Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Immunomodulating Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patients receive prior to surgery (lobectomy) SABR.

Patients receive prior to surgery (lobectomy) SABR + 2 rounds of pembrolizumab

Prior to surgery (lobectomy), patients receive stereotactic ablative radiotherapy.

SABR

Prior to surgery (lobectomy), patients receive stereotactic ablative radiotherapy + 2 rounds of pembrolizumab

SABR + pembrolizumab

Eveline A van de Stadt, MD

Anna-Larissa N Niemeijer, MD

E.F. Smit, MD, PhD

A.J. de Langen, MD, PhD

This study aims to evaluate the safety and mechanisms of action of the trimodality treatment (radiotherapy, immunotherapy and surgery) in early-stage non-small cell lung cancer. Half of the patients will receive stereotactic ablative radiotherapy followed by 2 cycles of immunotherapy (pembrolizumab); the other half will not receive the immunotherapy treatment. After treatment, both groups will continue treatment according to guidelines and will undergo surgery (lobectomy).

An open label randomized exploratory study of the safety and mechanisms of action of combined treatment with SBRT and immunotherapy (pembrolizumab, anti-PD1) for early stage NSCLC.

Intervention:

Patients will be randomized between SBRT with or without 2 cycles of pembrolizumab treatment (starting on the first day of radiotherapy). The patients will undergo a lobectomy with hilar and mediastinal lymph node dissection after SBRT +/- pembrolizumab treatment. Translational research to explore the immune mechanism of action will include biological imaging with immuno-PET (positron emission tomography). Expression rates and activation states of immune effector subsets will be assessed in tumor core biopsy specimens, peripheral blood and tumor draining lymph nodes (TDLNs) by means of fine needle aspirates of TDLNs.

Main study parameters/endpoints:

To assess the safety of combined SBRT and pembrolizumab treatment in early stage NSCLC and to identify the immunological mechanism of action.

Combining SBRT and Immunotherapy in Early Stage NSCLC Patients Planned for Surgery

Combining SBRT and Immunotherapy in Early Stage NSCLC Patients Planned for Surgery: Exploring Safety and Immunological Proof of Principle.

Safety of the combination of SBRT and pembrolizumab will be assessed by the percentage of ≥3 pneumonitis. When combined SBRT and pembrolizumab treatment results in NCIC-CTC grade ≥3 pneumonitis in ≤10% of patients, the combination is regarded as safe. Serious adverse events will be recorded to assess both incidence and severity.

PD-1 expression in tumor tissue, tumordraining lymphnodes and peripheral blood.

PD-L1 expression in tumor tissue, tumordraining lymphnodes and peripheral blood.

CD4 expression in tumor tissue, tumordraining lymphnodes and peripheral blood.

CD8 expression in tumor tissue, TDLN's and peripheral blood.

FoxP3 expression in tumor tissue, tumordraining lymphnodes and peripheral blood.

Ki67 expression in tumor tissue, tumordraining lymphnodes and peripheral blood.

Cell count of the individual immune cells in tumordraining lymphnodes and non-tumordraining lymphnodes

SUVmax will be measured in all tumor lesions, enlarged lymph nodes and liver, kidneys, lungs, spleen and left ventricle of the heart.

SUVpeak will be measured in all tumor lesions, enlarged lymph nodes and liver, kidneys, lungs, spleen and left ventricle of the heart.

SUVmean will be measured in all tumor lesions, enlarged lymph nodes and liver, kidneys, lungs, spleen and left ventricle of the heart.

The pre- and post SBRT +/- pembrolizumab CT scans will be assessed for HU density and f-air values

The pre- and post SBRT +/- pembrolizumab CT scans will be assessed for and f-air values

The data of the PET-scan will be analyzed and compared to the blood and tissue samples to find a correlation between findings.

SUV are values used to describe PET-data. irAE's are specific adverse events. This outcome aims to correlate the (possible) irAE's with the PET-data.

