Symptoms and General Pathology

All Conditions

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Recurrence

Carcinoma

Carcinoma, Neuroendocrine

Adenocarcinoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell

Lung Neoplasms

Neuroendocrine Tumors

Adenocarcinoma of Lung

Carcinoid Tumor

Carcinoma, Large Cell

Adenocarcinoma, Bronchiolo-Alveolar

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neoplasms, Squamous Cell

Neuroendocrine Tumor

Lung Adenocarcinoma

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Immunomodulating Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patients undergo stereotactic body radiation therapy over 1-2 weeks.

Patients undergo stereotactic body radiation therapy over 1-2 weeks. Beginning within 36 hours before or after the first fraction of stereotactic body radiation therapy, patients also receive nivolumab IV over 30 minutes on day 1. Cycles with nivolumab repeat every 4 weeks for up to 12 weeks in the absence of disease progression or unacceptable toxicity.

Undergo stereotactic body radiation therapy

Stereotactic Body Radiation Therapy

Joe Y Chang

This phase II trial studies how well stereotactic body radiation therapy with or without nivolumab works in treating patients with stage I-IIA non-small cell lung cancer or cancer that has come back. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving stereotactic body radiation therapy and nivolumab may work better at treating non-small cell lung cancer.

PRIMARY OBJECTIVE:

I. Event-free survival (EFS), with events defined as local recurrence, regional recurrence, distant metastasis, secondary malignancy (including lung cancer), and death.

SECONDARY OBJECTIVES:

I. Overall survival (OS). II. Toxicity related to stereotactic body radiation therapy (stereotactic ablative body radiation therapy \[SABR\]) and immunotherapy.

III. Exploratory analyses of potential predictive markers and immunologic mechanisms of action.

EXPLORATORY/TRANSLATIONAL RESEARCH OBJECTIVES:

I. Identify candidate tumor-associated antigens or genes that elicit cellular and humoral immune responses in serum samples (with Immunotherapy Platform).

II. Assess PDL1 expression in tumor biopsy specimens (with Department of Pathology).

III. Identify potential radiomics features from positron emission tomography (PET)/computed tomography (CT) or magnetic resonance imaging (MRI) scans that may predict treatment response and toxicity (with Department of Radiation Physics).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo stereotactic body radiation therapy over 1-2 weeks.

ARM II: Patients undergo stereotactic body radiation therapy over 1-2 weeks. Beginning within 36 hours before or after the first fraction of stereotactic body radiation therapy, patients also receive nivolumab intravenously (IV) over 30 minutes on day 1. Cycles with nivolumab repeat every 4 weeks for up to 12 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for up to 3 years, then annually thereafter.

Stereotactic Body Radiation Therapy With or Without Nivolumab in Treating Patients With Stage I-IIA or Recurrent Non-small Cell Lung Cancer

Phase II Randomized Clinical Trials Comparing Immunotherapy Plus Stereotactic Ablative Radiotherapy (I-SABR) Versus SABR Alone for Stage I, Selected Stage IIa, or Isolated Lung Parenchymal Recurrent Non-Small Cell Lung Cancer: I-SABR

Will be estimated using Kaplan-Meier method. The stratified log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Stratified Cox proportional hazards model will be utilized to include multiple covariates in the time-to-event analysis.

Will be summarized by frequency tables. The association between the types and severity of toxicity and the treatment groups will be evaluated. No formal statistical testing will be performed on these summary data.

M.D. Anderson Cancer Center

Behaviors and Mental Disorders

Quality of Life

Gastro-enteropancreatic Neuroendocrine Tumor

Patients diagnosed with lung or gastrointestinal neuroendocrine tumors

Michael O'Rorke, PhD

With so many therapeutic options available (i.e.: biologic therapy, liver directed therapy, radiotherapy and chemotherapy), the purpose of this project is to partner with patients on comparative effectiveness research (CER) to achieve the goal of alleviating undue toxicity, and optimizing effectiveness and sequencing of therapy for neuroendocrine tumors (NET) patients. We will conduct a study of all newly occurring GEP-NET and lung NET cases aged 18 years and older diagnosed between 01/01/2018 through 12/31/2023 across 14 sites participating in the National Patient-Centered Clinical Research Network (PCORnet), enrolling an average of 215 patients per site over the 3 year study period (\~3,000 patients total), allowing up to 60 months of follow-up for medical record outcomes. Participants will complete four online or paper surveys over 18 months; these surveys will focus on patient-reported outcomes, including questions on quality of life, treatment decisions, and experiences with cancer care. Survey data will be linked to participant medical record data to achieve study aims.

