Non Small Cell Lung CancerPhase 2BRATRNCT04193007

The Role of Brain Radiotherapy in Patients With Asymptomatic Brain Metastasis in the Era of Targeted Therapy for NSCLC

A Phase 2 study testing molecular targeted therapies and Brain Radiotherapy in people with Non Small Cell Lung Cancer and Brain Metastases, run by Second Affiliated Hospital of Nanchang University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Non Small Cell Lung Cancer, Brain Metastases
What is being tested?: molecular targeted therapies and Brain Radiotherapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteChina
Study dates: 1 Dec 2019to 1 Jun 2022
Phase: Phase 2
Are there results?: None posted in the registry

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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histology confirmed that it was non-small cell lung cancer;
EGFR, ALK or ROS1 gene detection showed sensitive gene mutation, and patients were willing to receive targeted therapy;
brain MRI confirmed brain metastasis;
asymptomatic or symptomatic brain metastasis could be controlled by glucocorticoid;
PS score 0-1;
no brain radiotherapy or targeted therapy before entering the group;

Show all 10Show fewer

there was no history of malignant tumor and no serious medical diseases;
Laboratory examination: White blood cell count ≥ 4 *10^9/L, neutrophil count ≥ 2.0 *10^9, platelet count ≥ 100 *10^9, hemoglobin ≥ 10 g / L, liver and kidney function and ECG were normal;
the pregnancy test was negative within 3 days before entering the group, and agreed to use medically effective contraceptives during the experiment;
sign informed consent form.

Who cannot join

Small cell lung cancer was confirmed by pathology;
other malignant tumors (unless PFS ≥ 3 years, except non-black skin cancer);
were treated with brain radiotherapy or targeted therapy before;
those with other potentially serious diseases (congestive heart failure, transmural myocardial infarction, admission with severe acute bacterial or fungal infection, COPD or other respiratory diseases that affect treatment, etc.), Taking into account that the study may exacerbate or fail to control the disease;
severe immunosuppressive diseases, such as AIDS;
pregnant women, lactating women or women of childbearing age who do not agree with the use of effective contraception in the trial;
Intracranial metastasis with obvious symptoms or symptoms that can not be relieved by glucocorticoid alone

Trial locations and contacts

1 site in 1 country.

Liu Anwen, Phd contact

+8613767120022

awliu666@163.com

Cai Jing, Phd contact

+8615270905381

cjdl879@163.com

China1 site

The Second Afiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Anwen Liu, MD, 13767120022, awliu666@163.com

Other trials in China

About this study

Official title: A Randomized Phase II Trial of Brain Radiotherapy Combined With Targeted Therapy in Patients With Asymptomatic NSCLC Brain Metastasis With Gene Sensitive Mutation

Brain metastasis is the most common neurological complication in tumor patients, and lung cancer is the most common tumor with brain metastasis. The prognosis of patients with non-small cell lung cancer with brain metastasis is poor. If not treated, the median survival time was about 1 month, the median survival time for steroid therapy was about 2 to 3 months, and the median survival time for patients receiving whole brain radiotherapy was about 3 to 6 months. Studies have shown that the incidence of brain metastasis is not only related to tumor size, N stage and tumor cell type, but also more likely to occur in NSCLC patients with sensitive gene mutation. With the rapid development of NSCLC molecular targeted therapy and precise radiotherapy, the new main therapeutic methods for NSCLC brain metastasis in recent years include stereotactic radiotherapy for (SRT),. Based on intensity modulated technique, simultaneous modulated accelerated radiation therapy for Brain(SMART-Brain) and molecular targeted therapy were carried out. However, at present, the best treatment choice for NSCLC brain metastasis, especially for asymptomatic brain metastasis patients, is still controversial. The choice and combined application mode of individualized treatment for different patients is still a problem to be explored. Based on the synergistic effect of radiotherapy and molecular targeted therapy on the basis of cell and molecule, The purpose of this study was to prospectively compare the efficacy of radiotherapy combined with targeted therapy and targeted therapy alone in patients with asymptomatic NSCLC brain metastasis with gene sensitive mutations, and subgroup analysis of different molecular targets and mutation sites. It is expected that this study will provide a basis for optimizing the curative effect of patients with NSCLC brain metastasis.

