Non Small Cell Lung CancerNCT04312308
A Study for Identification of Predictive Immune Biomarker for Atezolizumab Therapy in NSCLC Patients
An observational study of Non Small Cell Lung Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
The study aimed to elucidate predictive immune related biomarker to the responsiveness to the PD-L1 blockade and evaluate the dynamics of immune cells in peripheral blood from NSCLC patients during atezolizumab treatment. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Sample collection
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Apr 2020to 26 Jan 2025
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Non-Small Cell Lung Cancer Treated with Atezolizumab
Who may be able to join
- Signed Written Informed Consent
- Subjects must have signed and dated an IRB/IEC-approved written informed consent form in accordance with regulatory and institutional guidelines.
- Target Population
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1
- Subjects with histologically- or cytologically-documented NSCLC who presented with Stage IIIB/Stage IV disease and who have relapsed after treatment for stage IIIB/stage IV disease following chemotherapy, radiation therapy, or surgical resection.
- Subjects must have disease progression or recurrence during or after at least 1 systemic therapy for advanced or metastatic disease.
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- Each subsequent line of therapy must be preceded by disease progression. ii) Subjects who received platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, and developed recurrent (local or metastatic) disease within 6 months of completing therapy are eligible.
- Subjects with recurrent disease > 6 months after completing a platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, who also subsequently progressed during or after a systemic regimen given to treat the recurrence, are eligible.
- Prior chemotherapy or TKI therapy must have been completed at least 1 week before study drug administration. All AEs due to prior chemotherapy or immunotherapy have either returned to baseline or stabilized.
- Prior palliative radiotherapy must have been completed at least 7 days prior to study drug administration.
- Subjects are eligible if CNS metastases are treated or subjects have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 14 days prior to enrollment. In addition, subjects must either be off corticosteroids or on a stable dose or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) g) Screening laboratory values must meet the following criteria prior to commencement of treatment: i) WBCs ≥ 2000/µL ii) Neutrophils ≥1500/µL iii) Platelets ≥ 100 X10³/µL iv) Hemoglobin ≥ 9.0 g/dL v) Serum creatinine of ≤ 1.5 X ULN or creatinine clearance (CrCl) > 40 mL/minute (using Cockcroft/Gault formula)
- (1). Female CrCl= [(140- age in years) X weight in kg X 0.85) ÷ (72 X serum creatinine in mg/ dL)] (2). Male CrCl= [(140- age in years) X weight in kg X 1.00) ÷ (72 X serum creatinine in mg/ dL)] vi) AST and ALT ≤ 3 X ULN (In the case of patients with liver metastasis, AST (GOT) and ALT (GPT) ≤ 5.0 times the upper limit of normal range) vii) Total bilirubin ≤ 1.5 X ULN (except subjects with Gilbert Syndrome, who must have total bilirubin < 3.0 mg/dL) h) Subjects with Type I diabetes mellitus, residual hypothyroidism due to an autoimmune condition requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Subjects with available PD-L1 immunohistochemistry (IHC) result could be enrolled regardless of the results of PD-L1 IHC.
- Subject re-enrollment: This study permits the re-enrollment of a subject who has discontinued the study as a pre-treatment failure (ie, subject has not been treated). If re- enrolled, the subject must be re-consented.
- 3. Age and Reproductive Status
- Men and women aged ≥ 18 years old
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug
- Women must not be breastfeeding
- WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with atezolizumab plus 5 half-lives of atezolizumab (5 x half-life = 135 days) plus 30 days (duration of ovulatory cycle) for a total of 165 days or 24 weeks post-treatment completion.
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with atezolizumab plus 5 half-lives of the study drug (135 days) plus 90 days (duration of sperm turnover) for a total of 32 weeks post-treatment completion.
- Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, they must still undergo pregnancy testing as described in this section.
- Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of < 1% when used consistently and correctly.
