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Immune Checkpoint Inhibitors

Microwave ablation plus Camrelizumab (no more than 16 cycles)

Tumor received treatment of microwave ablation and received no more than 16 cycles of Camrelizumab

Microwave ablation plus Camrelizumab

Tumor received treatment of microwave ablation

Microwave ablation

Chang Chen, Dr

Chong Bai, Dr

Zheng Ruan

Chang Chen, MD, PhD

Wei Chen

Chuanwu Cao

Jiachang Chi

Prospective, multi-center, phase II clinical trial. The study plans to enroll 146 patients with multiple lung cancers. After signing the informed consent, they were screened to meet the admission and discharge criteria, and received microwave ablation treatment. Electromagnetic navigation bronchoscope-guided intrapulmonary microwave ablation or percutaneous microwave ablation was selected according to the patient's wishes and the evaluation of the surgeon. After the operation, they were randomized and the experimental group accepted PD-1 immune checkpoint inhibitor treatment (microwave ablation combined with Camrelizumab treatment does not exceed 16 cycles, or disease progression/worsening or confirmed imaging disease progression, or withdrawal for any reason), the control group does not After receiving any treatment, the two groups were followed up closely (36 months after the last treatment, including safety follow-up and survival follow-up).

Efficiency and Safety of Microwave Ablation Plus Immune Checkpoint Inhibitor for Patients With Multiple Primary Lung Cancer: A Open, Multi-center, Phase II Clinical Trial

Shanghai Pulmonary Hospital, Shanghai, China

Shanghai Pulmonary Hospital

Stereotactic ablation radiotherapy (SABR) was performed sequentially on the primary and secondary lesions. Sintilimab was used 2 weeks after the end of SABR. Sintilimab : 200 mg intravenously, Q3W every cycle , given on the D1 of each cycle, and total of 4 cycles.

Stereotactic ablation radiotherapy was performed sequentially on the primary and secondary lesions. 50Gy/4F or 70Gy/10F were used according to the specific location of the tumor。

Stereotactic Ablation Radiotherapy

Sintilimab was started 2 weeks after the end of radiotherapy. Sintilimab : 200 mg intravenously, Q3W every cycle , given on the D1 of each cycle, and total of 4 cycles

Sintilimab

Deng Chong, MD

Jiang Jie, MD

Jiang jie, MD

The purpose of this study is to assess of the Safety and Effects of Stereotactic Ablation Radiotherapy (SABR) combined with Sintilimab in early inoperable synchronous Multiple Primary Lung Cancer (sMPLC)

Stereotactic ablation radiotherapy (SABR) was performed sequentially on the primary and secondary lesions. 50Gy/4F or 70Gy/10F were used according to the specific location of the tumor. Immunotherapy was started 2 weeks after the end of radiotherapy. Sintilimab : 200 mg intravenously, Q3W every cycle , given on the D1 of each cycle, and total of 4 cycles.

Stereotactic Ablation Radiotherapy Combined With Sintilimab in Early Inoperable Synchronous Multiple Primary Lung Cancer

A Prospective Single-arm Single-center Clinical Study：Assessment of the Safety and Effects of Stereotactic Ablation Radiotherapy (SABR) Combined With Sintilimab in Early Inoperable Synchronous Multiple Primary Lung Cancer (sMPLC)

A reaction produced following irradiation but occurring outside the zone of actual radiation absorption

AE，according to NCI-CTCAE V4.03 and immune-related (ir) RECIST

PFS, defined as the time from treatment to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.

Disease Control Rate（DCR） according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST

The First Affiliated Hospital of Xiamen University

After randomization, the enrolled patients in this arm should be performed path simulation under ENB with preoperative CT. On the operation day, single-cavity intubation will be carried out first, and the secondary lesion will be reached through the planned path. After that，the biopsy tissue of the lesion will be sent to ROSE for detection. If malignant，the ablation will be performed，and the location, energy and ablation time will be adjusted according to intraoperative CT. After ablation, radical surgery will be performed on the primary lesion.

