Non-Small Cell Lung CancerMOTION-NSCLCNCT06709274

Minimal Residual Disease Guiding Adjuvant Therapy in Stage I NSCLC

A study testing Osimertinib, Alectinib and TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy in people with Non-Small Cell Lung Cancer, run by Guangdong Association of Clinical Trials at 15 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

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Non-Small Cell Lung Cancer
What is being tested?: Osimertinib, Alectinib and TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 342 participants
Where: 15 sitesChina
Study dates: Nov 2024to Jan 2032
Phase: Interventional
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Non-small cell lung cancer (NSCLC) confirmed by histological and/or cytological examination. Invasive subtypes are required for adenocarcinomas.
Stage IA or IB after surgery based on pathological TNM8 staging criteria established by the International Union Against Cancer/American Joint Committee on Cancer (8th Edition).
Completely surgical resection (R0) of the primary NSCLC via lobectomy, segmentectomy, or sleeve lobectomy. The gross tumor must be entirely removed, and all surgical margins of the excised tumor must be negative.
Complete recovery from surgery with no evidence of disease progression within 2 weeks prior to the first treatment decision.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
Minimum life expectancy of ≥12 weeks.

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Demonstrate adequate organ function, including:
Hematological parameters:
Absolute neutrophil count ≥1.5×10^9/L
Platelet count ≥100×10^9/L
Hemoglobin ≥90 g/L
Liver function:
ALT ≤2.5× upper limit of normal (ULN)
AST ≤2.5×ULN
Total Bilirubin (TBL) ≤1.5×ULN Renal function: Creatinine level ≤1.25×ULN, or creatinine clearance ≥60 mL/min (measured or calculated using the Cockcroft-Gault formula).
Male or female, age between 18 and 75 years.
Written informed consent must be obtained from the subject or their legal representative.
Participants regardless of sex must agree to use effective contraception during the study period and for 3 months following treatment completion.
Willingness and ability to comply with visit schedules, treatment plans, and laboratory assessments.

Who cannot join

Histopathologically confirmed small cell carcinoma components.
Presence of multiple pulmonary nodules.
Incomplete resections (R1/R2) or resections via bilateral lobectomy, pneumonectomy, or wedge resection.
A history of any systemic anti-tumor treatment, including but not limited to surgery, neoadjuvant chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
Significant allergies to any targeted drugs, immunotherapies, or chemotherapy agents used in the study.
Previous use of any traditional Chinese medicine with anti-tumor properties, or use of such medicine within 2 weeks prior to surgery.

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History of other malignancies within the past 5 years, with the exception of the following:
Other malignancies fully cured by surgery with a disease-free survival of more than 10 years
Curable basal cell carcinoma of the skin
Bladder carcinoma in situ
Cervical carcinoma in situ
History of interstitial lung disease, drug-induced interstitial lung disease, radiation-induced pneumonia requiring steroid treatment, or any evidence of clinically active interstitial lung disease.
Active hepatitis B, defined as HBsAg positive with an HBV-DNA copy number exceeding the ULN established by the study center, accompanied by abnormal liver function, or requiring treatment as evaluated by the investigator.
Presence of any unstable systemic disease, including but not limited to active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the past 3 months, serious arrhythmias that requires medication, liver disease, kidney disease, or metabolic disorders.
Evidence of any other diseases, neurological or metabolic disorders, or physical exam or laboratory findings that may suggest contraindications for the investigational drug, or a high risk for treatment-related complications.
Any of the following cardiac conditions:
Resting ECG QT interval (QTc) > 470 msec.
Significant abnormalities in rhythm, conduction, or morphology on resting ECG, including complete left bundle branch block, third-degree atrioventricular block, or second-degree atrioventricular block
Factors increasing the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death in a first-degree relative under the age of 40, or use of medications known to prolong QT interval.
Blood transfusion within 2 weeks prior to and during the surgery.
History of alcohol or drug abuse.
Pregnant or breastfeeding females.
Any other factors that the investigator deems may affect the progress of the study or compromise the trial data