NETs are a group of neoplasms that occur most frequently in the gastrointestinal tract, pancreas and the lungs, collectively referred to as gastroenteropancreatic (GEP-NETs) and lung-NETs. There are currently fewer than 180,000 patients living with this condition in the United States, meeting the criteria for rare disease status. NETs are typically slow growing, with vague signs and a myriad of symptoms (carcinoid syndrome) leading to diagnostic delays. Thus, NET patients typically experience a prolonged clinical course with active disease, and many have significant symptom burdens. However, assessment of quality of life outside of therapy trials remains scarce and of poor quality. What's more, over half of GEP-NETs are diagnosed with spread of their disease at diagnosis and are not candidates for curative surgery. Fortunately, many of these tumors are amenable to long-term medical treatment with somatostatin analogues (SSAs)- which slow down the production of hormones, especially serotonin, which helps to control the symptoms of carcinoid syndrome. However, living with distant spread of the disease increases the probability for the disease to progress. Following failure of first-line SSA therapy there are no clear consensus guidelines as to the optimum sequencing of other therapeutic options. NET patients are left wondering not only 'what therapy would be best to try next?', but 'if I were to take this option now, what treatment options will be closed off to me in the future?' and clinicians are unsure as to how best to tailor treatment selection on the characteristics of the patient and their tumor.

There is currently no large nationally recruiting prospective (forward in time) observational study of NET patients. Our large study will robustly generate real-world evidence on the frequency and sequence of commonly used treatments for GEP and lung NET patients in relation to Patient Reported Outcomes (PROs) and survival/progression, endpoints that matter most to NET patients, their caregivers, and clinicians involved in their care. Given the lack of consensus guidelines as to the optimum sequencing of treatments, evidence generated in this study will aid patient (and clinician) navigation and selection of the next most appropriate therapy, accounting for the preferences and needs of the individual patient, whilst respecting the underlying profile of their tumor. Moreover, the infrastructure this study will generate (i.e.: electronic identification of NET patients, entry and completion of tumor table data in PCORnet, and a unique NET patient health record portal), will foster future CER studies in NETs and other rare diseases.

The four specific aims of this project are:

1. To describe the frequency of treatment regimens received by line of therapy, and examine their association with symptom burden and changes in 6, 12 and 18 month health-related quality of life (HRQoL) outcomes. The influence of patient preferences, beliefs, attitudes, and experience of care on choice of these treatment regimens will also be examined.
2. To examine the association of patient, clinical, and tumor characteristics on the selection of first-line and beyond treatment regimens and compare the effects of common treatment sequences on frequency of subsequent treatments received and outcomes of overall survival and disease progression.
3. To compare the effectiveness of peptide receptor radionuclide therapy (PRRT) regimens on outcomes of renal toxicity, disease progression, and patient-reported symptoms and HRQoL.
4. To disseminate lessons learned and expand enrollment of the prospective cohort to patient advocate organizations, and to use the infrastructure developed to aid in the study of other rare diseases.

Neuroendocrine Tumors - Patient Reported Outcomes

A Cohort Study of Symptom Burden and Therapeutic Selection in Neuroendocrine Tumors (NETs)

De-identified individual participant data (IPD) will be made available to researchers and details will be provided.

Incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease. Responses to the QLQ-C30 will be linearly transformed to a 0-100 scale using EORTC guidelines, a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.

The QLQ-GINET21 contains a total of 21 items: four single-item assessments relating to muscle and/or bone pain (MBP), body image (BI), information (INF) and sexual functioning (SX), together with 17 items organized into five proposed scales: endocrine symptoms (ED; three items), GI symptoms (GI; five items), treatment-related symptoms (TR; three items), social functioning (SF) of the new module (SF21; three items) and disease-related worries (DRW; three items). Responses to the QLQ-GINET21 will be linearly transformed to a 0-100 scale using EORTC guidelines, with higher scores reflecting more severe symptoms.

