ClinicalTrials.gg
Status unknownNCT03373955Updated Mar 18, 2021

A Prospective Study of Constructing Immune Repertoire to Monitor the Therapeutic Effect in NSCLC Patients

An observational study in Non-small Cell Lung Cancer, sponsored by Sichuan University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-18.

Sponsored by Sichuan University · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.

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Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 16 studies in Carcinoma, Non-Small-Cell Lung by Sichuan University — 10 open to participants now, 10 under way, none of them phase 3. Carcinoma, Non-Small-Cell Lung · Sichuan University.

Started
2017
the only one that year
Observational
Only one
of the 16
Registered
4th of 16
by date

Among the 16 studies in Carcinoma, Non-Small-Cell Lung by Sichuan University, this one is the only one that started in 2017, is the only observational one, and was the 4th registered.

Carcinoma, Non-Small-Cell Lung

7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.

Browse Carcinoma, Non-Small-Cell Lung studies →

Open to participants now

10 of the 16 studies in Carcinoma, Non-Small-Cell Lung by Sichuan University are open now, in 1 country. Recruiting first, the newest first:

5 more — sign in →

By country, each count listing its studies:

All 10 open studies →

Where they have run

Who these studies take

Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 16 studies in Carcinoma, Non-Small-Cell Lung by Sichuan University, or all of them as a file.
02

Study summary

This study is designed to evaluate the untreated NSCLC patients. After participants have accepted chemotherapy, radiotherapy, and immunotherapy, the investigators used the next generation sequence technology (NGS) to construct immune repertoire to detective variation of patients' immune state and to monitor patients' therapeutic effect. The investigators are aim to explore the novel clone sequence as potential therapy target.

Read the detailed description

Lung cancer was one of the most deadly tumors in the world. The standard of care for patients is platinum-based doublet chemotherapy concurrent with radiotherapy. As for patients with a mutant epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase(ALK), EGFR or ALK tyrosine kinase inhibitors (TKIs) are the standard first-line therapy. Now, the Food and Drug Administration approved Ipilimumab, Nivolumab, and Pembrolizumab as first-line or second-line therapy for NSCLC. However, there was no reports about therapeutic effect for NSCLC patients through detecting herself immune state, immune repertoire could explore patients' immune clonality and diversity using NGS technology.The investigators look forward to illuminate the mechanism of patients antitumor action.

03

Conditions studied

  • Non-small Cell Lung Cancer

Keywords

  • T Cell repertoire
  • lung cancer
  • tumor mutation burden
  • Circulating tumour DNA
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients diagnosed of locally advanced or metastatic non small cell lung cancer progressed without previous treatment.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • verified stage IV non-small cell lung cancer without treated.
  • (ECOG) performance status of 0 or 1
  • Major organs function normally
  • Women at pregnant ages should be under
  • Willing and able to provide

Exclusion criteria

Exclusion Criteria:

  • Pathology is mixed type•
  • Poor vasculature
  • Coagulopathy, or ongoing thrombolytics and/or anticoagulation
  • Blood-borne infectious disease, e.g.
  • History of mandatory custody because of psychosis or other psychological disease inappropriate for treatment deemed by treating physician
  • Other conditions requiring exclusion deemed by physician
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Immunotherapy,chemotherapy,radiotherapy

    Pembrolizumab will be administered via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent.The peripheral blood will be collected at 3 weeks,2 months, 6 months,an average of 1 year

    Drug: pembrolizumab

Interventions

06

What researchers measure

Primary outcomes

  1. T cell repertoire

    peripheral blood was collected at baseline,3 weeks,2 months, 6 months,an average of 1 year

    Time frame: baseline, 2 months, 6 months, 1 year

Secondary outcomes

  1. peripheral blood circulating tumor DNA

    peripheral blood was collected at baseline,3 weeks,2 months, 6 months,an average of 1 year

    Time frame: baseline, 2 months, 6 months, 1 year

07

Study locations

1 of 1 sites recruiting
  • West China Hospital, Sichuan University
    Chengdu, Sichuan 610041, China
    Recruiting
08

