Multicenter Observational Study of Advanced Non-small Cell Lung Cancer With Malignant Pleural Effusion

An observational study of Non-Small Cell Lung Cancer, run by Guangzhou Institute of Respiratory Disease.

Unknown status

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 The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

Multicenter observational study for correlation between tumor mutation burden and immunotherapy efficacy of advanced non-small cell lung cancer with malignant pleural effusion Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small Cell Lung Cancer
What is being tested?: Non-Intervention
How many people: 300 participants
Where: No sites listed yet
Study dates: 1 Mar 2020to 1 Mar 2022
Phase: Observational
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Histologically or cytologically proven diagnosis of ⅢB-Ⅳ NSCLC

Who may be able to join

male or female,18 years ≤ age ≤80 years;
Pathologically confirmed stage ⅢB-Ⅳ NSCLC, which is not suitable for surgical resection;
No systematic anti-tumor treatment;
Pleural effusion ≥50ml,tissue samples can be obtained;
The driver gene was negative, and immunotherapy was proposed;
According to RECIST 1.1, at least one tumor lesion that can be measured or evaluated;
Signed and dated informed consent

Who cannot join

No pathological diagnosis or the diagnosis is not clear;
Severe pneumonia or tuberculosis;
Tumor tissues cannot be obtained;
Combine with other tumor type or other subtypes of lung cancer;
Poor compliance, unable to complete follow-up;
The investigator judges the situation that may affect the clinical search process and results

Trial locations and contacts

No sites are listed yet.

Chengzhi Zhou contact

020-83062830

doctorzcz@163.com

About this study

Official title: Multicenter Observational Study for Correlation Between Tumor Mutation Burden and Immunotherapy Efficacy of Advanced Non-small Cell Lung Cancer With Malignant Pleural Effusion

Multicenter observational study for correlation between tumor mutation burden and immunotherapy efficacy of advanced non-small cell lung cancer with malignant pleural effusion

Read the detailed description

Method of Research:

ⅢB-Ⅳ NSCLC patients, tumor mutation burden (TMB) was tested by the 448 gene panel with pleural effusion and tissue sample, to observed mutation characteristics;Tissue and pleural effusion cell precipitation:TMB (Next generation sequencing, 448 gene panel;Average sequencing depth: above 5000×)
The date of blood routine examination(neutrophils to lymphocytes ratio (NLR)) and serological tumor maker of NSCLC were collected before treatment;the The results of Programmed death ligand 1 (PDL1) expression level were collected also;
Collected Imaging(CT)and pathological data before treatment;
Immunotherapy was applied for 8 weeks to evaluate the efficacy;
The tumor mutation burden of pleural effusion was tested again for the patients of hyper-progression after immunotherapy, the mutation characteristics and changes were observed, the molecular mutation change before and after treatment were evaluated, and the correlation with immunotherapy was analyzed.Hyper-progression (HPD) were defined as tumor growth rate excess of 50% compared to baseline CT scans prior to treatment initiation.The patient underwent imaging examination (chest CT or pet-ct) at 2 months (8 weeks) after 3 full doses of immunotherapy drugs.
The date of blood routine examination(neutrophils to lymphocytes ratio (NLR)) and serological tumor maker of NSCLC were collected after treatment;
Imaging, CT and pathological data of patients after treatment were collected

Conditions: Non-Small Cell Lung Cancer
Being tested: Non-Intervention
Keywords: Multicenter Observational Study, Tumor Mutation Burden (TMB), immunotherapy, Pleural effusion
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Pleural Effusion

What participants receive

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

Non-InterventionOther
Non-Intervention

Study groups in NCT04263688
Study group	Role	What they receive
Immunotherapy effective		Immunotherapy was applied for 8 weeks to evaluate the efficacy，The efficacy of immunotherapy was evaluated by imaging, and was evaluated according to RECIST 1.1. Receives: Other: Non-Intervention
Immunotherapy Ineffective		Immunotherapy was applied for 8 weeks to evaluate the efficacy，The efficacy of immunotherapy was evaluated by imaging, and was evaluated according to RECIST 1.1. Receives: Other: Non-Intervention