The control group will undergo VATS treatment on the primary lesion on the day of operation, and will be re-admitted to the hospital after discharge and recovery (3-4 months) for contralateral secondary lesion surgery.

ENB guide MWA combine ENB, microwave ablation and 3D reconstruction technology, and guide the probe in the airway to the target lesion for ablation therapy, which is safe and effective. For patients with synchronous bilateral multiple primary pulmonary nodules, ENB guide MWA combined with VATS treatment can not only avoid the risk of bilateral surgery, but also complete the "one-stop" treatment, which is a new treatment mode.

ENB guided MWA combined with VATS

Bilateral surgery is a traditional treatment, but it will lead to increased intraoperative risk and postoperative complication rate, and more likely to lead to postoperative complications such as decreased quality of life and cardiopulmonary dysfunction.

sequential surgery

Hecheng Li, PhD, MD

Dingpei Han, PhD, MD

Hecheng LI, PhD, MD

The goal of this clinical trial is to evaluate the safety and efficacy of ENB guided MWA combined with VATS versus sequential surgery for synchronous bilateral multiple primary lung nodules. Participants will be divided into two group.One group will accepte treatment of ENB guided MWA combined with VATS,another will accepted sequential surgery.

Lung cancer is one of the most common cancers and the leading cause of cancer-related death worldwide. With the improvement of people's health awareness and the wide application of LDCT and HRCT, the incidence of multiple primary lung cancer is increasing, especially the synchronous bilateral multiple primary pulmonary nodules are the difficulties in the treatment of pulmonary nodules. Bilateral sequential surgery is associated with higher intraoperative risks, higher rates of postoperative complications, and lower postoperative quality of life. At present, a small number of recent retrospective studies have shown that microwave ablation(MWA) guided by electromagnetic navigation bronchoscopy(ENB) combined with video-assisted thoracic surgery(VATS) treatment can effectively treat bilateral multiple primary pulmonary nodules, which not only has a low complication rate, but also can avoid secondary surgery.

Based on previous studies, the research plans to conduct a prospective, multi-center, randomized controlled study to evaluate the safety and efficacy of ENB guided MWA combined with VATS versus sequential surgery for synchronous bilateral multiple primary lung nodules, as well as its potential value as a new treatment option for these participants.

ENB Guided MWA Combined With VATS Versus Sequential Surgery for Synchronous Bilateral Multiple Primary Lung Nodules

A Prospective, Multi-center, Randomized Controlled Clinical Study of ENB Guided MWA Combined With VATS Versus Sequential Surgery for Synchronous Bilateral Multiple Primary Lung Nodules

The percentage of people with successful biopsy.

The proportion of patients with malignant biopsies in the overall population

Complications refer to operation-related adverse events during and after the operation according to the Clavien-Dindo Classification, including pulmonary infection, Broncho-pulmonary hemorrhage, respiratory failure, pleural effusion, pneumothorax, persistent lung leak, arrhythmia, wound infection, death.

Objective response rate（ORR）is the proportion of patients with complete responses and partial responses.

Number of participants with treatment-related adverse events as assessed by CTCAE 5.0.

the duration of the operation in minutes.

number of death within 30 days after surgery.

complications above grade 3 that need to be treated during and after the operation according to the Clavien-Dindo Classification.

patients' quality of life by questionnaires according to EORTC QLQ-LC29.

forced expiratory volume in one second(FEV1).

DFS : the time from surgical resection to clinically confirmed local recurrence, distant metastasis, second primary tumor diagnosis, or patient death (control group since the second operation).

the patients in control group complete two operations

The overall cost of treatment include direct and indirect costs. Additional costs for hospitalization and surgery.

Sun Yat-sen University

Tang-Du Hospital

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Ruijin Hospital

Professor

Carcinoma, Non-Small-Cell Lung

Kezhong Chen, M.D.

Jun Wang, M.D.

To investigate the evolutionary genomic landscape, explore the genetic tumor heterogeneity and microenvironment of multiple primary lung cancer (MPLC) by using tissue genetic analysis and circulating tumor DNA detection, in order to provide robust evidence for the diagnosis, treatment, and surveillance of MPLC.