References and documents

Publications

  • Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5. PubMed 28055103 ↗
  • Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E, Barlesi F, Kohlhaufl M, Arrieta O, Burgio MA, Fayette J, Lena H, Poddubskaya E, Gerber DE, Gettinger SN, Rudin CM, Rizvi N, Crino L, Blumenschein GR Jr, Antonia SJ, Dorange C, Harbison CT, Graf Finckenstein F, Brahmer JR. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. doi: 10.1056/NEJMoa1507643. Epub 2015 Sep 27. PubMed 26412456 ↗
  • Garon EB, Rizvi NA, Hui R, Leighl N, Balmanoukian AS, Eder JP, Patnaik A, Aggarwal C, Gubens M, Horn L, Carcereny E, Ahn MJ, Felip E, Lee JS, Hellmann MD, Hamid O, Goldman JW, Soria JC, Dolled-Filhart M, Rutledge RZ, Zhang J, Lunceford JK, Rangwala R, Lubiniecki GM, Roach C, Emancipator K, Gandhi L; KEYNOTE-001 Investigators. Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med. 2015 May 21;372(21):2018-28. doi: 10.1056/NEJMoa1501824. Epub 2015 Apr 19. PubMed 25891174 ↗
  • Schumacher TN, Schreiber RD. Neoantigens in cancer immunotherapy. Science. 2015 Apr 3;348(6230):69-74. doi: 10.1126/science.aaa4971. PubMed 25838375 ↗
  • Yarchoan M, Johnson BA 3rd, Lutz ER, Laheru DA, Jaffee EM. Targeting neoantigens to augment antitumour immunity. Nat Rev Cancer. 2017 Apr;17(4):209-222. doi: 10.1038/nrc.2016.154. Epub 2017 Feb 24. Erratum In: Nat Rev Cancer. 2017 Aug 24;17(9):569. doi: 10.1038/nrc.2017.74. PubMed 28233802 ↗
  • Ott PA, Hu Z, Keskin DB, Shukla SA, Sun J, Bozym DJ, Zhang W, Luoma A, Giobbie-Hurder A, Peter L, Chen C, Olive O, Carter TA, Li S, Lieb DJ, Eisenhaure T, Gjini E, Stevens J, Lane WJ, Javeri I, Nellaiappan K, Salazar AM, Daley H, Seaman M, Buchbinder EI, Yoon CH, Harden M, Lennon N, Gabriel S, Rodig SJ, Barouch DH, Aster JC, Getz G, Wucherpfennig K, Neuberg D, Ritz J, Lander ES, Fritsch EF, Hacohen N, Wu CJ. An immunogenic personal neoantigen vaccine for patients with melanoma. Nature. 2017 Jul 13;547(7662):217-221. doi: 10.1038/nature22991. Epub 2017 Jul 5. Erratum In: Nature. 2018 Mar 14;555(7696):402. doi: 10.1038/nature25145. PubMed 28678778 ↗
  • Khodadoust MS, Olsson N, Wagar LE, Haabeth OA, Chen B, Swaminathan K, Rawson K, Liu CL, Steiner D, Lund P, Rao S, Zhang L, Marceau C, Stehr H, Newman AM, Czerwinski DK, Carlton VE, Moorhead M, Faham M, Kohrt HE, Carette J, Green MR, Davis MM, Levy R, Elias JE, Alizadeh AA. Antigen presentation profiling reveals recognition of lymphoma immunoglobulin neoantigens. Nature. 2017 Mar 30;543(7647):723-727. doi: 10.1038/nature21433. Epub 2017 Mar 22. PubMed 28329770 ↗
  • Robbins PF, Kassim SH, Tran TL, Crystal JS, Morgan RA, Feldman SA, Yang JC, Dudley ME, Wunderlich JR, Sherry RM, Kammula US, Hughes MS, Restifo NP, Raffeld M, Lee CC, Li YF, El-Gamil M, Rosenberg SA. A pilot trial using lymphocytes genetically engineered with an NY-ESO-1-reactive T-cell receptor: long-term follow-up and correlates with response. Clin Cancer Res. 2015 Mar 1;21(5):1019-27. doi: 10.1158/1078-0432.CCR-14-2708. Epub 2014 Dec 23. PubMed 25538264 ↗
  • Apetoh L, Ghiringhelli F, Tesniere A, Obeid M, Ortiz C, Criollo A, Mignot G, Maiuri MC, Ullrich E, Saulnier P, Yang H, Amigorena S, Ryffel B, Barrat FJ, Saftig P, Levi F, Lidereau R, Nogues C, Mira JP, Chompret A, Joulin V, Clavel-Chapelon F, Bourhis J, Andre F, Delaloge S, Tursz T, Kroemer G, Zitvogel L. Toll-like receptor 4-dependent contribution of the immune system to anticancer chemotherapy and radiotherapy. Nat Med. 2007 Sep;13(9):1050-9. doi: 10.1038/nm1622. Epub 2007 Aug 19. PubMed 17704786 ↗
  • Herrera FG, Bourhis J, Coukos G. Radiotherapy combination opportunities leveraging immunity for the next oncology practice. CA Cancer J Clin. 2017 Jan;67(1):65-85. doi: 10.3322/caac.21358. Epub 2016 Aug 29. PubMed 27570942 ↗
  • Twyman-Saint Victor C, Rech AJ, Maity A, Rengan R, Pauken KE, Stelekati E, Benci JL, Xu B, Dada H, Odorizzi PM, Herati RS, Mansfield KD, Patsch D, Amaravadi RK, Schuchter LM, Ishwaran H, Mick R, Pryma DA, Xu X, Feldman MD, Gangadhar TC, Hahn SM, Wherry EJ, Vonderheide RH, Minn AJ. Radiation and dual checkpoint blockade activate non-redundant immune mechanisms in cancer. Nature. 2015 Apr 16;520(7547):373-7. doi: 10.1038/nature14292. Epub 2015 Mar 9. PubMed 25754329 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2017 (actual). Primary completion is estimated for Jul 2021, 44 months after the start.

Of 356 non-industry observational studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 126. This study's planned 44 months is below that.

Counting every sponsor, half of 498 studies reached it within 55 months; a quarter within 35 and three quarters within 83.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 23, 2017
First posted
Dec 14, 2017
StartActual
Nov 23, 2017
Primary completionEst.
Jul 31, 2021
CompletionEst.
Dec 31, 2021
Last update
Mar 18, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03373955
Lead sponsor
Sichuan University
Collaborators
Geneplus-Beijing Co. Ltd.
Responsible party
You Lu (Chair of Department of Thoracic Oncology, Sichuan University) — Principal investigator
First posted
Dec 14, 2017
Start date
Nov 23, 2017
Primary completion
Jul 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Mar 18, 2021

Study contacts

You Lu, MD
Contact
radyoulu@hotmali.com
+8602885423571
Ruizhan Tong, MD
Contact
sunnyt.r.zhan@163.com
+8602885423571
You Lu, MD
principal investigator · West China Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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