Ordering of treatment receipt i.e.: first-line, 2nd line 3rd line therapies

13 items to assess cancer care as described at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2953972/

Incident acute renal failure, dialysis and liver failure during follow-up

Common Data Model (CDM) diagnosis codes for acute renal failure and dialysis

Creatinine clearance loss (per/Yr) 177Lu vs 90Y

Creatinine clearance loss (per/Yr) GEP-NETs vs lung NETs and G3

Allina Health System

Medical College of Wisconsin

University of Kansas Medical Center

University of Texas Southwestern Medical Center

University of Utah

University of Florida

Ohio State University

University of Michigan

University of Pittsburgh Medical Center

Medical University of South Carolina

University of North Carolina, Chapel Hill

Vanderbilt University Medical Center

Mayo Clinic

Northern California CarciNET Community

Neuroendocrine Cancer Awareness Network

Neuroendocrine Tumor Research Foundation

Healing NET Foundation

Patient-Centered Outcomes Research Institute

University of Iowa

Assistant Professor

Anti-Infective Agents

Everolimus

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

RAD001

Novartis Pharmaceuticals

The present study is designed to collect safety/tolerability data and explore the efficacy of RAD001 in advanced pulmonary neuroendocrine tumor in Chinese patients.

Safety and Efficacy of RAD001 in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor

A Phase Ib, Open-label Study to Evaluate RAD001 as Monotherapy Treatment in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor

Fluorides

Fluorodeoxyglucose F18

Somatostatin

Lutetium Lu 177 dotatate

Deoxyglucose

Radiopharmaceuticals

Antimetabolites

Antiviral Agents

Patients receive lutetium Lu 177 dotatate IV over 30-40 minutes on day 1 of each cycle. Treatment repeats every 56 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET during screening. Patients also undergo CT or MRI during screening and on the trial as well as FDG PET and SPECT on the trial. Additionally, patients undergo blood and tissue sample collection during screening and on the trial.

Patients receive everolimus PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may be able to cross-over to Arm I. Patients undergo PET during screening. Patients also undergo CT or MRI during screening and on the trial as well as FDG PET and SPECT on the trial. Additionally, patients undergo blood and tissue sample collection during screening and on the trial.

Undergo blood and tissue sample collection

Biospecimen Collection

Computed Tomography

Fludeoxyglucose F-18

Lutetium Lu 177 Dotatate

Positron Emission Tomography

Single Photon Emission Computed Tomography

Site Public Contact

Andrew E. Hendifar

Joshua Lukenbill

Thomas A. Hope

Jennifer A. Chan

Thorvardur R. Halfdanarson

Sukhmani K. Padda

Liza C. Villaruz

Heloisa P. Soares

Thomas A Hope

This phase II trial studies the effect of lutetium Lu 177 dotatate compared to the usual treatment (everolimus) in treating patients with somatostatin receptor positive bronchial neuroendocrine tumors that have spread to other places in the body (advanced). Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. Lutetium Lu 177 dotatate may be more effective than everolimus in shrinking or stabilizing advanced bronchial neuroendocrine tumors.

PRIMARY OBJECTIVE:

I. To compare progression-free survival (PFS) of receiving lutetium Lu 177 dotatate to that of receiving everolimus in patients with bronchial neuroendocrine tumor (NET).

SECONDARY OBJECTIVES:

I. To compare the overall survival (OS) of receiving lutetium Lu 177 dotatate versus everolimus in patients with bronchial NET.

II. To compare the overall response rate (ORR) associated with lutetium Lu 177 dotatate versus everolimus in patients with bronchial NET.

III. To evaluate and compare the toxicity profile of lutetium Lu 177 dotatate and everolimus.

EXPLORATORY OBJECTIVES:

I. To study late toxicities of lutetium Lu 177 dotatate therapy including renal dysfunction, myelodysplastic syndrome, and acute leukemia.

II. To study the impact of pretreatment disease burden, somatostatin receptor status on lutetium Lu 177 dotatate (DOTATATE) positron emission tomography (PET) (or other somatostatin receptor \[SSTR\]-PET), and measured dosimetry of response.

III. To evaluate the response rate (RR) and other efficacy parameters in typical and atypical carcinoid based on central retrospective pathology review.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive lutetium Lu 177 dotatate intravenously (IV) over 30-40 minutes on day 1 of each cycle. Treatment repeats every 56 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo positron emission tomography (PET) during screening. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) during screening and on the trial as well as fludeoxyglucose F-18 (FDG) PET and single photon emission computed tomography (SPECT) on the trial. Additionally, patients undergo blood and tissue sample collection during screening and on the trial.