Multiple primary lung cancer (MPLC) has become a worldwide problem due to the difficulty in diagnosis, treatment and surveillance. Although exploring tumour clonal heterogeneity and microenvironment can help understand cancer evolution and impact therapeutic outcome, study is still lacking in this field on MPLC. Circulating tumor DNA (ctDNA) are short DNA fragments, which can be obtained conveniently and non-invasively, providing comprehensive views of the tumor as were shed by tumor cells from multiple tumor regions. Therefore, we design a prospective study of patients with surgically treated MPLC, aiming to use ctDNA technique to define the evolutionary landscape of MPLC through inter-tumor and intra-tumor heterogeneity by multi-region sampling and genetic analysis. We will also explore the the microenvironment by RNA sequencing and T cell receptor sequencing. This study may help understand the genetic evolution and microenvironment of MPLC, and provide evidence for the diagnosis, treatment and surveillance of these patients.

Fresh tumor tissue and blood samples were collected from each patient. Time for blood sample collection: 1) Preoperation. 2) The 1st to 3rd day of postoperation.

Evolution of Multiple Primary Lung Cancer (Evolution)

The Genetic Evolution and Microenvironment of Multiple Primary Lung Cancer

Explore the intra-tumor and inter-tumor genetic heterogeneity by analysis of clonal and subclonal mutations detected by ctDNA.

Using RNA sequencing and T cell receptor (TCR) sequencing to evaluate the microenvironment of each lesion of multiple primary lung cancer, including T cell receptpr clonality ,diversity , evenness, and richness.

Explore the correlation between the detection rate of ctDNA and subclonal mutations of different tumor sites detected by genetic analysis.

Explore the correlation between the detection rate of ctDNA and tumor burden.

Guangzhou Burning Rock Medical Examination Institute Co., Ltd.

Peking University People's Hospital

Carcinoma

Targeted next generation sequencing (NGS) provides a promising method for diagnostic purposes by enabling the simultaneous detection of multiple gene mutations. This study is to evaluate the feasibility and application value by using NGS into identifying genomic mutations in multiple or multifocal primary lung cancers in cell-tumor DNA (ctDNA) from surgical patients

Tumor samples originating from clinically considered multiple or multifocal primary lung cancer patients were available for mutational analysis. DNA and RNA were extracted from fresh tumor tissue or formalin-fixed, paraffin-embedded (FFPE) tissue. A series of cancer-related genomic alterations including single nucleotide variations (SNVs), short insertions and deletions (InDels), copy number variations (CNVs) and gene rearrangements were identified by a comprehensive NGS Panal . High frequency mutations were also identified in blood sample by droplet digital polymerase chain reaction(ddPCR).

Fresh tumor tissue, peripheral blood cells, and plasma samples were collected from each patient.

Identifying Genomic Mutations of Multiple Primary Lung Cancers by Circulating Tumor DNA

A Prospective Study of Identifying Genomic Mutations of Multiple Primary Lung Cancers by Circulating Tumor DNA

San Valley Biotechnology Incorporated

MD，Thoracic Surgery Service

Central Nervous System Depressants

Other Dietary Supplements

Imidacloprid

Benzocaine

Aflutinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Tannic Acid

After randomization, the enrolled patients in this arm should be completely free from the risk of perioperative complications or recovered from the effects of complications, usually no earlier than 4 weeks after surgery but no more than 10 weeks after surgery, before receiving baseline follow-up and starting oral administration of Furmonertinib on the day of baseline follow-up. Patients in the treatment group should take Furmonertinib (80 mg each time) orally on an empty stomach before breakfast once a day. The medicine should be taken about the same time each day, by swallowing the whole tablet with water, without crushing or chewing. Patients should maintain oral administration of Furmonertinib for 6 consecutive months, unless there is disease progression, death, new anti-tumor therapy received or intolerance of investigational drugs.