Amsterdam UMC, location VUmc

Surgeries

jianxing He, President

wenhua Liang, Director

Chao Lv, Deputy Director

Zitong Wang, Director

Naixin Liang, Deputy Director

Fan Yang

Shaohua Ma, Director

Yi Zhang, Director

Zhiqiang Wang

Xiaojie Pan, Deputy Director

Jian Zhao, Director

Guibin Qiao, Director

Jianxing He, President

Jianjun Lu, Director

Lin Yang, Deputy Director

Jie Chen, Deputy Director

Lei Xian, Director

Fanyi Kong

Junfeng Liu, Director

Mingfei Geng, Director

Li Wei, Director

Yongde Liao

Chunfang Zhang, Director

Liang Chen, Director

Xiaoqiang Liu, Deputy Director

Haitao Ma, Director

Bentong Yu, Director

Dongliang Yu, Director

Wei Liu, Director

Hua Xin, Director

Changhong Liu

Suning Zhang, Director

Shun Xu, Director

Zhiyong Su, Director

Zhanlin Guo, Director

Hui Tian

Baijiang Zhang, Director

Zeshu Li, Director

Hecheng Li, Director

Xiaoqing Zhao

Songtao Xu, Deputy Director

Hongguang Zhang

Lunxu Liu, Vice President

Tianyang Dai

Xun Zhang

Jun Chen, Director

Zhengfu He

Jian Hu, Director

Ying Chai, Director

Qixun Chen, Director

Weiyu Shen, Director

Guangmao Yu

Baofu Chen

This study is a prospective, national, multi-center, non-interventional study. The main purpose is to explore the initial adjuvant treatment pattern after radical resection for early-stage NSCLC patients with EGFR Mutation-Positive in the real world. The secondary purpose was to observe the postoperative follow-up treatment pattern and its subgroups (based on different EGFR mutation status and different clinical stages).

About 2,000 eNSCLC patients who received radical resection from about 50 research centers across the country will be included in this study, and will be followed up to 2 years after enrollment according to the actual clinical situation. The analysis method of this study is mainly based on descriptive statistics. The information about the human genetic resources of the subjects to be collected includes: demography, physical examination, WHO fitness status, medical history, smoking history, disease characteristics, surgical information, initial and follow-up adjuvant treatment pattern, laboratory tests, survival status, and adverse events related to gefitinib/osimertinib, serious adverse events/non-severe ADR, measures taken for adverse events, outcome of adverse events.

A Real-world Study of Adjuvant Therapy in Early Stage NSCLC With EGFR Mutation-Positive in China

A Prospective, National, Multi-center, Non-intervention Real-world Study of Adjuvant Therapy in Early Stage NSCLC With EGFR Mutation-Positive in China

Descriptive summary statistics ( total number of cases, number of missing cases, frequency, and percentage of each category) were used to describe the distribution of participants with initial adjuvant treatment patterns, including chemical, targeted, combined, or other therapy.

Set subgroup analysis for different initial adjuvant treatment pattern, including different clinical stages (according to phase I/ Phase II/ stage III) and different EGFR mutation status (19del or 21 L858R);

Calculate the time from the start date to the end of initial adjuvant treatment. The total number of cases, number of missing cases, mean, standard deviation, median, 25th and 75th percentiles, minimum and maximum were used for statistical description.

Calculate the interval of operation to the adjuvant therapy with EGFR-TKI, which is classified into single-drug therapy and combined therapy. The total number of cases, number of missing cases, mean, standard deviation, median, 25th and 75th percentiles, minimum and maximum were used for statistical description.

The patients with chemotherapy were mainly calculated, divided into chemotherapy and targeted combination chemotherapy. The total number of chemotherapy cycles, the number of missing cases, the mean, standard deviation, the median, the 25th and 75th percentiles, the minimum and the maximum were statistically described

Descriptive summary statistics ( total number of cases, number of missing cases, frequency, and percentage of each category) were used to describe the distribution of participants with follow-up treatment patterns after advanced events evaluated by an investigator, including chemical, targeted, combined, or other therapy.

Set subgroup analysis for different follow-up treatment pattern including different clinical stages (according to phase I/ Phase II/ stage III) and different EGFR mutation status (19del or 21 L858R);

Calculate the time from the start date to the end of follow-up treatment. The results are shown in months, to one decimal place. The total number of cases, number of missing cases, mean, standard deviation, median, 25th and 75th percentiles, minimum and maximum were used for statistical description.

Calculate the interval of operation to the follow-up treatment with EGFR-TKI, which is classified into single-drug therapy and combined therapy. The results are shown in months, to one decimal place. The total number of cases, number of missing cases, mean, standard deviation, median, 25th and 75th percentiles, minimum and maximum were used for statistical description.

The patients with chemotherapy of follow-up treatment were mainly calculated, divided into chemotherapy and targeted combination chemotherapy. The total number of chemotherapy cycles, the number of missing cases, the mean, standard deviation, the median, the 25th and 75th percentiles, the minimum and the maximum were statistically described

The First Affiliated Hospital of Guangzhou Medical University

Clinical Professor

Durvalumab

durvalumab 1500 mg i.v. every fourth week for 12 months

Andreas Hallqvist, PhD

Annika Baan

Anu Anttonen

Tanja Skyttä

Maria Silvoniemi

Antti Jekunen

Åslaug Helland

Nina Helbekkmo

Bjørn Henning Grønberg

Øyvind Yksnøy

Hirsch Koyi

Anders Wikström

Lina Lindberg

Maria Planck, Ass. prof.

Luigi De Petris, PhD

Mikael Johansson, Ass. Prof.