What is being measured

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

Objective response rate (ORR) of NSCLC patients with malignant pleural effusion who were received immunotherapy
The relationship between tumor mutation burden and objective response rate in NSCLC patients
Measured: 2021
Progression-free survival (PFS) of NSCLC patients with malignant pleural effusion who were received immunotherapy
The relationship between tumor mutation burden and progression-free survival in NSCLC patients
Measured: 2021
Overall survival (OS) of NSCLC patients with malignant pleural effusion who were received immunotherapy
The relationship between tumor mutation burden and overall survival in NSCLC patients
Measured: 2022

Timeline

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

1 Mar 20201 Mar 2022

First posted11 Feb 2020
Study start1 Mar 2020 (estimated)
Primary completion1 Mar 2021 (estimated)
Study completion1 Mar 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04263688
Sponsor's protocol ID: LC-IMMA
Status last verified: Feb 2020
First submitted: 7 Feb 2020
Last updated: 12 Feb 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Gandara DR, Paul SM, Kowanetz M, Schleifman E, Zou W, Li Y, Rittmeyer A, Fehrenbacher L, Otto G, Malboeuf C, Lieber DS, Lipson D, Silterra J, Amler L, Riehl T, Cummings CA, Hegde PS, Sandler A, Ballinger M, Fabrizio D, Mok T, Shames DS. Blood-based tumor mutational burden as a predictor of clinical benefit in non-small-cell lung cancer patients treated with atezolizumab. Nat Med. 2018 Sep;24(9):1441-1448. doi: 10.1038/s41591-018-0134-3. Epub 2018 Aug 6.
PubMed 30082870
Qin BD, Jiao XD, Zang YS. Tumor mutation burden to tumor burden ratio and prediction of clinical benefit of anti-PD-1/PD-L1 immunotherapy. Med Hypotheses. 2018 Jul;116:111-113. doi: 10.1016/j.mehy.2018.05.005. Epub 2018 May 16.
PubMed 29857892
Samstein RM, Lee CH, Shoushtari AN, Hellmann MD, Shen R, Janjigian YY, Barron DA, Zehir A, Jordan EJ, Omuro A, Kaley TJ, Kendall SM, Motzer RJ, Hakimi AA, Voss MH, Russo P, Rosenberg J, Iyer G, Bochner BH, Bajorin DF, Al-Ahmadie HA, Chaft JE, Rudin CM, Riely GJ, Baxi S, Ho AL, Wong RJ, Pfister DG, Wolchok JD, Barker CA, Gutin PH, Brennan CW, Tabar V, Mellinghoff IK, DeAngelis LM, Ariyan CE, Lee N, Tap WD, Gounder MM, D'Angelo SP, Saltz L, Stadler ZK, Scher HI, Baselga J, Razavi P, Klebanoff CA, Yaeger R, Segal NH, Ku GY, DeMatteo RP, Ladanyi M, Rizvi NA, Berger MF, Riaz N, Solit DB, Chan TA, Morris LGT. Tumor mutational load predicts survival after immunotherapy across multiple cancer types. Nat Genet. 2019 Feb;51(2):202-206. doi: 10.1038/s41588-018-0312-8. Epub 2019 Jan 14.
PubMed 30643254
Chalmers ZR, Connelly CF, Fabrizio D, Gay L, Ali SM, Ennis R, Schrock A, Campbell B, Shlien A, Chmielecki J, Huang F, He Y, Sun J, Tabori U, Kennedy M, Lieber DS, Roels S, White J, Otto GA, Ross JS, Garraway L, Miller VA, Stephens PJ, Frampton GM. Analysis of 100,000 human cancer genomes reveals the landscape of tumor mutational burden. Genome Med. 2017 Apr 19;9(1):34. doi: 10.1186/s13073-017-0424-2.
PubMed 28420421
Wang Z, Duan J, Cai S, Han M, Dong H, Zhao J, Zhu B, Wang S, Zhuo M, Sun J, Wang Q, Bai H, Han J, Tian Y, Lu J, Xu T, Zhao X, Wang G, Cao X, Li F, Wang D, Chen Y, Bai Y, Zhao J, Zhao Z, Zhang Y, Xiong L, He J, Gao S, Wang J. Assessment of Blood Tumor Mutational Burden as a Potential Biomarker for Immunotherapy in Patients With Non-Small Cell Lung Cancer With Use of a Next-Generation Sequencing Cancer Gene Panel. JAMA Oncol. 2019 May 1;5(5):696-702. doi: 10.1001/jamaoncol.2018.7098.
PubMed 30816954
Yarchoan M, Hopkins A, Jaffee EM. Tumor Mutational Burden and Response Rate to PD-1 Inhibition. N Engl J Med. 2017 Dec 21;377(25):2500-2501. doi: 10.1056/NEJMc1713444. No abstract available.
PubMed 29262275

