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NCT05767892

PHASE3

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

Sponsor: Suzhou Puhe Pharmaceutical Technology Co., LTD

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2023-05-01

Completion Date

2026-12-31

Last Updated

2023-04-05

Healthy Volunteers

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.

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).

Locations (52)

The First Affiliated Hospital of Bengbu Medical Colleg

Bengbu, Anhui, China

Anhui Provincial Chest Hospital

Hefei, Anhui, China

Anhui Provincial Hospital

Hefei, Anhui, China

Yijishan Hospital of Wannan Medical College

Wuhu, Anhui, China

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Gansu Provincial Cancer Hospital

Lanzhou, Gansu, China

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

Guangzhou, Guangdong, China

Cancer Hospital Affiliated to Guangzhou Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, Guangdong, China

People's Hospital of Zhongshan City

Zhongshan, Guangdong, China

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

he First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhenzhou, Henan, China

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

Wuhan, Hubei, China

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

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Third Xiangya Hospital, Central South University

Changsha, Hunan, China

Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The Second Affiliated Hospital of Soochow Universit

Suzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Jilin Provincial Cancer Hospital

Changchun, Jilin, China

he First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Cancer Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Affiliated Hospital of Jining Medical University

Jining, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

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

Xian, Shanxi, China

The Second Affiliated Hospital of PLA Air Force Medical University

Xian, Shanxi, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

Cancer in Zhejiang Province

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Taizhou First People's Hospital

Taizhou, Zhejiang, China

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

Peking Union Medical College Hospital

Beijing, China

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

Beijing, China

Peking University Cancer Hospital

Beijing, China

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (52)