After randomization, the enrolled patients in this arm should be completely free from the risk of perioperative complications or recovered from the effects of complications, usually no earlier than 4 weeks after surgery but no more than 10 weeks after surgery, before receiving baseline follow-up and starting oral administration of placebo on the day of baseline follow-up. Patients in the treatment group should take placebo (80 mg each time) orally on an empty stomach before breakfast once a day. The medicine should be taken about the same time each day, by swallowing the whole tablet with water, without crushing or chewing. Patients should maintain oral administration of placebo for 6 consecutive months, unless there is disease progression, death, new anti-tumor therapy received or intolerance of investigational drugs.

AST2818 is an irreversible and highly selective EGFR inhibitor independently discovered and developed by Allist. It has the potential to become the best-in-class drug in the third-generation EGFR-TKIs. Data from the preclinical studies and the completed clinical studies show that AST2818 has the following advantages: 1) AST2818 has good target selectivity and tissue distribution specificity; 2) The objective response rate of AST2818 for the patients with locally advanced or metastatic NSCLC with EGFR T790M mutation is outstanding, reaching 74.1% in the key registration clinical study; 3) AST2818 has a good safety profile and is well-tolerated; 4) AST2818 and its active metabolites have a superior ability to penetrate the blood-brain barrier, and have a good therapeutic efficacy on brain metastases frequently seen in patients with NSCLC.

furmonertinib

The placebo has the same appearance, weight, and physical and chemical properties as the study drug, and is provided by the researcher to the subjects in control group.

Placebo

Yajia Zhang, PhD, MD

Chun Chen, Phd, MD

Bentong Yu, PhD, MD

Xiaolong Yan

Yajie Zhang, PhD, MD

Jiahao Zhang, MD

Ming Wu, Phd, MD

Jian Hu, PhD, MD

This study is a multi-center, prospective, double-blind randomized controlled clinical trial. The purpose is to evaluate the efficacy and safety of EGFR-TKI on residual GGOs after surgery in patients with multiple primary lung cancers with ground glass nodules. This study is expected to prove that compared with placebo in the control group, EGFR-TKI can significantly reduce the residual GGOs lesions in patients with EGFR-positive multiple primary lung cancers with ground-glass opacity, and bring a higher objective response rate (ORR), thus provides new insights for treatment of these patients.

Lung cancer is one of the most deadly malignant tumors in the world. It is estimated that 0.2-20% of lung cancer patients have multiple primary lung cancers at the time of diagnosis, and many of them present with multiple ground glass opacities. The surgical method for such multiple lesions depends on their number, anatomical location and size, as well as the age and pulmonary function of the patient. It is easily affected by the subjective judgment of the surgeon. Besides, many of these patients develop multiple lesions that cannot be resected at the same time, and there haven't been established a standard therapy for residual GGO lesions after surgery.

According to the National Comprehensive Cancer Network (NCCN) guidelines, EGFR-TKI is recommended for the adjuvant treatment of stage IB-ⅢA NSCLC with EGFR mutations. However, it is not clear whether EGFR-TKI is effective for multiple primary lung cancers or the residual GGOs after surgical resection of the EGFR mutation positive main cancers. At present, there have been retrospective studies showing that application of EGFR-TKIs targeted therapy can significantly reduce the diameter of residual GGOs after surgery resection of EGFR mutation-positive primary lesions for MPLC patients, and reduce the secondary surgery caused by the progression of the lesion. However, there is no prospective Studies confirming the efficacy and safety of EGFR-TKI on these postoperative residual GGOs lesions.

This study is a multi-center, prospective, double-blind, comparative clinical research. This study plans to enroll 138 patients with multiple primary lung cancers (cTis-T1c, N0, M0) that manifest GGO and cannot be resected at the same time, patients should have undergone surgical resection of the EGFR mutated main lesion, and have no less than 1 GGO lesion remaining after surgery. Eligible patients will be randomly divided into the treatment group (receiving furmonertinib mesilate tablets) or control group (placebo) at a ratio of 1:1. The grouping process was strictly double-blind for both the investigators and subjects. By collecting the relevant data of patients' baseline images, pathology, and follow-up images during treatment, statistical analysis is used to evaluate the effectiveness (response rate, objective remission rate), safety, and relevant influencing factors (including CTR value of the main lesion, number of residual lesions, diameter of the largest residual lesion, higher stage of the main lesion, residual lesion's density, etc.) of EGFR-TKI treatment.