Read the detailed description

This is a randomized phase II clinical trial. The objective of the study is to assess efficacy and safety of brain radiotherapy combined with targeted therapy and simple targeted therapy in patients with asymptomatic NSCLC brain metastasis with gene sensitive mutation. Patients were randomized with equal allocation to Molecular targeted therapy alone or with brain radiotherapy. Study therapy continued until disease progression, unacceptable adverse event, or withdrawal of consent

Conditions: Non Small Cell Lung Cancer, Brain Metastases
Being tested: molecular targeted therapies, Brain Radiotherapy
Keywords: Non Small Cell Lung Cancer, Brain Metastases
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

molecular targeted therapiesDrug
Also called Targeted Therapy, Molecular, Therapy, Molecular Targeted, Targeted Molecular Therapies
if EGFR mutation is positive, (gefitinib, ecotinib, erlotinib）or ALK/ROS-1 positive（Crizotinib）
Brain RadiotherapyRadiation
Also called Stereotactic radiotherapy,SRS, simultaneous modulated accelerated radiation therapy for Brain,SMART-Brain
SRS was used for 1-3 intracranial lesions, and simultaneous modulated accelerated radiation therapy for Brain(SMART-Brain)was used for more than 3 intracranial lesions

Study groups in NCT04193007
Study group	Role	What they receive
molecular targeted therapy group	Experimental	Molecular targeted therapy(according to the results of gene detection, targeted drugs were selected, such as EGFR mutation using the first generation of EGFR-TKI,ALK or ROS1 mutation using the first generation of ALK inhibitors) Receives: Drug: molecular targeted therapies
Brain Radiotherapy and molecular targeted therapy group	Experimental	Brain Radiotherapy (stereotactic radiotherapy was used for 1-3 intracranial lesions, and simultaneous modulated accelerated radiation therapy for Brain(SMART-Brain )was used for more than 3 intracranial lesions);Molecular targeted therapy(according to the results of gene detection, targeted drugs were selected, such as EGFR mutation using the first generation of EGFR-TKI,ALK or ROS1 mutation using the first generation of ALK inhibitors) Receives: Drug: molecular targeted therapies; Radiation: Brain Radiotherapy

What is being measured

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

Intracranial progression-free survival,iPFS-LM
Time from BM diagnosis to the first documentation of intracranial lesion progression or death with documented intracranial progression
Measured: Every 6 weeks up to 2 years
Objective Response Rate,ORR
ORR, proportion of patients with a best overall response of complete response or partial response (CR+PR)
Measured: 1 month after treatment

Secondary outcomes (3)

Progress Free Survival rate,PFS
The period from the start of treatment to the progression or death of a patient
Measured: Every 6 weeks up to 2 years
Median Survival Time,MST
the cumulative survival rate is 0.5, the corresponding survival time means that only 50% of the individuals can live through this time.
Measured: Every 6 weeks up to 2 years
adverse events
Number of patients with adverse events (AEs) as a measure of safety and tolerability
Measured: Every 6 weeks up to 2 years

