AzTrials
AzTrials

Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)Phase 3NCT05767892

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

A Phase 3 study testing YK-209A tablet and Pemetrexed+carboplatin/Cisplatin in people with Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC), run by Suzhou Puhe Pharmaceutical Technology Co., LTD at 52 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
YK-209A tablet and Pemetrexed+carboplatin/Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
52 sitesChina
Study dates
1 May 2023to 31 Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.

Who cannot join

  • 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。
Show all 10Show fewer
  • 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).

Trial locations and contacts

52 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Hui Zhao, Doctor contact

+8618911018556

zh@puhebiopharma.com

52 sites in 1 country

China52 sites

  • Beijing Chest Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100102

    Zhe Liu

  • Peking Union Medical College Hospital

    Beijing, 10000

    Li Zhang

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

    Beijing, 100102

    Jie Wang, Doctor

    Jie Wang, Doctor

  • Peking University Cancer Hospital

    Beijing, 100102

    Jun Zhao, Doctor

  • The First Affiliated Hospital of Bengbu Medical Colleg

    Bengbu, Anhui, 233000

    Chenling Zhao

  • Jilin Provincial Cancer Hospital

    Changchun, Jilin, 130000

    Yin Chen

  • Hunan Cancer Hospital

    Changsha, Hunan, 410000

    Lin Wu

  • Third Xiangya Hospital, Central South University

    Changsha, Hunan, 410000

    Xuewen Liu

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610000

    Ke Xie

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610000

    Dan Liu

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400000

    Tao Zhang

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400000

    Zhengzhou Yang

  • Fujian Provincial Cancer Hospital

    Fuzhou, Fujian, 350000

    Yunjian Huang

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

    Guangzhou, Guangdong, 510000

    Minhui Wang

  • Cancer Hospital Affiliated to Guangzhou Medical University

    Guangzhou, Guangdong, 510080

    Chuan Jing

  • The First Affiliated Hospital of Guangdong Pharmaceutical University

    Guangzhou, Guangdong, 510080

    Xicheng Wang

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou, 550000

    Xianwei Ye

  • Cancer in Zhejiang Province

    Hangzhou, Zhejiang, 310000

    Yun Fan

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

    Hangzhou, Zhejiang, 310000

    Y Fang

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

    Jianya Zhou

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

    Baogang Liu

  • Anhui Provincial Chest Hospital

    Hefei, Anhui, 230000

    Xuhong Min

  • Anhui Provincial Hospital

    Hefei, Anhui, 230000

    Yueyin Pan

  • Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 010000

    Junzhen Gao

  • Cancer Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong, 250000

    Haiyong Wang

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250000

    Lian Liu

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong, 272000

    Shuchen Ye

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650000

    Runxiang Yang

  • Gansu Provincial Cancer Hospital

    Lanzhou, Gansu, 730030

    Lei Yang

  • he First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471000

    Yeye Zhang

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

    Longhua Sun

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

    Xiaoqun Ye

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, l330000

    Hui Luo

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210000

    Renhua Guo

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000

    Helei Lou

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200000

    Peng Zhang

  • he First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110000

    Mingfang Zhao

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

    Yudong Wang

  • The Second Affiliated Hospital of Soochow Universit

    Suzhou, Jiangsu, 215000

    Zhixiang Zhuang

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, 030000

    Jianchun Duan

  • Taizhou First People's Hospital

    Taizhou, Zhejiang, 318000

    Lili Chen

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, 318000

    Youzu Xu

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300000

    Dingzhi Huang

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

    Wuhan, Hubei, 430000

    Qian Chu

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

    Wuhan, Hubei, 430000

    Xiaorong Tong

  • Yijishan Hospital of Wannan Medical College

    Wuhu, Anhui, 241000

    Zhiwei Lu

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361000

    Jinxun Wu

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

    Xian, Shanxi, 710000

    Yu Y

  • The Second Affiliated Hospital of PLA Air Force Medical University

    Xian, Shanxi, 710000

    Haichuan Su

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

    Yanqiu Zhao

  • The First Affiliated Hospital of Zhengzhou University

    Zhenzhou, Henan, 450000

    Xingya Li

  • People's Hospital of Zhongshan City

    Zhongshan, Guangdong, 528400

    Jiewen Peng

Other trials in China

About this study

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

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.