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter Observational Study for Correlation Between Tumor Mutation Burden and Immunotherapy Efficacy of Advanced Non-small Cell Lung Cancer With Malignant Pleural Effusion
ClinicalTrials.gov ID: NCT04263688
Acronym / sponsor ID: LC-IMMA
Conditions: Non-Small Cell Lung Cancer
Keywords: Multicenter Observational Study, Tumor Mutation Burden (TMB), immunotherapy, Pleural effusion
Study type: Observational
Recruitment status: Unknown status
Enrolment: 300 participants (estimated)
Lead sponsor: Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
Study start: 1 Mar 2020 (estimated)
Primary completion: 1 Mar 2021 (estimated)
Study completion: 1 Mar 2022 (estimated)
First posted: 11 Feb 2020 (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.

Multicenter observational study for correlation between tumor mutation burden and immunotherapy efficacy of advanced non-small cell lung cancer with malignant pleural effusion

Detailed description

Method of Research:

ⅢB-Ⅳ NSCLC patients, tumor mutation burden (TMB) was tested by the 448 gene panel with pleural effusion and tissue sample, to observed mutation characteristics;Tissue and pleural effusion cell precipitation:TMB (Next generation sequencing, 448 gene panel;Average sequencing depth: above 5000×)
The date of blood routine examination(neutrophils to lymphocytes ratio (NLR)) and serological tumor maker of NSCLC were collected before treatment;the The results of Programmed death ligand 1 (PDL1) expression level were collected also;
Collected Imaging(CT)and pathological data before treatment;
Immunotherapy was applied for 8 weeks to evaluate the efficacy;
The tumor mutation burden of pleural effusion was tested again for the patients of hyper-progression after immunotherapy, the mutation characteristics and changes were observed, the molecular mutation change before and after treatment were evaluated, and the correlation with immunotherapy was analyzed.Hyper-progression (HPD) were defined as tumor growth rate excess of 50% compared to baseline CT scans prior to treatment initiation.The patient underwent imaging examination (chest CT or pet-ct) at 2 months (8 weeks) after 3 full doses of immunotherapy drugs.
The date of blood routine examination(neutrophils to lymphocytes ratio (NLR)) and serological tumor maker of NSCLC were collected after treatment;
Imaging, CT and pathological data of patients after treatment were collected

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Immunotherapy effective	–	Other: Non-InterventionImmunotherapy was applied for 8 weeks to evaluate the efficacy，The efficacy of immunotherapy was evaluated by imaging, and was evaluated according to RECIST 1.1.
Immunotherapy Ineffective	–	Other: Non-InterventionImmunotherapy was applied for 8 weeks to evaluate the efficacy，The efficacy of immunotherapy was evaluated by imaging, and was evaluated according to RECIST 1.1.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Histologically or cytologically proven diagnosis of ⅢB-Ⅳ NSCLC

Key inclusion criteria (7 listed)

male or female,18 years ≤ age ≤80 years;
Pathologically confirmed stage ⅢB-Ⅳ NSCLC, which is not suitable for surgical resection;
No systematic anti-tumor treatment;
Pleural effusion ≥50ml,tissue samples can be obtained;
The driver gene was negative, and immunotherapy was proposed;

Key exclusion criteria (6 listed)

No pathological diagnosis or the diagnosis is not clear;
Severe pneumonia or tuberculosis;
Tumor tissues cannot be obtained;
Combine with other tumor type or other subtypes of lung cancer;
Poor compliance, unable to complete follow-up;

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
Non-InterventionNon-Intervention	Other	Immunotherapy Ineffective, Immunotherapy effective

Primary outcome

Objective response rate (ORR) of NSCLC patients with malignant pleural effusion who were received immunotherapy
Time frame: 2021
The relationship between tumor mutation burden and objective response rate in NSCLC patients
Progression-free survival (PFS) of NSCLC patients with malignant pleural effusion who were received immunotherapy
Time frame: 2021
The relationship between tumor mutation burden and progression-free survival in NSCLC patients
Overall survival (OS) of NSCLC patients with malignant pleural effusion who were received immunotherapy
Time frame: 2022
The relationship between tumor mutation burden and overall survival in NSCLC patients