Timeline

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

1 Dec 20191 Jun 2022

First posted10 Dec 2019
Study start1 Dec 2019 (estimated)
Primary completion30 Dec 2021 (estimated)
Study completion1 Jun 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Second Affiliated Hospital of Nanchang UniversityThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel Assignment
Masking: None (open label)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04193007
Sponsor's protocol ID: Y-Q201802-009
Acronym: BRATR
Status last verified: Nov 2019
First submitted: 13 Nov 2019
Last updated: 10 Dec 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Nayak L, Lee EQ, Wen PY. Epidemiology of brain metastases. Curr Oncol Rep. 2012 Feb;14(1):48-54. doi: 10.1007/s11912-011-0203-y.
PubMed 22012633
Mujoomdar A, Austin JH, Malhotra R, Powell CA, Pearson GD, Shiau MC, Raftopoulos H. Clinical predictors of metastatic disease to the brain from non-small cell lung carcinoma: primary tumor size, cell type, and lymph node metastases. Radiology. 2007 Mar;242(3):882-8. doi: 10.1148/radiol.2423051707. Epub 2007 Jan 17.
PubMed 17229875
Shin DY, Na II, Kim CH, Park S, Baek H, Yang SH. EGFR mutation and brain metastasis in pulmonary adenocarcinomas. J Thorac Oncol. 2014 Feb;9(2):195-9. doi: 10.1097/JTO.0000000000000069.
PubMed 24419416
Khalifa J, Amini A, Popat S, Gaspar LE, Faivre-Finn C; International Association for the Study of Lung Cancer Advanced Radiation Technology Committee. Brain Metastases from NSCLC: Radiation Therapy in the Era of Targeted Therapies. J Thorac Oncol. 2016 Oct;11(10):1627-43. doi: 10.1016/j.jtho.2016.06.002. Epub 2016 Jun 23.
PubMed 27343440
Yang P, Kulig K, Boland JM, Erickson-Johnson MR, Oliveira AM, Wampfler J, Jatoi A, Deschamps C, Marks R, Fortner C, Stoddard S, Nichols F, Molina J, Aubry MC, Tang H, Yi ES. Worse disease-free survival in never-smokers with ALK+ lung adenocarcinoma. J Thorac Oncol. 2012 Jan;7(1):90-7. doi: 10.1097/JTO.0b013e31823c5c32.
PubMed 22134072
Aoyama H, Shirato H, Tago M, Nakagawa K, Toyoda T, Hatano K, Kenjyo M, Oya N, Hirota S, Shioura H, Kunieda E, Inomata T, Hayakawa K, Katoh N, Kobashi G. Stereotactic radiosurgery plus whole-brain radiation therapy vs stereotactic radiosurgery alone for treatment of brain metastases: a randomized controlled trial. JAMA. 2006 Jun 7;295(21):2483-91. doi: 10.1001/jama.295.21.2483.
PubMed 16757720
Chang EL, Wefel JS, Hess KR, Allen PK, Lang FF, Kornguth DG, Arbuckle RB, Swint JM, Shiu AS, Maor MH, Meyers CA. Neurocognition in patients with brain metastases treated with radiosurgery or radiosurgery plus whole-brain irradiation: a randomised controlled trial. Lancet Oncol. 2009 Nov;10(11):1037-44. doi: 10.1016/S1470-2045(09)70263-3. Epub 2009 Oct 2.
PubMed 19801201
Kocher M, Soffietti R, Abacioglu U, Villa S, Fauchon F, Baumert BG, Fariselli L, Tzuk-Shina T, Kortmann RD, Carrie C, Ben Hassel M, Kouri M, Valeinis E, van den Berge D, Collette S, Collette L, Mueller RP. Adjuvant whole-brain radiotherapy versus observation after radiosurgery or surgical resection of one to three cerebral metastases: results of the EORTC 22952-26001 study. J Clin Oncol. 2011 Jan 10;29(2):134-41. doi: 10.1200/JCO.2010.30.1655. Epub 2010 Nov 1.
PubMed 21041710
Brown PD, Jaeckle K, Ballman KV, Farace E, Cerhan JH, Anderson SK, Carrero XW, Barker FG 2nd, Deming R, Burri SH, Menard C, Chung C, Stieber VW, Pollock BE, Galanis E, Buckner JC, Asher AL. Effect of Radiosurgery Alone vs Radiosurgery With Whole Brain Radiation Therapy on Cognitive Function in Patients With 1 to 3 Brain Metastases: A Randomized Clinical Trial. JAMA. 2016 Jul 26;316(4):401-409. doi: 10.1001/jama.2016.9839.
PubMed 27458945
Steeg PS, Camphausen KA, Smith QR. Brain metastases as preventive and therapeutic targets. Nat Rev Cancer. 2011 May;11(5):352-63. doi: 10.1038/nrc3053. Epub 2011 Apr 7.
PubMed 21472002
Wu YL, Zhou C, Cheng Y, Lu S, Chen GY, Huang C, Huang YS, Yan HH, Ren S, Liu Y, Yang JJ. Erlotinib as second-line treatment in patients with advanced non-small-cell lung cancer and asymptomatic brain metastases: a phase II study (CTONG-0803). Ann Oncol. 2013 Apr;24(4):993-9. doi: 10.1093/annonc/mds529. Epub 2012 Nov 4.
PubMed 23129122
Iuchi T, Shingyoji M, Sakaida T, Hatano K, Nagano O, Itakura M, Kageyama H, Yokoi S, Hasegawa Y, Kawasaki K, Iizasa T. Phase II trial of gefitinib alone without radiation therapy for Japanese patients with brain metastases from EGFR-mutant lung adenocarcinoma. Lung Cancer. 2013 Nov;82(2):282-7. doi: 10.1016/j.lungcan.2013.08.016. Epub 2013 Aug 28.
PubMed 24021541
Fan Y, Huang Z, Fang L, Miao L, Gong L, Yu H, Yang H, Lei T, Mao W. A phase II study of icotinib and whole-brain radiotherapy in Chinese patients with brain metastases from non-small cell lung cancer. Cancer Chemother Pharmacol. 2015 Sep;76(3):517-23. doi: 10.1007/s00280-015-2760-5. Epub 2015 Jul 7.
PubMed 26148750
Schuler M, Wu YL, Hirsh V, O'Byrne K, Yamamoto N, Mok T, Popat S, Sequist LV, Massey D, Zazulina V, Yang JC. First-Line Afatinib versus Chemotherapy in Patients with Non-Small Cell Lung Cancer and Common Epidermal Growth Factor Receptor Gene Mutations and Brain Metastases. J Thorac Oncol. 2016 Mar;11(3):380-90. doi: 10.1016/j.jtho.2015.11.014. Epub 2016 Jan 25.
PubMed 26823294
Soria JC, Tan DSW, Chiari R, Wu YL, Paz-Ares L, Wolf J, Geater SL, Orlov S, Cortinovis D, Yu CJ, Hochmair M, Cortot AB, Tsai CM, Moro-Sibilot D, Campelo RG, McCulloch T, Sen P, Dugan M, Pantano S, Branle F, Massacesi C, de Castro G Jr. First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer (ASCEND-4): a randomised, open-label, phase 3 study. Lancet. 2017 Mar 4;389(10072):917-929. doi: 10.1016/S0140-6736(17)30123-X. Epub 2017 Jan 24.
PubMed 28126333

Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Phase II Trial of Brain Radiotherapy Combined With Targeted Therapy in Patients With Asymptomatic NSCLC Brain Metastasis With Gene Sensitive Mutation
ClinicalTrials.gov ID: NCT04193007
Acronym / sponsor ID: BRATR / Y-Q201802-009
Conditions: Non Small Cell Lung Cancer, Brain Metastases
Keywords: Non Small Cell Lung Cancer, Brain Metastases
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
Collaborators: Nanchang University
Study start: 1 Dec 2019 (estimated)
Primary completion: 30 Dec 2021 (estimated)
Study completion: 1 Jun 2022 (estimated)
First posted: 10 Dec 2019 (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.

Detailed description

Study design

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

Arm	Type	Receives
molecular targeted therapy group	Experimental	Drug: molecular targeted therapiesMolecular targeted therapy(according to the results of gene detection, targeted drugs were selected, such as EGFR mutation using the first generation of EGFR-TKI,ALK or ROS1 mutation using the first generation of ALK inhibitors)
Brain Radiotherapy and molecular targeted therapy group	Experimental	Drug: molecular targeted therapies, Radiation: Brain RadiotherapyBrain Radiotherapy (stereotactic radiotherapy was used for 1-3 intracranial lesions, and simultaneous modulated accelerated radiation therapy for Brain(SMART-Brain )was used for more than 3 intracranial lesions);Molecular targeted therapy(according to the results of gene detection, targeted drugs were selected, such as EGFR mutation using the first generation of EGFR-TKI,ALK or ROS1 mutation using the first generation of ALK inhibitors)

