Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Subjects will be randomly assigned to groups A and B after radical therapy (surgery or radiothrapy) and will receive 110 mg of almonertinib once a day for 2 years or until disease recurrence or metastasis.

Subjects will be randomly assigned to group B after radical therapy (surgery or radiothrapy) and will receive almonertinib guided by ctDNA dynamic monitoring (every 3 months test ctDNA once, if it is positive, continue to receive almonertinib 110 mg once a day, if it is negative, stop almonertinib until ctDNA turns positive and receive almonertinib treatment again).

ctDNA dynamic monitoring guided the Almonertinib treatment group after redical surgery orradiotherapy

Almonertinib

Yi-Long Wu, doctor

Qing Zhou, MD

Kai can Cai

Guang Hai

Hui Wang

Hui Luo

Qi xun Chen

Dong Qian

Zi li Meng

Di Ge

Yu sheng Su

Bao gang Liu

Yun peng Liu

Jun Zhao

Qing song Pang

Bao sheng Li

Yun chao Huang

Qi feng Wang

Ge Wang

Jun Yao

Yan qiu Zhao

Wei hua Yang

Shuan ying Yang

This is an open-label, multi-center, randomized, phase III study. It is aimed to firstly evaluate the effectiveness and safety of almonertinib induction therapy in EGFR-mutated patients with unresectable stage III non-small cell lung cancer, and to evaluate the effectiveness and safety of dynamic MRD guided maintenance therapy with almonertinib after induction therapy with almonertinib and local therapy (radical surgery or radiotherapy) evaluated by MDT diagnostic model. The study includes a screening period (not more than 28 days after the subject with signed informed consent before first medication), treatment period (including induction therapy with almonertinib\\ radical therapy under MDT model\\ consolidation therapy with almonertinib) and follow-up period.

This is an open-label, multi-center, randomized, phase III study. It is aimed to firstly evaluate the effectiveness and safety of almonertinib induction therapy in EGFR-mutated patients with unresectable stage III non-small cell lung cancer, and to evaluate the effectiveness and safety of dynamic MRD guided maintenance therapy with almonertinib after induction therapy with almonertinib and local therapy (radical surgery or radiotherapy) evaluated by MDT diagnostic model. The study includes a screening period (not more than 28 days after the subject with signed informed consent before first medication), treatment period (including induction therapy with almonertinib\\ radical therapy under MDT model\\ consolidation therapy with almonertinib) and follow-up period.

Eligible subjects receive 110 mg of almonertinib once a day for 8 consecutive weeks of induction therapy; local treatment (surgical or radical radiotherapy) is selected after MDT assessment. Subjects will be randomly assigned to groups A and B. Stratification factors included EGFR 19deletion or EGFR 21L858R mutation; shedding or non-shedding ctDNA at baseline; radical surgery or radiotherapy under MDT model.

Subjects in group A will receive 110 mg of almonertinib once a day for 2 years. Imaging evaluation is conducted every 12 weeks. Subjects in group B will receive almonertinib guided by dynamic MRD monitoring. When ctDNA was positive (MRD+), subjects will receive 110 mg of almonertinib once a day for 12 weeks; when ctDNA was negative (MRD-), subjects will stop almonertinib and be observed for 12 weeks. This model will continue until disease recurrence or metastasis.

MRD Guiding Treatment After Almonertinib Induction Therapy for EGFRm+ Stage III NSCLC in the MDT Diagnostic Model.

Effectiveness and Safety of Dynamic MRD Guiding Treatment After Aumolertinib Induction Therapy of EGFR-mutation-positive Unresectable Stage III Non-Small Cell Lung Cancer in the MDT Diagnostic Model: an Open-label, Multicenter, Randomized, Phase III Study

The objective response rate (ORR) was assessed by IRC for all eligible subjects after 8 weeks of Almonertinib induction therapy.

Until the disease progresses or in the absence of disease progression, the last evaluable data will be recorded in the ORR assessment. However, any CR or PR that occurs after the termination of the study treatment and receiving further anti-tumor therapy will not be included in the ORR calculation.

The 18 months event-free survival period is defined as the time from random to the occurrence of any of the following events within 18 months, whichever occurs first:

Tumor progression assessed by IRC according to RECIST 1.1; Tumor recurrence confirmed by IRC, including local recurrence or distant metastasis; Death caused by any cause.