This study is expected to prove that compared with the placebo in the control group, EGFR-TKI can significantly reduce the diameter of residual GGO lesions in patients with EGFR-positive multiple primary lung cancers with ground-glass density, and bring a higher objective response rate (ORR) but did not significantly increase the incidence of adverse effects.

This study has two parallel arms, EGFR-TKI treatment arm and control arm (placebo) are included in this study.

This study is a double-blind trial, the investigator, care provider and patients are all blinded.

Treatment of EGFR-TKI for Residual Lesions of Multiple Synchronous Ground-glass Opacities

A Prospective, Multi-center, Double-blind Randomized Controlled Clinical Trial on the Treatment of EGFR-TKI for Residual Lesions of Multiple Synchronous Ground-glass Opacities

defined in this study as the ratio of patients with reduced diameter of any residual lesions on CT scans to the entire patient cohort according to the Independent Review Committee (IRC) image evaluation follow-up.

Defined as the ratio of lesions showing any reduction in diameter on the CT scan to the number of lesions in the entire cohort according to the Independent Review Committee (IRC) image evaluation during follow-up.

ORR is evaluated after 6 months of treatment, defined according to the RECIST1.1 standard

compared with the primary endpoint of Independent Review Committee (IRC) image evaluation

Number of subjects who had a second resection of residual lesions due to progress of lesions during follow-up.

the number and grades of treatment-related adverse events in each arm (grading according to CTCAE 5.0)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficiency and Safety of Microwave Ablation Plus Immune Checkpoint Inhibitor for Patients With Multiple Primary Lung Cancer: A Open, Multi-center, Phase II Clinical Trial	NCT05053802	Multiple Primar...	Microwave ablat... Microwave ablat...	18 Years - 79 Years	Shanghai Pulmonary Hospital, Shanghai, China
Stereotactic Ablation Radiotherapy Combined With Sintilimab in Early Inoperable Synchronous Multiple Primary Lung Cancer	NCT04840758	Multiple Primar...	Stereotactic Ab... Sintilimab	18 Years - 75 Years	The First Affiliated Hospital of Xiamen University
ENB Guided MWA Combined With VATS Versus Sequential Surgery for Synchronous Bilateral Multiple Primary Lung Nodules	NCT05662553	Multiple Primar...	ENB guided MWA ... sequential surg...	18 Years - 80 Years	Ruijin Hospital
Evolution of Multiple Primary Lung Cancer (Evolution)	NCT04326751	Multiple Primar... Lung Cancer Non Small Cell ...		18 Years - 80 Years	Peking University People's Hospital
Identifying Genomic Mutations of Multiple Primary Lung Cancers by Circulating Tumor DNA	NCT02833467	Carcinoma Non-small-cell ... Thoracic Neopla...		18 Years -	Peking University People's Hospital
Stereotactic Ablation Radiotherapy Combined With Sintilimab in Early Inoperable Synchronous Multiple Primary Lung Cancer	NCT04840758	Multiple Primar...	Stereotactic Ab... Sintilimab	18 Years - 75 Years	The First Affiliated Hospital of Xiamen University
Treatment of EGFR-TKI for Residual Lesions of Multiple Synchronous Ground-glass Opacities	NCT04982900	Multiple Primar...	furmonertinib Placebo	18 Years - 80 Years	Ruijin Hospital
Identifying Genomic Mutations of Multiple Primary Lung Cancers by Circulating Tumor DNA	NCT02833467	Carcinoma Non-small-cell ... Thoracic Neopla...		18 Years -	Peking University People's Hospital

Spots Global Cancer Trial Database for multiple primary lung cancer