This is a randomized multicentre open label phase II study of Durvalumab following Stereotactic Body Radiotherapy (SBRT) in patients with T1-2N0M0 NSCLC.

Patients will be randomized 1:1 to follow up or receiving Durvalumab every 4th week for 12 months

This is a randomized multicentre open label phase II study of the PDL1 inhibitor Durvalumab following SBRT in patients with T1-2N0M0 NSCLC. It will enroll 106 patients aiming at a minimum of 5 subjects per site. The subjects will be randomized in a 1:1 fashion with performance status, gender and T-stage as stratification factors. Patients with peripheral lung tumors will receive SBRT usually between 3 and 4 fractions. The group randomized to immunotherapy will then receive Durvalumab, given with a fixed dose of 1500 mg i.v. every fourth week during 12 months. Both arms will be assessed according to the same follow-up schedule with radiology every third month.

Ablative STEreotactic RadiOtherapy wIth Durvalumab (MEDI4736)

Ablative STEreotactic RadiOtherapy wIth Durvalumab (MEDI4736). An Open Label Randomized Phase II Trial With Durvalumab Following Stereotactic Body Radiotherapy (SBRT) in Patients With Stage I Non-small Cell Lung Cancer (NSCLC)

Time to progression related to level of PDL1expression

AstraZeneca

Vastra Gotaland Region

Principal Investigator

NSCLC patients,including stage I to stage IV.

Without intervention,this study is just an observational study.

without intervention type

dong xiaorong, Dr

Relationship between human microbiota and epidemiology of lung cancer

In this study,We aim to find some kinds of human microbiota , which were associated with development of non-small cell lung cancer.

We intend to collect the following samples：

1. Blood samples
2. Stool samples
3. Sputum samples
4. Tumor tissue samples

The Role of Microbiota on the Development of Lung Cancer

Find some human microbes that are associated with the development of lung cancer, we can detect these human microbiological content as a biomarker of lung cancer.

Xiaorong Dong

Professor

Patients in the lung segment group underwent anatomical segmental resection surgery, including subsegmental resection of the lung Patients in the lung segment group underwent anatomical segmental resection surgery, including subsegmental resection of the lung It is recommended to perform intraoperative lymph node sampling and rapid pathological examination (not mandatory). If lymph node metastasis is found during the surgery, the surgery must be switched to lobectomy. Lymph node sampling, selective lymph node dissection, or systematic lymph node dissection can also be used.

Segmentectomy

Lobectomy

xiaolong yan

The early NSCLC（Non-small cell lung cancer） patients with partial solid nodules mainly composed of solid components, whose maximum tumor diameter was ≤ 2.0cm and 0.5\<CTR（Consolidation tumor ratio）\<1, as indicated by preoperative thin slice CT, were selected as the study objects. The short-term and long-term effects of segmental resection and lobectomy under Thoracoscopy were compared to provide high-level evidence for the selection of surgical treatment methods for early NSCLC.

Since Cahan reported on "radical lobectomy" in 1960, lobectomy has become the standard surgical method for lung cancer, and its efficacy has long been verified in clinical practice. In 2006, the National Comprehensive Cancer Network (NCCN) lung cancer diagnosis and treatment guidelines listed thoracoscopic lobectomy as one of the standard surgical methods for early non-small cell lung cancer (NSCLC) for the first time. However, in recent years, an increasing number of retrospective studies have found that the efficacy of subpulmonary lobectomy in treating stage IA NSCLC is similar to that of lobectomy. Not only is there no difference in survival rate, but perioperative complications and mortality are lower, and lung function is also more protected. Anatomical segmental lung resection was also recommended as one of the surgical options for early NSCLC patients by the US NCCN guidelines in 2010. With the development of thin-layer CT diagnosis and treatment technology, the detection rate of early lung cancer with main imaging manifestations such as small pulmonary nodules and ground glass nodules (GGO) has improved. The solid components in GGO are often considered as infiltrating components with a high possibility. The Lung Cancer Surgery Research Group (LCSSG) of the Japanese Clinical Oncology Group used Solid Component Ratio for ground glass nodules, which stratified the study population by the ratio of the maximum solid component diameter to the maximum tumor diameter, and began multiple clinical trials related to subpulmonary lobectomy, And these clinical trials will clarify whether subpulmonary lobectomy can be used as a standard surgical procedure for early NSCLC patients.