The objective response rate (ORR) was assessed by investigators for all eligible subjects after 8 weeks of Almonertinib induction therapy.

Until the disease progresses or in the absence of disease progression, the last evaluable data will be recorded in the ORR assessment. However, any CR or PR that occurs after the termination of the study treatment and receiving further anti-tumor therapy will not be included in the ORR calculation.

The 18 months event-free survival period is defined as the time from random to the occurrence of any of the following events within 18 months, whichever occurs first:

Tumor progression assessed by investigators according to RECIST 1.1; Tumor recurrence confirmed by investigators, including local recurrence or distant metastasis; Death caused by any cause.

The event-free survival period is defined as the time from random to the occurrence of any of the following events, whichever occurs first:

Tumor progression assessed by IRC according to RECIST 1.1; Tumor recurrence confirmed by IRC, including local recurrence or distant metastasis; Death caused by any cause.

Overall survival is defined as the time between the date of first administration and the date of death of the subject for any reason.Subjects not dead at the time of the statistical analysis will be truncated at the time when the subject was last known to be alive.

The major pathological response rate is defined as the incidence of tumor regression induced by neoadjuvant therapy with pathological residual tumor ≤10% (only applicable to subjects who have received surgical treatment).

To evaluate number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Quality of Life assessed by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire core 30(EORTC QLQ-C30)

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Guangdong Association of Clinical Trials

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

The standard care group is the routine care group, that is, under the current standard antitumor treatment and follow-up mode, the patients independently decided whether to carry out nutritional and psychological intervention after the advice from the medical care department of oncology

The MDT care group is the whole-course multidisciplinary care intervention group, which is conducted by a multidisciplinary team composed of the oncology department, nutrition department, mental health center and rehabilitation department.

On the basis of standard treatment, all patients were evaluated by senior practice nurses in the Department of Oncology in person at the time of enrollment (before radiotherapy) and once every week during radiotherapy, and once in person/over the phone at 1, 2, 3, and 6 months after radiotherapy.

Whole-Course Multidisciplinary Care Intervention

Xingchen Peng, Ph.D

Radiotherapy is one of the main treatments for head and neck Carcinoma. The incidence of radiotherapy-related adverse events is greater than 90%, and severe adverse events may lead to the interruption of radiotherapy.

Interruption of radiotherapy on the one hand affects the efficacy of tumor treatment, on the other hand seriously affects the quality of life of patients.

Investigators intend to conduct a randomized, controlled clinical study of multidisciplinary nutritional and psychological care for patients receiving radiotherapy for head and neck carcinoma, with a view to reducing the rate of radiotherapy interruption and improving the quality of life of patients with radiotherapy for head and neck carcinoma through a whole-course multidisciplinary care model.

Effect of Whole-Course Multidisciplinary Care Intervention on Patients With Head and Neck Carcinoma

Effect of an Oncology Nurse-Led Whole-Course Multidisciplinary Care Intervention on Patients With Head and Neck Carcinoma Receiving Radiotherapy

Interruption of radiotherapy was defined as the actual end date of radiotherapy minus the expected end date at least 5 days

Quality of life score was calculated according to the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ C30)

Quality of life score was calculated according to the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire QLQ-HN35

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MRD Guiding Treatment After Almonertinib Induction Therapy for EGFRm+ Stage III NSCLC in the MDT Diagnostic Model.	NCT04841811	Lung Cancer	Almonertinib	18 Years - 70 Years	Guangdong Association of Clinical Trials
MRD Guiding Treatment After Almonertinib Induction Therapy for EGFRm+ Stage III NSCLC in the MDT Diagnostic Model.	NCT04841811	Lung Cancer	Almonertinib	18 Years - 70 Years	Guangdong Association of Clinical Trials
Effect of Whole-Course Multidisciplinary Care Intervention on Patients With Head and Neck Carcinoma	NCT05828004	Head and Neck C...	Whole-Course Mu...	18 Years -	West China Hospital

Spots Global Cancer Trial Database for mdt

Every month we try and update this database with for mdt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mdt

Every month we try and update this database with for mdt cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mdt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.