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Histology confirmed that it was non-small cell lung cancer;
EGFR, ALK or ROS1 gene detection showed sensitive gene mutation, and patients were willing to receive targeted therapy;
brain MRI confirmed brain metastasis;
asymptomatic or symptomatic brain metastasis could be controlled by glucocorticoid;
PS score 0-1;

Key exclusion criteria (7 listed)

Small cell lung cancer was confirmed by pathology;
other malignant tumors (unless PFS ≥ 3 years, except non-black skin cancer);
were treated with brain radiotherapy or targeted therapy before;
those with other potentially serious diseases (congestive heart failure, transmural myocardial infarction, admission with severe acute bacterial or fungal infection, COPD or other respiratory diseases that affect treatment, etc.), Taking into account that the study may exacerbate or fail to control the disease;
severe immunosuppressive diseases, such as AIDS;

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
molecular targeted therapiesAlso: Targeted Therapy, Molecular, Therapy, Molecular Targeted, Targeted Molecular Therapiesif EGFR mutation is positive, (gefitinib, ecotinib, erlotinib）or ALK/ROS-1 positive（Crizotinib）	Drug	Brain Radiotherapy and molecular targeted therapy group, molecular targeted therapy group
Brain RadiotherapyAlso: Stereotactic radiotherapy,SRS, simultaneous modulated accelerated radiation therapy for Brain,SMART-BrainSRS was used for 1-3 intracranial lesions, and simultaneous modulated accelerated radiation therapy for Brain(SMART-Brain)was used for more than 3 intracranial lesions	Radiation	Brain Radiotherapy and molecular targeted therapy group

Primary outcome

Intracranial progression-free survival,iPFS-LM
Time frame: Every 6 weeks up to 2 years
Time from BM diagnosis to the first documentation of intracranial lesion progression or death with documented intracranial progression
Objective Response Rate,ORR
Time frame: 1 month after treatment
ORR, proportion of patients with a best overall response of complete response or partial response (CR+PR)