Trial locations and contacts

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

Xue-Ning Yang, M.D. contact

020-83827812

yangxuening@gdph.org.cn

City, postcode or hospital

15 sites in 1 country

China15 sites

Hunan Cancer Hospital
Changsha, Hunan
Wenxiang Wang, MD, +8613808454225, 2460585948@qq.com
Xiangya Hospital of Central South University
Changsha, Hunan
Yang Gao, MD, +8613973171096, Drgaoyang@sina.cn
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Gang Feng, MD, +8618981838656, steedvan@163.com
The Third People's Hospital of Chengdu
Chengdu, Sichuan
Yi Yang, MD, +8613980013944, cd3yyyy@126.com
Dongguan People's Hospital
Dongguan, Guangdong
Jianping Zhou, MD, +8613332673999, 348089075@qq.com
The First People's Hospital of Foshan
Foshan, Guangdong
Weiquan Gu, MD, +8618038865071, gwquan@fsyyy.com
Guangdong Provincial People's Hostpital
Guangzhou, Guangdong
Xuening Yang, MD, +8620-83827812, yangxuening@gdph.org.cn
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong
Guibin Qiao, MD, +8613602749153, guibinqiao@126.com
Guizhou Provincial People's Hospital
Guiyang, Guizhou
Chuan Xu, MD, +8613985520269, xuchuan627@sina.com
Jiangsu Cancer Hospital
Nanjing, Jiangsu
Rong Yin, MD, +8618305185629, rong_yin@njmu.edu.cn
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
Lei Xian, MD, +8613977182059, xianlei59@163.com
Affiliated Hospital of Nantong University
Nantong, Jiangsu
Jianle Chen, MD, +8615950806806, jsshcjl@163.com
Peking University Shenzhen Hospital
Shenzhen, Guangdong
Xiaoqiang Li, MD, +8613480978588, polygene@139.com
Shenzhen People's Hospital
Shenzhen, Guangdong
Lin Yang, MD, +8613798314779, 13798314779@163.com
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei
Ni Zhang, MD, +8613871288490, zhangnidoc@163.com

Other trials in China

About this study

Official title: Minimal Residual Disease (MRD)-Guided Adjuvant Therapy in Stage I Non-Small Cell Lung Cancer: A Prospective, Multicenter, Randomized Controlled Study

This investigator-initiated study aims to evaluate the effectiveness of minimal residual disease (MRD) as a biomarker for guiding adjuvant therapy decisions in patients with Stage I non-small-cell lung cancer (NSCLC). The study will compare outcomes between an MRD-guided management group and a standard-of-care group, focusing on whether the use of MRD information can improve the 3-year disease-free survival rate compared to existing treatment protocols. Participants in the MRD-guided management group will receive targeted therapy, immunotherapy, or observation based on their postoperative MRD status, while those in the standard-of-care group will receive treatments or observation according to current clinical guidelines.

Conditions: Non-Small Cell Lung Cancer
Being tested: Osimertinib, Alectinib, TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy
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.

OsimertinibDrug
80mg daily, for EGFR-positive patients
AlectinibDrug
600mg BID, for ALK-rearranged patients
TORIPALIMAB INJECTION (JS001 ) combine with chemotherapyDrug
Toripalimab 240mg + Platinum-based chemotherapy (Q3W for 4 cycles), followed by Toripalimab maintenance therapy (240mg Q3W for one year), for EGFR/ALK wildtype patients

Study groups in NCT06709274
Study group	Role	What they receive
MRD-guided management	Experimental	Patients who are MRD-positive after surgery in the MRD-guided management group receive adjuvant therapy. Patients who are MRD-negative in the MRD-guided management group are monitored through observation. Receives: Drug: Osimertinib; Drug: Alectinib; Drug: TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy
Standard of care	No intervention	Adjuvant therapy is not recommended. However, if the physician and patient decide on adjuvant therapy, the treatment regimen and cycle must be documented. Researchers are strongly advised to follow the medication guidelines laid out in the Chinese Society of Clinical Oncology (CSCO) Clinical Practice Guidelines.

What is being measured

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

3-Year disease-free survival (DFS) Rate
The proportion of patients remain disease-free at the 3-year mark starting from the day of randomization
Measured: 3 years post randomization

Secondary outcomes (6)

5-Year disease-free survival (DFS) Rate
The proportion of patients remain disease-free at the 5-year mark starting from the day of randomization
Measured: 5 years post randomization
5-Year overall survival (OS) rate
The proportion of patients remain alive at the 5-year mark starting from the day of randomization
Measured: 5 years post randomization
Disease-free survival (DFS)
Defined as the time from randomization to the first recorded instance of tumor recurrence or metastasis, whichever occurs first
Measured: Up to 8 years post randomization
Overall survival
Defined as the time from the day of randomization to death from any cause
Measured: Up to 8 years post randomization
Quality of Life (QoL) Assessed using the EORTC QLQ-C30 (Version 3.0)
Assessed using the EORTC QLQ-C30 (Version 3.0), developed by the European Organization for Research and Treatment of Cancer.
EORTC QLQ-C30 (Version 3.0) is utilized to assess the overall quality of life in cancer patients. It measures a global health status/QoL scale, five functional scales, three symptom scales, and six single items. Each dimension is scored on a scale from 0 to 100, where a high score for the global health status/QoL represents a high QoL, a high score for a functional scale represents a high/healthy level of functioning, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: Up to 8 years post randomization
Quality of Life (QoL) Assessed using the EORTC QLQ-LC13
Assessed using the EORTC QLQ-LC13, developed by the European Organization for Research and Treatment of Cancer.
EORTC QLQ-LC13 is a supplementary module focusing specifically on the quality of life of patients with lung cancer. It provides additional insights into symptoms and problems related to lung cancer and its treatment. Like the QLQ-C30, responses are measured on a scale from 0 to 100, where higher scores indicate greater severity of symptoms
Measured: Up to 8 years post randomization