ARM II: Patients receive everolimus orally (PO) once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may be able to cross-over to Arm I. Patients undergo PET during screening. Patients also undergo CT or MRI during screening and on the trial as well as FDG PET and SPECT on the trial. Additionally, patients undergo blood and tissue sample collection during screening and on the trial.

After completion of study treatment, patients are followed up every 3 months until disease progression and then every 6 months for up to 5 years following study registration.

Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors

Randomized Phase II Trial of Lutetium Lu 177 Dotatate Versus Everolimus in Somatostatin Receptor Positive Bronchial Neuroendocrine Tumors

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

The incidence of grade 3+ late toxicities will be analyzed in a descriptive manner. Incidence will be described for each treatment arm. Frequency tables will be reviewed for patterns.

The proportion of patients in each carcinoid group with either CR or PR as their best response will be estimated using point estimates and 95% CIs according to the methods in Duffy and Santner. ORR will be compared between treatment arms using the 2-sample z-test to compare sample proportion at a one-sided 5% level of significance.

Will be compared between patients with a bronchial neuroendocrine tumor (NET) receiving lutetium Lu 177 dotatate to those receiving everolimus. The distribution of PFS will be estimated using the Kaplan Meier method. Will be tested using a one-sided stratified log rank test. The median PFS, along with 90% confidence intervals (CIs), will be estimated for the two treatment groups.

The distribution of OS will be estimated using the method of Kaplan-Meier. The median OS, along with 90% CIs, will be estimated by the two treatment groups. OS will be compared between the two between treatment arms using the stratified log-rank test at a one-sided 10% level of significance.

Defined as the proportion of patients in each arm whose best response is either complete response (CR) or partial response (PR). Will be estimated using point estimates and 95% CIs according to the methods in Duffy and Santner.

Will evaluate and compare the toxicity profile of lutetium Lu 177 dotatate and everolimus. As per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0, the term toxicity is defined as adverse events that are classified as either possibly, probably, or definitely related to the study treatment.

National Cancer Institute (NCI)

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Pancreatic Cancer

Participants with histologically or cytologically proven diagnosis of any grade, any stage NET of gastroenteropancreatic (GEP) or lung origin; In the first stage of the study (initial 50 patients) only potential participants with stage IV, well-differentiated tumors (G1/G2) will be enrolled.

Participants with histologically or cytologically proven diagnosis of any grade, any stage gastrointestinal (GI) malignancies.

5 mL of blood will be drawn from participants for testing.

NETest

Jonathan Strosberg, M.D.

The purpose of this study is to evaluate how well an investigational blood test performs. The study will look at the sensitivity and specificity of a blood-based multitranscriptome assay (NETest).

Clinical Utility Assay as a Biomarker for Gastroenteropancreatic and Lung Neuroendocrine Tumors

The Clinical Utility of a Blood-Based Multitranscriptome Assay as a Biomarker for Gastroenteropancreatic and Lung Neuroendocrine Tumors

Investigators have designed the study to test the null hypothesis that the NETest has a sensitivity and specificity of 70% or less in NET patients. The sample size calculation has been based on the assumption that a sensitivity and specificity of greater than 90% would generate further interest in the test for unselected NET patients. Power and type 1 error will be 99% and 5% respectively. Under this model, 80 or more positive tests in the cohort of 100 patients with NETs would lead to the rejection of the null hypothesis, suggesting that the NETest is sensitive. Likewise, 80 or more negative tests in 100 patients without NETs will suggest that NETest is specific. An interim analysis will be performed to rule out the futility of the NETest. Futility will be defined as a rate of false positive or false negative \>25%. Hence, if 12 or more false positives or negatives are observed among the first 50 participants, the study will be suspended, pending review by the investigators.

H. Lee Moffitt Cancer Center and Research Institute

Temozolomide

Sunitinib

Antineoplastic Agents, Alkylating

Alkylating Agents

All patients will receive:

* Cabozantinib 40 mg os QD
* Temozolomide 100 mg/m2/day seven days followed by seven days of stop (regimen one week on / one week off).

