer Hospital
Address:
City:
Lanzhou
Zip:
730030
Country:
China
Contact:
Last name:
Lei Yang
Facility:
Name:
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Contact:
Last name:
Minhui Wang
Facility:
Name:
Cancer Hospital Affiliated to Guangzhou Medical University
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Contact:
Last name:
Chuan Jing
Facility:
Name:
The First Affiliated Hospital of Guangdong Pharmaceutical University
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Contact:
Last name:
Xicheng Wang
Facility:
Name:
People's Hospital of Zhongshan City
Address:
City:
Zhongshan
Zip:
528400
Country:
China
Contact:
Last name:
Jiewen Peng
Facility:
Name:
Guizhou Provincial People's Hospital
Address:
City:
Guiyang
Zip:
550000
Country:
China
Contact:
Last name:
Xianwei Ye
Facility:
Name:
The Fourth Hospital of Hebei Medical University
Address:
City:
Shijiazhuang
Zip:
050000
Country:
China
Contact:
Last name:
Yudong Wang
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
150081
Country:
China
Contact:
Last name:
Baogang Liu
Facility:
Name:
he First Affiliated Hospital of Henan University of Science and Technology
Address:
City:
Luoyang
Zip:
471000
Country:
China
Contact:
Last name:
Yeye Zhang
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Contact:
Last name:
Yanqiu Zhao
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhenzhou
Zip:
450000
Country:
China
Contact:
Last name:
Xingya Li
Facility:
Name:
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430000
Country:
China
Contact:
Last name:
Qian Chu
Facility:
Name:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430000
Country:
China
Contact:
Last name:
Xiaorong Tong
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410000
Country:
China
Contact:
Last name:
Lin Wu
Facility:
Name:
Third Xiangya Hospital, Central South University
Address:
City:
Changsha
Zip:
410000
Country:
China
Contact:
Last name:
Xuewen Liu
Facility:
Name:
Affiliated Hospital of Inner Mongolia Medical University
Address:
City:
Hohhot
Zip:
010000
Country:
China
Contact:
Last name:
Junzhen Gao
Facility:
Name:
Jiangsu Province Hospital
Address:
City:
Nanjing
Zip:
210000
Country:
China
Contact:
Last name:
Renhua Guo
Facility:
Name:
The Second Affiliated Hospital of Soochow Universit
Address:
City:
Suzhou
Zip:
215000
Country:
China
Contact:
Last name:
Zhixiang Zhuang
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330000
Country:
China
Contact:
Last name:
Longhua Sun
Facility:
Name:
The Second Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330000
Country:
China
Contact:
Last name:
Xiaoqun Ye
Facility:
Name:
Jiangxi Cancer Hospital
Address:
City:
Nanchang
Zip:
l330000
Country:
China
Contact:
Last name:
Hui Luo
Facility:
Name:
Jilin Provincial Cancer Hospital
Address:
City:
Changchun
Zip:
130000
Country:
China
Contact:
Last name:
Yin Chen
Facility:
Name:
he First Affiliated Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110000
Country:
China
Contact:
Last name:
Mingfang Zhao
Facility:
Name:
Cancer Hospital Affiliated to Shandong First Medical University
Address:
City:
Jinan
Zip:
250000
Country:
China
Contact:
Last name:
Haiyong Wang
Facility:
Name:
Qilu Hospital of Shandong University
Address:
City:
Jinan
Zip:
250000
Country:
China
Contact:
Last name:
Lian Liu
Facility:
Name:
Affiliated Hospital of Jining Medical University
Address:
City:
Jining
Zip:
272000
Country:
China
Contact:
Last name:
Shuchen Ye
Facility:
Name:
The Affiliated Hospital of Qingdao University
Address:
City:
Qingdao
Zip:
266000
Country:
China
Contact:
Last name:
Helei Lou
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
Shanghai
Zip:
200000
Country:
China
Contact:
Last name:
Peng Zhang
Facility:
Name:
Shanxi Cancer Hospital
Address:
City:
Taiyuan
Zip:
030000
Country:
China
Contact:
Last name:
Jianchun Duan
Facility:
Name:
the First Affiliated Hospital; Medical College of Xi'an Jiaotong University
Address:
City:
Xian
Zip:
710000
Country:
China
Contact:
Last name:
Yu Y
Facility:
Name:
The Second Affiliated Hospital of PLA Air Force Medical University
Address:
City:
Xian
Zip:
710000
Country:
China
Contact:
Last name:
Haichuan Su
Facility:
Name:
Sichuan Provincial People's Hospital
Address:
City:
Chengdu
Zip:
610000
Country:
China
Contact:
Last name:
Ke Xie
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Chengdu
Zip:
610000
Country:
China
Contact:
Last name:
Dan Liu
Facility:
Name:
Tianjin Cancer Hospital
Address:
City:
Tianjin
Zip:
300000
Country:
China
Contact:
Last name:
Dingzhi Huang
Facility:
Name:
Yunnan Cancer Hospital
Address:
City:
Kunming
Zip:
650000
Country:
China
Contact:
Last name:
Runxiang Yang
Facility:
Name:
Cancer in Zhejiang Province
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Contact:
Last name:
Yun Fan
Facility:
Name:
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Contact:
Last name:
Y Fang
Facility:
Name:
The First Affiliated Hospital of Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Contact:
Last name:
Jianya Zhou
Facility:
Name:
Taizhou First People's Hospital
Address:
City:
Taizhou
Zip:
318000
Country:
China
Contact:
Last name:
Lili Chen
Facility:
Name:
Taizhou Hospital of Zhejiang Province
Address:
City:
Taizhou
Zip:
318000
Country:
China
Contact:
Last name:
Youzu Xu
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
10000
Country:
China
Contact:
Last name:
Li Zhang
Facility:
Name:
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Address:
City:
Beijing
Zip:
100102
Country:
China
Contact:
Last name:
Jie Wang, Doctor
Investigator:
Last name:
Jie Wang, Doctor
Email:
Principal Investigator
Investigator:
Last name:
Chunjian Duan, Doctor
Email:
Sub-Investigator
Facility:
Name:
Peking University Cancer Hospital
Address:
City:
Beijing
Zip:
100102
Country:
China
Contact:
Last name:
Jun Zhao, Doctor
Start date:
May 1, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Suzhou Puhe Pharmaceutical Technology Co., LTD
Agency class:
Industry
Source:
Suzhou Puhe Pharmaceutical Technology Co., LTD
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05767892