Timeline

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

Nov 2024Jan 2032

First posted29 Nov 2024
Study startNov 2024 (estimated)
Primary completionJan 2029 (estimated)
Study completionJan 2032 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 342 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06709274
Sponsor's protocol ID: CTONG2301
Acronym: MOTION-NSCLC
Status last verified: Nov 2024
First submitted: 25 Nov 2024
Last updated: 29 Nov 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Minimal Residual Disease (MRD)-Guided Adjuvant Therapy in Stage I Non-Small Cell Lung Cancer: A Prospective, Multicenter, Randomized Controlled Study
ClinicalTrials.gov ID: NCT06709274
Acronym / sponsor ID: MOTION-NSCLC / CTONG2301
Conditions: Non-Small Cell Lung Cancer
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 342 participants (estimated)
Lead sponsor: Guangdong Association of Clinical TrialsUniversity, hospital or other
Collaborators: Nanjing Geneseeq Technology Inc.
Study start: Nov 2024 (estimated)
Primary completion: Jan 2029 (estimated)
Study completion: Jan 2032 (estimated)
First posted: 29 Nov 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MRD-guided management	Experimental	Drug: Osimertinib, Drug: Alectinib, Drug: TORIPALIMAB INJECTION (JS001 ) combine with chemotherapyPatients who are MRD-positive after surgery in the MRD-guided management group receive adjuvant therapy. Patients who are MRD-negative in the MRD-guided management group are monitored through observation.
Standard of care	No intervention	–Adjuvant therapy is not recommended. However, if the physician and patient decide on adjuvant therapy, the treatment regimen and cycle must be documented. Researchers are strongly advised to follow the medication guidelines laid out in the Chinese Society of Clinical Oncology (CSCO) Clinical Practice Guidelines.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

Non-small cell lung cancer (NSCLC) confirmed by histological and/or cytological examination. Invasive subtypes are required for adenocarcinomas.
Stage IA or IB after surgery based on pathological TNM8 staging criteria established by the International Union Against Cancer/American Joint Committee on Cancer (8th Edition).
Completely surgical resection (R0) of the primary NSCLC via lobectomy, segmentectomy, or sleeve lobectomy. The gross tumor must be entirely removed, and all surgical margins of the excised tumor must be negative.
Complete recovery from surgery with no evidence of disease progression within 2 weeks prior to the first treatment decision.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.

Key exclusion criteria (23 listed)

Histopathologically confirmed small cell carcinoma components.
Presence of multiple pulmonary nodules.
Incomplete resections (R1/R2) or resections via bilateral lobectomy, pneumonectomy, or wedge resection.
A history of any systemic anti-tumor treatment, including but not limited to surgery, neoadjuvant chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
Significant allergies to any targeted drugs, immunotherapies, or chemotherapy agents used in the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Osimertinib80mg daily, for EGFR-positive patients	Drug	MRD-guided management
Alectinib600mg BID, for ALK-rearranged patients	Drug	MRD-guided management
TORIPALIMAB INJECTION (JS001 ) combine with chemotherapyToripalimab 240mg + Platinum-based chemotherapy (Q3W for 4 cycles), followed by Toripalimab maintenance therapy (240mg Q3W for one year), for EGFR/ALK wildtype patients	Drug	MRD-guided management

Primary outcome

3-Year disease-free survival (DFS) Rate
Time frame: 3 years post randomization
The proportion of patients remain disease-free at the 3-year mark starting from the day of randomization

6 secondary outcomes

5-Year disease-free survival (DFS) Rate
Time frame: 5 years post randomization
5-Year overall survival (OS) rate
Time frame: 5 years post randomization
Disease-free survival (DFS)
Time frame: Up to 8 years post randomization
Overall survival
Time frame: Up to 8 years post randomization
Quality of Life (QoL) Assessed using the EORTC QLQ-C30 (Version 3.0)
Time frame: Up to 8 years post randomization
Quality of Life (QoL) Assessed using the EORTC QLQ-LC13
Time frame: Up to 8 years post randomization

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Xue-Ning Yang, M.D. contact

020-83827812

yangxuening@gdph.org.cn

Yi-Long Wu, M.D. principal investigator

Guangdong Provincial People's Hospital

Xue-Ning Yang, M.D. principal investigator

Guangdong Provincial People's Hospital

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 19 inclusion and 23 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 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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.

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 Xue-Ning Yang, M.D. (020-83827812, yangxuening@gdph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-Year disease-free survival (DFS) Rate (time frame: 3 years post randomization). 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 NCT06709274.

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 29 Nov 2024.