Patients enrolled will receive study medication until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever comes first.

Patients will be required to attend clinic on Day 1, Day 8, Day 14 and Day 22 of every 4 week cycle.

Patients will return to clinic at 30 days (+/- 5 days) of their last dose of cabozantinib or temozolomide (whichever is discontinued last), for an end of treatment visit.

Following their end of treatment visit patients will be followed-up 3-monthly during routine clinic appointments to collect data on further anti-cancer treatment and survival. Follow-up will continue until 6 months after the last patient stops study treatment or up to 18 months after the last patient is randomised, whichever is sooner.

Cabozantinib and Temozolomide

Salvatore Tafuto, MD

National Cancer Institute of Naples o Naples, MD

The aim of CABOTEM study is to demonstrate the safety and activity of the Cabozantinib and Temozolomide combination in Lung and GEP-NENs patients, progressing after a first line therapy, including target therapies (everolimus, sunitinib) and / or chemotherapy, in the approved setting.

Neuroendocrine neoplasms (NENs) are a heterogeneous group of neoplasms, mainly originating from the gastro-entero-pancreatic system and the lung. Molecular targeted therapy of NENs with the mTOR inhibitor everolimus is currently approved for GEP-Lung NENs and with the multi-tyrosine kinase inhibitor (multiTKI) sunitinib (VEGFR, PDGFR, KIT) for PAN-NENs. There is still an unmet need for further medical therapies including novel targeted therapies, the knowledge of the data on the role of the sequences of the therapies and the definition of new biological predictors of outcome and prognosis.

Cabozantinib targets VEGF receptors, MET, AXL, and RET. Cabozantinib is an oral, potent inhibitor of mesenchymal-epithelial transition factor (MET), VEGF receptor 2 (VEGFR2), and RET that produces robust antiangiogenic, antiproliferative, and antiinvasive effects in preclinical models. It has been shown to improve outcomes in advanced renal cell carcinoma patients in both the first-line and second-line settings and is also approved for progressive, metastatic medullary thyroid cancer.

Recent studies have suggested that activation of the MET signalling pathway may also play a role in the growth of neuroendocrine tumours. Increased expression of MET correlates with decreased overall survival in pancreatic neuroendocrine tumours. In preclinical pancreatic neuroendocrine tumour models, various multi-TKIs with combined anti-VEGF and anti-MET efficacy have shown enhanced angiogenesis inhibition, as well as suppression of tumour invasion and metastasis . Given the strong theoretical rationale for combining anti-VEGF and anti-MET activity in neuroendocrine tumours, in USA will start randomized, double-blinded phase III trial, named CABINET to evaluate the effects in terms of PFS in patients with advanced neuroendocrine tumours after progression on everolimus.

In an on-going clinical trial, Chan et al. showed, in patients with progressive, well differentiated, grade 1-2 carcinoid and treated with cabozantinib 60 mg po qd and without limit to prior therapy, 21.8 mo (95% CI, 8.5-32.0 mo) of mPFS in pts with pNET and 31.4 mo (95% CI, 8.5 mo-NR) in pts with carcinoid . In this study pNET achieved PR (ORR 15%, 95% CI 5-36%); 15/20 had SD. 6/41 pts with carcinoid achieved PR (ORR 15%, 95% CI 7-28%); 26/41 had SD.

The front-line treatment of advanced NENs depends on many clinical and pathological factors but there are no standard second-line therapies when the disease progress. Although data for temozolomide (TMZ)-based chemotherapy are still evolving, this treatment may replace STZ-based regimens in PAN-NENs due to its better tolerability and side effect profile. In addition, there is evidence that TMZ could also be used in the subgroup of well-differentiated G3 NETs. There is less clear-cut evidence of a benefit for chemotherapy in intestinal NETs, but still evolving data suggest that TMZ may be efficacious in particular patients. In our experiences, an intermittent schedule of metronomic TMZ is effective and safe in patients with advanced progressive G2-G3 NEN, showing to be a feasible second line treatment in this setting. This schedule has been also investigated by Chan et al. in 34 patients with advanced neuroendocrine tumors demonstrating a good safety profile. D.Shiff et al. demonstrated that cabozantinib at a dose of 40/60 mg daily plus TMZ for patients with newly diagnosed high-grade glioma was generally well tolerated even with the addition of radiotherapy, and also demonstrated no pharmacokinetic interactions with concurrent TMZ. Both mRNA and protein levels of c-Met were significantly associated with tumour grade progression and inversely correlated with overall and progression-free survival in high-grade gliomas. c-Met seems an independent prognostic marker in glioblastoma patients and further analysis in vitro revealed that downregulating the expression of c-Met dramatically inhibited cell migration and invasion capacities, enhanced sensitivity to TMZ chemotherapy . Cabozantinib downregulating c-MET pathway can induce, in addition to antiangiogenic and antiproliferative effects, also an increased sensitivity to Temozolomide.

