YK-029A as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations
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
1 other identifier
interventional
350
1 country
52
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2023
Typical duration for phase_3
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2023
CompletedFirst Posted
Study publicly available on registry
March 14, 2023
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedApril 5, 2023
March 1, 2023
2.2 years
March 1, 2023
April 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (8)
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.
- +3 more secondary outcomes
Study Arms (2)
YK-029A Group (Arm A)
EXPERIMENTALPlatinum-based Chemotherapy Group (Arm B)
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- Male or female adult patients (aged 18 years or older).
- Histologically or cytologically confirmed nonsquamous cell locally advanced not suitable for definitive therapy, recurrent, or metastatic (Stage IV) NSCLC.
- 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.
- 、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).
- 、Adequate tumor tissue available, either from primary or metastatic sites, for central laboratory confirmation of EGFR exon 20 insertion mutation.
- 、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.
You may not qualify if:
- 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.
- 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.
- Received radiotherapy ≤14 days before randomization or has not recovered from radiotherapy-related toxicities.
- 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.
- Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.
- Have been diagnosed with another primary malignancy other than NSCLC。
- Have current spinal cord compression or leptomeningeal disease.
- Have uncontrolled hypertension. Participants with hypertension should be under treatment on study entry to control blood pressure.
- Received a live vaccine within 4 weeks before randomization per Summary of product characteristics (SmPCs) for pemetrexed, cisplatin, and carboplatin.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
The 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
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hui Zhao, Doctor
Puhe Biopharma
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2023
First Posted
March 14, 2023
Study Start
May 1, 2023
Primary Completion
July 30, 2025
Study Completion (Estimated)
December 31, 2026
Last Updated
April 5, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share