3 secondary outcomes

Progress Free Survival rate,PFS
Time frame: Every 6 weeks up to 2 years
Median Survival Time,MST
Time frame: Every 6 weeks up to 2 years
adverse events
Time frame: Every 6 weeks up to 2 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
Results publication: PubMed 22012633Nayak L, Lee EQ, Wen PY. Epidemiology of brain metastases. Curr Oncol Rep. 2012 Feb;14(1):48-54. doi: 10.1007/s11912-011-0203-y.
Results publication: PubMed 17229875Mujoomdar A, Austin JH, Malhotra R, Powell CA, Pearson GD, Shiau MC, Raftopoulos H. Clinical predictors of metastatic disease to the brain from non-small cell lung carcinoma: primary tumor size, cell type, and lymph node metastases. Radiology. 2007 Mar;242(3):882-8. doi: 10.1148/radiol.2423051707. Epub 2007 Jan 17.
Results publication: PubMed 24419416Shin DY, Na II, Kim CH, Park S, Baek H, Yang SH. EGFR mutation and brain metastasis in pulmonary adenocarcinomas. J Thorac Oncol. 2014 Feb;9(2):195-9. doi: 10.1097/JTO.0000000000000069.
Results publication: PubMed 27343440Khalifa J, Amini A, Popat S, Gaspar LE, Faivre-Finn C; International Association for the Study of Lung Cancer Advanced Radiation Technology Committee. Brain Metastases from NSCLC: Radiation Therapy in the Era of Targeted Therapies. J Thorac Oncol. 2016 Oct;11(10):1627-43. doi: 10.1016/j.jtho.2016.06.002. Epub 2016 Jun 23.
Results publication: PubMed 22134072Yang P, Kulig K, Boland JM, Erickson-Johnson MR, Oliveira AM, Wampfler J, Jatoi A, Deschamps C, Marks R, Fortner C, Stoddard S, Nichols F, Molina J, Aubry MC, Tang H, Yi ES. Worse disease-free survival in never-smokers with ALK+ lung adenocarcinoma. J Thorac Oncol. 2012 Jan;7(1):90-7. doi: 10.1097/JTO.0b013e31823c5c32.
Results publication: PubMed 16757720Aoyama H, Shirato H, Tago M, Nakagawa K, Toyoda T, Hatano K, Kenjyo M, Oya N, Hirota S, Shioura H, Kunieda E, Inomata T, Hayakawa K, Katoh N, Kobashi G. Stereotactic radiosurgery plus whole-brain radiation therapy vs stereotactic radiosurgery alone for treatment of brain metastases: a randomized controlled trial. JAMA. 2006 Jun 7;295(21):2483-91. doi: 10.1001/jama.295.21.2483.
Results publication: PubMed 19801201Chang EL, Wefel JS, Hess KR, Allen PK, Lang FF, Kornguth DG, Arbuckle RB, Swint JM, Shiu AS, Maor MH, Meyers CA. Neurocognition in patients with brain metastases treated with radiosurgery or radiosurgery plus whole-brain irradiation: a randomised controlled trial. Lancet Oncol. 2009 Nov;10(11):1037-44. doi: 10.1016/S1470-2045(09)70263-3. Epub 2009 Oct 2.
Results publication: PubMed 21041710Kocher M, Soffietti R, Abacioglu U, Villa S, Fauchon F, Baumert BG, Fariselli L, Tzuk-Shina T, Kortmann RD, Carrie C, Ben Hassel M, Kouri M, Valeinis E, van den Berge D, Collette S, Collette L, Mueller RP. Adjuvant whole-brain radiotherapy versus observation after radiosurgery or surgical resection of one to three cerebral metastases: results of the EORTC 22952-26001 study. J Clin Oncol. 2011 Jan 10;29(2):134-41. doi: 10.1200/JCO.2010.30.1655. Epub 2010 Nov 1.
Results publication: PubMed 27458945Brown PD, Jaeckle K, Ballman KV, Farace E, Cerhan JH, Anderson SK, Carrero XW, Barker FG 2nd, Deming R, Burri SH, Menard C, Chung C, Stieber VW, Pollock BE, Galanis E, Buckner JC, Asher AL. Effect of Radiosurgery Alone vs Radiosurgery With Whole Brain Radiation Therapy on Cognitive Function in Patients With 1 to 3 Brain Metastases: A Randomized Clinical Trial. JAMA. 2016 Jul 26;316(4):401-409. doi: 10.1001/jama.2016.9839.
Results publication: PubMed 21472002Steeg PS, Camphausen KA, Smith QR. Brain metastases as preventive and therapeutic targets. Nat Rev Cancer. 2011 May;11(5):352-63. doi: 10.1038/nrc3053. Epub 2011 Apr 7.
Results publication: PubMed 23129122Wu YL, Zhou C, Cheng Y, Lu S, Chen GY, Huang C, Huang YS, Yan HH, Ren S, Liu Y, Yang JJ. Erlotinib as second-line treatment in patients with advanced non-small-cell lung cancer and asymptomatic brain metastases: a phase II study (CTONG-0803). Ann Oncol. 2013 Apr;24(4):993-9. doi: 10.1093/annonc/mds529. Epub 2012 Nov 4.
Results publication: PubMed 24021541Iuchi T, Shingyoji M, Sakaida T, Hatano K, Nagano O, Itakura M, Kageyama H, Yokoi S, Hasegawa Y, Kawasaki K, Iizasa T. Phase II trial of gefitinib alone without radiation therapy for Japanese patients with brain metastases from EGFR-mutant lung adenocarcinoma. Lung Cancer. 2013 Nov;82(2):282-7. doi: 10.1016/j.lungcan.2013.08.016. Epub 2013 Aug 28.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Liu Anwen, Phd contact

+8613767120022

awliu666@163.com

Cai Jing, Phd contact

+8615270905381

cjdl879@163.com

Liu Anwen, Phd study director

Second Affiliated Hospital of Nanchang University

1 site 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 10 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Liu Anwen, Phd (+8613767120022, awliu666@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intracranial progression-free survival,iPFS-LM (time frame: Every 6 weeks up to 2 years). The study lists 2 primary outcomes in all. 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 NCT04193007, which also lists 17 linked publications.

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 10 Dec 2019.