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
Background: PubMed 30082870Gandara DR, Paul SM, Kowanetz M, Schleifman E, Zou W, Li Y, Rittmeyer A, Fehrenbacher L, Otto G, Malboeuf C, Lieber DS, Lipson D, Silterra J, Amler L, Riehl T, Cummings CA, Hegde PS, Sandler A, Ballinger M, Fabrizio D, Mok T, Shames DS. Blood-based tumor mutational burden as a predictor of clinical benefit in non-small-cell lung cancer patients treated with atezolizumab. Nat Med. 2018 Sep;24(9):1441-1448. doi: 10.1038/s41591-018-0134-3. Epub 2018 Aug 6.
Background: PubMed 29857892Qin BD, Jiao XD, Zang YS. Tumor mutation burden to tumor burden ratio and prediction of clinical benefit of anti-PD-1/PD-L1 immunotherapy. Med Hypotheses. 2018 Jul;116:111-113. doi: 10.1016/j.mehy.2018.05.005. Epub 2018 May 16.
Background: PubMed 30643254Samstein RM, Lee CH, Shoushtari AN, Hellmann MD, Shen R, Janjigian YY, Barron DA, Zehir A, Jordan EJ, Omuro A, Kaley TJ, Kendall SM, Motzer RJ, Hakimi AA, Voss MH, Russo P, Rosenberg J, Iyer G, Bochner BH, Bajorin DF, Al-Ahmadie HA, Chaft JE, Rudin CM, Riely GJ, Baxi S, Ho AL, Wong RJ, Pfister DG, Wolchok JD, Barker CA, Gutin PH, Brennan CW, Tabar V, Mellinghoff IK, DeAngelis LM, Ariyan CE, Lee N, Tap WD, Gounder MM, D'Angelo SP, Saltz L, Stadler ZK, Scher HI, Baselga J, Razavi P, Klebanoff CA, Yaeger R, Segal NH, Ku GY, DeMatteo RP, Ladanyi M, Rizvi NA, Berger MF, Riaz N, Solit DB, Chan TA, Morris LGT. Tumor mutational load predicts survival after immunotherapy across multiple cancer types. Nat Genet. 2019 Feb;51(2):202-206. doi: 10.1038/s41588-018-0312-8. Epub 2019 Jan 14.
Background: PubMed 28420421Chalmers ZR, Connelly CF, Fabrizio D, Gay L, Ali SM, Ennis R, Schrock A, Campbell B, Shlien A, Chmielecki J, Huang F, He Y, Sun J, Tabori U, Kennedy M, Lieber DS, Roels S, White J, Otto GA, Ross JS, Garraway L, Miller VA, Stephens PJ, Frampton GM. Analysis of 100,000 human cancer genomes reveals the landscape of tumor mutational burden. Genome Med. 2017 Apr 19;9(1):34. doi: 10.1186/s13073-017-0424-2.
Background: PubMed 30816954Wang Z, Duan J, Cai S, Han M, Dong H, Zhao J, Zhu B, Wang S, Zhuo M, Sun J, Wang Q, Bai H, Han J, Tian Y, Lu J, Xu T, Zhao X, Wang G, Cao X, Li F, Wang D, Chen Y, Bai Y, Zhao J, Zhao Z, Zhang Y, Xiong L, He J, Gao S, Wang J. Assessment of Blood Tumor Mutational Burden as a Potential Biomarker for Immunotherapy in Patients With Non-Small Cell Lung Cancer With Use of a Next-Generation Sequencing Cancer Gene Panel. JAMA Oncol. 2019 May 1;5(5):696-702. doi: 10.1001/jamaoncol.2018.7098.
Background: PubMed 29262275Yarchoan M, Hopkins A, Jaffee EM. Tumor Mutational Burden and Response Rate to PD-1 Inhibition. N Engl J Med. 2017 Dec 21;377(25):2500-2501. doi: 10.1056/NEJMc1713444. No abstract available.
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.

Chengzhi Zhou contact

020-83062830

doctorzcz@163.com

Questions about this trial

What is this clinical trial studying?

An observational study of Non-Small Cell Lung Cancer, run by Guangzhou Institute of Respiratory Disease.

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 7 inclusion and 6 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 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

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.

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 Chengzhi Zhou (020-83062830, doctorzcz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) of NSCLC patients with malignant pleural effusion who were received immunotherapy (time frame: 2021). The study lists 3 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 NCT04263688, which also lists 6 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 12 Feb 2020.