Read the 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.

Being tested
YK-209A tablet, Pemetrexed+carboplatin/Cisplatin
Keywords
NSCLC, EGFR, EXON 20ins
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YK-209A tabletDrug

    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.

  • Pemetrexed+carboplatin/CisplatinDrug

    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.

Study groups in NCT05767892
Study groupRoleWhat they receive
YK-029A Group (Arm A)ExperimentalNot described
Receives: Drug: YK-209A tablet
Platinum-based Chemotherapy Group (Arm B)Active comparatorNot described
Receives: Drug: Pemetrexed+carboplatin/Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to approximately 36 months after the first participant is randomized.

Secondary outcomes (8)

  1. Confirmed Objective Response Rate (ORR) as Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1

    Confirmed ORR is defined as the percentage of participants who are confirmed to have achieved complete response (CR) or partial response (PR). Confirmed responses are responses that persist on repeat imaging ≥4 weeks after initial response.

    Measured: Up to approximately 36 months after the first participant is randomized.

  2. Overall Survival (OS)

    OS is defined as the interval from the date of randomization until death.

    Measured: Up to approximately 36 months after the first participant is randomized.

  3. Progression Free Survival (PFS) as Assessed by the Investigator

    PFS is defined as the time interval from the date of randomization until the first date at which the criteria for PD according to RECIST Version 1.1 are met or death, whichever occurs first.

    Measured: Up to approximately 36 months after the first participant is randomized.

  4. Confirmed Objective Response Rate (ORR) as Assessed by the Investigator

    Confirmed ORR is defined as the percentage of participants who are confirmed to have achieved CR or PR. Confirmed responses are responses that persist on repeat imaging ≥4 weeks after initial response.

    Measured: Up to approximately 36 months after the first participant is randomized.

  5. Duration of Response, as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator.

    Duration of response is defined as the time interval from the time that the measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that PD or death (whichever occurs first) is objectively documented.

    Measured: Up to approximately 36 months after the first participant is randomized.

  6. Disease Control Rate (DCR) as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator

    DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) (in the case of SD, measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks) after the initiation of study drug.

    Measured: Up to approximately 36 months after the first participant is randomized.

  7. Patient-reported Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30

    EORTC QLQ-C30 is a cancer-specific questionnaire which comprises of 5 functional scales (physical, role, cognitive, emotional, and social functioning); 3 symptom scales (fatigue, pain, and nausea/vomiting); and a global health status/quality-of-life (QoL) scale. Six single-item scales are also included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Raw scores will be converted into scale scores ranging from 0 to 100. For the functional scales and the global health status/QoL scale, higher scores represent better HRQoL, whereas for the symptom scales lower scores represent better HRQoL (i.e., a low level of symptomatology/problems).

    Measured: Up to approximately 36 months after the first participant is randomized.

  8. Participant-reported Symptoms as Assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire, Lung Cancer Module (QLQ-LC13).

    EORTC QLQ-LC13 is a cancer-specific questionnaire which comprises of 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and use of pain medication. Raw scores will be converted into scale scores ranging from 0 to 100. Higher scores represent a high level of symptomatology/problems.

    Measured: Up to approximately 36 months after the first participant is randomized.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2023
  2. Study start1 May 2023 (estimated)
  3. Primary completion30 Jul 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
None (open label)
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05767892
Sponsor's protocol ID
SZPH-2023-001
Status last verified
Mar 2023
First submitted
1 Mar 2023
Last updated
5 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing YK-209A tablet and Pemetrexed+carboplatin/Cisplatin in people with Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC), run by Suzhou Puhe Pharmaceutical Technology Co., LTD at 52 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hui Zhao, Doctor (+8618911018556, zh@puhebiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) as Assessed by Blinded Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 . (time frame: Up to approximately 36 months after the first participant is randomized.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05767892.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT05767892 | AzTrials