NCT04263688

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

February 7, 2020

Last Update Submit

February 10, 2020

Conditions

Non-Small Cell Lung Cancer

Keywords

Multicenter Observational StudyTumor Mutation Burden (TMB)immunotherapyPleural effusion

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    2022

Study Arms (2)

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.

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.

Other: Non-Intervention

Interventions

Non-InterventionOTHER

Non-Intervention

Immunotherapy IneffectiveImmunotherapy effective

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Histologically or cytologically proven diagnosis of ⅢB-Ⅳ NSCLC

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 30082870BACKGROUND

  • 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.

    PMID: 29857892BACKGROUND

  • 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.

    PMID: 30643254BACKGROUND

  • 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.

    PMID: 28420421BACKGROUND

  • 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.

    PMID: 30816954BACKGROUND

  • 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.

    PMID: 29262275BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungPleural Effusion

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPleural Diseases

Central Study Contacts

Chengzhi Zhou

CONTACT

020-83062830doctorzcz@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

February 7, 2020

First Posted

February 11, 2020

Study Start

March 1, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2022

Last Updated

February 12, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share