A Trial Evaluating the Activity and Safety of Combination Between Cabozantinib and Temozolomide in Lung and GEP-NENS Progressive After Everolimus, Sunitinib or PRRT (CABOTEM)

A Phase II Single Arm Interventional Trial Evaluating the Activity and Safety of Combination Between Cabozantinib and Temozolomide in Lung and GEP-NENS Progressive After Everolimus, Sunitinib or PRRT (CABOTEM)

Overall Response Rate (ORR) (as assessed by RECIST v1.1) defined by complete response (CR) or partial response (PR).

PFS (as assessed by RECIST v1.1) defined as time from study entry to first evidence of disease progression or death due to any cause.

CBR (as assessed by RECIST v1.1) defined by complete response (CR) or partial response (PR) or stable disease (SD).

OS defined as time from study entry to death due to any cause or to study termination

DOR defined as time from study entry to change in response from CR or PR to Stable Disease (SD) or Progressive Disease (SD) (as assessed by RECIST v1.1).

Safety and tolerability as assessed by adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

After five patients, it will be perform a detailed safety report based on CTCAE v.5.0

MGMT Methylation Status will be assessed and any correlation with the efficacy endpoints will be evaluated.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Stereotactic Body Radiation Therapy With or Without Nivolumab in Treating Patients With Stage I-IIA or Recurrent Non-small Cell Lung Cancer	NCT03110978	Lung Atypical C... Lung Neuroendoc... Lung Non-Small ... Minimally Invas... Neuroendocrine ... Recurrent Lung ... Recurrent Lung ... Recurrent Lung ... Stage I Lung Ca... Stage IA1 Lung ... Stage IA2 Lung ... Stage IA3 Lung ... Stage IB Lung C... Stage IIA Lung ...	Nivolumab Stereotactic Bo...	18 Years -	M.D. Anderson Cancer Center
Neuroendocrine Tumors - Patient Reported Outcomes	NCT05064150	Neuroendocrine ... Gastroenteropan... Lung Neuroendoc... Neuroendocrine ...		18 Years -	University of Iowa
Safety and Efficacy of RAD001 in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor	NCT01324492	Lung Neuroendoc...	RAD001	18 Years - 80 Years	Novartis
Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors	NCT04665739	Advanced Lung N... Functioning Lun... Locally Advance... Lung Neuroendoc... Lung Neuroendoc... Lung Neuroendoc... Metastatic Lung... Metastatic Lung... Non-Functioning... Recurrent Lung ... Unresectable Lu... Unresectable Lu...	Biospecimen Col... Computed Tomogr... Everolimus Fludeoxyglucose... Lutetium Lu 177... Positron Emissi... Single Photon E...	18 Years -	National Cancer Institute (NCI)
Clinical Utility Assay as a Biomarker for Gastroenteropancreatic and Lung Neuroendocrine Tumors	NCT02948946	Gastroenteropan... Lung Neuroendoc...	NETest	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
A Trial Evaluating the Activity and Safety of Combination Between Cabozantinib and Temozolomide in Lung and GEP-NENS Progressive After Everolimus, Sunitinib or PRRT (CABOTEM)	NCT04893785	Lung Neuroendoc... GEP Neuroendocr...	Cabozantinib an...	18 Years -	National Cancer Institute, Naples
Safety and Efficacy of RAD001 in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor	NCT01324492	Lung Neuroendoc...	RAD001	18 Years - 80 Years	Novartis
Neuroendocrine Tumors - Patient Reported Outcomes	NCT05064150	Neuroendocrine ... Gastroenteropan... Lung Neuroendoc... Neuroendocrine ...		18 Years -	University of Iowa

Spots Global Cancer Trial Database for lung neuroendocrine neoplasm