Among them, the recently released research results of the JCOG 0802 trial suggest that for peripheral NSCLC with tumor diameter ≤ 2cm and CTR\>0.5, the segmental resection group even outperforms the lobectomy group in terms of 5-year OS as the main endpoint, which overturns people's understanding of early lung cancer surgery methods. The JCOG 0802 results showed that the local recurrence rate in the segmental resection group was 10.5%, while in the lobectomy group it was 5.4% (p=0.0018). However, the relatively high value of local recurrence in the segmental resection group did not result in a decrease in the final 5-year RFS and 5-year OS. And in the JCOG 0201 study, the tumor size of all recurrent cases within 5 and 10 years after surgery was ≥ 1cm, and the majority were patients with CTR=1.0. However, it is worth noting that the JCOG 0802 experiment also has corresponding problems: 1. The initial enrollment condition is CTR\>0.25, and with the release of the long-term results of the JCOG 0201 experiment, the CTR value is adjusted from 0.25 to 0.5; 2. More than half of the enrolled patients have pure solid nodules (CTR=1.0); 3. During the research phase, preoperative 3D reconstruction technology was not used for surgical resection range planning. Therefore, the experimental results of JCOG 0802 deserve further in-depth research, and the choice of surgical methods for patients with partial solid nodules (PSN) with a diameter ≤ 2cm and a CTR\<1 is also the most perplexing issue for thoracic surgeons at present. Someone has proposed that for PSN patients with a diameter ≤ 2cm, subpulmonary lobectomy surgery can replace traditional lobectomy surgery, and patients have similar prognosis. However, this theory is derived from retrospective studies and there is a lack of relevant prospective randomized controlled study data, which should be confirmed in prospective studies. Therefore, the issues raised in the above research pose key scientific questions for the implementation of this project: whether segmental resection of the lung has similar long-term survival and short-term efficacy to lobectomy for patients with partial solid nodules with a tumor diameter of ≤ 2cm and 0.5\<CTR\<1 requires a multicenter, prospective, non-inferiority, randomized controlled study to answer.

In summary, based on previous literature and clinical studies, this project conducted a multicenter, prospective, open, non-inferiority, randomized controlled study in conjunction with multiple well-known hospitals in China, targeting early NSCLC patients with partial solid nodules (different from JCOG 0802, excluding solid nodules with CTR=1) with a maximum tumor diameter of ≤ 2.0cm and a maximum tumor diameter of 0.5\<CTR\<1 on preoperative thin-layer CT. The main endpoint of the study was 5-year DFS, Compare the short-term and long-term efficacy of VATS pulmonary segment resection and lobectomy in the treatment of early NSCLC. The expected results of this project will further fill the gaps in previous clinical research and provide high-level evidence for the selection of surgical treatment methods for early NSCLC. It is expected to enrich or rewrite the current surgical treatment guidelines for lung cancer, improve the level of NSCLC surgical treatment, and have important theoretical significance and practical value.

Comparison of Segmentectomy and Lobectomy in Small (2 cm or Less 0.5<CTR<1) Non-small Cell Lung Cancer: a Prospective, Multicenter Randomized Controlled Study

The official website of the Second Affiliated Hospital of the Air Force Military Medical University of PLA（http://tdwww.fmmu.edu.cn/）

Disease-free survival (DFS) is a number that tells the chances of staying free of a disease or cancer after a particular treatment. It is the percentage of individuals in the treatment group who are likely to be free of the signs and symptoms of a disease after a specified duration of time.

The time between the onset of randomization and the occurrence (progression) or death (for any reason) of the tumor.

Pulmonary function test (PFTs) are noninvasive test that show how well the lungs are working after surgery.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combining SBRT and Immunotherapy in Early Stage NSCLC Patients Planned for Surgery	NCT03446911	NSCLC, Stage I	SABR SABR + pembroli...	18 Years -	Amsterdam UMC, location VUmc
A Real-world Study of Adjuvant Therapy in Early Stage NSCLC With EGFR Mutation-Positive in China	NCT04830826	NSCLC, Stage I NSCLC, Stage II NSCLC, Stage II...	Surgeries	-	The First Affiliated Hospital of Guangzhou Medical University
Ablative STEreotactic RadiOtherapy wIth Durvalumab (MEDI4736)	NCT03446547	NSCLC, Stage I	Durvalumab	18 Years -	Vastra Gotaland Region
Combining SBRT and Immunotherapy in Early Stage NSCLC Patients Planned for Surgery	NCT03446911	NSCLC, Stage I	SABR SABR + pembroli...	18 Years -	Amsterdam UMC, location VUmc
The Role of Microbiota on the Development of Lung Cancer	NCT03454685	NSCLC, Stage I NSCLC, Stage II NSCLC, Stage II... NSCLC Stage IV Healthy Subject...	without interve...	18 Years - 70 Years	Wuhan Union Hospital, China
Comparison of Segmentectomy and Lobectomy in Small (2 cm or Less 0.5<CTR<1) Non-small Cell Lung Cancer: a Prospective, Multicenter Randomized Controlled Study	NCT06028412	NSCLC, Stage I	Segmentectomy Lobectomy	18 Years - 75 Years	Tang-Du Hospital

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