- At a minimum, subjects must agree to the use of 2 methods of contraception, with 1 method being highly effective and the other method being either highly effective or less effective as listed below:
- HIGHLY EFFECTIVE METHODS OF CONTRACEPTION
- Male condoms with spermicide
- Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectables, implants, and intrauterine devices (IUDs) such as Mirena® by WOCBP subject or male subject's WOCBP partner. Female partners of male subjects participating in the study may use hormone-based contraceptives as one of the acceptable methods of contraception since they will not be receiving study drug.
- Non-hormonal IUDs, such as ParaGard®
- Tubal ligation
- Vasectomy
- Complete abstinence NOTE: Complete abstinence is defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs.
- Subjects who choose complete abstinence are not required to use a second method of contraception, but female subjects must continue to have pregnancy tests. Acceptable alternative methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence.
- LESS EFFECTIVE METHODS OF CONTRACEPTION
- Diaphragm with spermicide
- Cervical cap with spermicide
- Vaginal sponge
- Male condom without spermicide
- Progestin only pills by WOCBP subject or male subject's WOCBP partner
- Female condom
- NOTE: A male and female condom must not be used together
Who cannot join
- Target Disease Exceptions i) Subjects with ECOG PS ≥ 2 ii) Subjects with untreated CNS metastases are excluded. Subjects are eligible if CNS metastases are treated or subjects have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. In addition, subjects must either be off corticosteroids or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).
- Subjects with carcinomatous meningitis are excluded iv) Subjects with < 6 weeks life expectancy b) Medical History and Concurrent Diseases i) Subjects with known active, known, or suspected autoimmune disease which the investigator considers significant ii) Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first dose of study drug administration. Inhaled or topical steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.
- Subjects who received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CT137 or anti-CTLA-4 antibody including ipilimumab or any other antibody or drug specifically targeting T cell costimulation or checkpoint pathways iv) Subjects with interstitial lung disease. v) Other active malignancy requiring concurrent intervention vi) Subjects with previous malignancies (except non-melanoma skin cancers and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 1 year prior to study entry AND no additional therapy is required during the study period vii) Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the subject to receive protocol therapy viii) All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to Grade 1 (NCI CTCAE version 5) or baseline before administration of study drug ix) Subjects must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before the first dose of study treatment x) Known alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
The study aimed to elucidate predictive immune related biomarker to the responsiveness to the PD-L1 blockade and evaluate the dynamics of immune cells in peripheral blood from NSCLC patients during atezolizumab treatment.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Sample collection
- Keywords
- Immune biomarker
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample collectionOther
- .Analysis of immune marker using FACS before treatment and Cycle1, Cycle2, Cycle3 and the time of disease progression.
- .Multiplexed biomarker analysis of tumor and immune cells in tumor microenvironment (TME) at pre-treatment and progression (Pre-treatment biopsy is mandatory but biopsy is optional for disease progression)
- microbiome Pretreatment stool sample will be collected. (Stool sample is optional)
4.Genetic analysis For RNAseq or exome seq, biopsied tissue at baseline or progression are optional.
4.Single cell RNA sequencing (scRNA-seq) scRNA-seq will be performed by collecting selectively tissues from pre-treatment tumor biopsies and at relapse/acquired resistance tumor biopsies. Screening and treatment biopsies are optional.
| Study group | Role | What they receive |
|---|---|---|
| Non-Small Cell Lung Cancer Treated with Atezolizumab | Patients with Non-Small Cell Lung Cancer Treated with Atezolizumab Receives: Other: Sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore early biomarker to predict response and overall survival after Atezolizumab therapy
Analysis of immune marker using FACS
Measured: up to 1year
To explore early biomarker to predict response and overall survival after Atezolizumab therapy
Multiplexed biomarker analysis of tumor and immune cells in tumor microenvironment (TME) (Pre-treatment biopsy is mandatory but biopsy is optional for disease progression)
Measured: up to 1year
To explore early biomarker to predict response and overall survival after Atezolizumab therapy
microbiome
Measured: up to 1year
To explore early biomarker to predict response and overall survival after Atezolizumab therapy
Genetic analysis
Measured: up to 1year
To explore early biomarker to predict response and overall survival after Atezolizumab therapy
Single cell RNA sequencing (scRNA-seq)
Measured: up to 1year
Secondary outcomes (4)
ORR(Objective response rate)
The manner and interval of efficacy assessment for tumor scan will depends on the investigator's decision.
Measured: Atezolizumab treatment will be given every 3 weeks up to progression or 1 year. The manner and interval of efficacy assessment for tumor scan will depends on the investigator's decision.
PFS(Progression free survival)
The manner and interval of efficacy assessment for tumor scan will depends on the investigator's decision.
Measured: Atezolizumab treatment will be given every 3 weeks up to progression or 1 year. The manner and interval of efficacy assessment for tumor scan will depends on the investigator's decision.
OS(Overall survival)
Overall survival will be followed continuously while subjects are on the study drug and every 6 months after discontinuation or progression for up to 5 years following the start of therapy either by direct contact (office visits) or via telephone contact, until death, withdrawal of study consent, or lost to follow-up. Overall survival is defined as the time between the start of treatment and the date of death due to any cause.
Measured: Overall survival will be followed continuously while subjects are on the study drug and every 6 months after discontinuation or progression for up to 5 years
Safety
Number of participants with adverse events and abnormal laboratory values as assessed by NCI-CTCAE version 5
Measured: local laboratory assessments should be done with prior to each atezolizumab dose Atezolizumab treatment will be given every 3 weeks up to progression or 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start8 Apr 2020
- Primary completion26 Jan 2025
- Study completion26 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Gon Kim, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312308
- Sponsor's protocol ID
- 4-2019-0948
- Status last verified
- Feb 2025
- First submitted
- 28 Feb 2020
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study for Identification of Predictive Immune Biomarker for Atezolizumab Therapy in NSCLC Patients
- ClinicalTrials.gov ID
- NCT04312308
- Acronym / sponsor ID
- 4-2019-0948
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Immune biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- 26 Jan 2025 (actual)
- Study completion
- 26 Jan 2025 (actual)
- First posted
- 18 Mar 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.
The study aimed to elucidate predictive immune related biomarker to the responsiveness to the PD-L1 blockade and evaluate the dynamics of immune cells in peripheral blood from NSCLC patients during atezolizumab treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-Small Cell Lung Cancer Treated with Atezolizumab | – | Other: Sample collectionPatients with Non-Small Cell Lung Cancer Treated with Atezolizumab |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-Small Cell Lung Cancer Treated with Atezolizumab
Key inclusion criteria (39 listed)
- Signed Written Informed Consent
- Target Population
- (1). Female CrCl= [(140- age in years) X weight in kg X 0.85) ÷ (72 X serum creatinine in mg/ dL)] (2). Male CrCl= [(140- age in years) X weight in kg X 1.00) ÷ (72 X serum creatinine in mg/ dL)] vi) AST and ALT ≤ 3 X ULN (In the case of patients with liver metastasis, AST (GOT) and ALT (GPT) ≤ 5.0 times the upper limit of normal range) vii) Total bilirubin ≤ 1.5 X ULN (except subjects with Gilbert Syndrome, who must have total bilirubin < 3.0 mg/dL) h) Subjects with Type I diabetes mellitus, residual hypothyroidism due to an autoimmune condition requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Subjects with available PD-L1 immunohistochemistry (IHC) result could be enrolled regardless of the results of PD-L1 IHC.
- Subject re-enrollment: This study permits the re-enrollment of a subject who has discontinued the study as a pre-treatment failure (ie, subject has not been treated). If re- enrolled, the subject must be re-consented.
Key exclusion criteria (3 listed)
- Target Disease Exceptions i) Subjects with ECOG PS ≥ 2 ii) Subjects with untreated CNS metastases are excluded. Subjects are eligible if CNS metastases are treated or subjects have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. In addition, subjects must either be off corticosteroids or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).
- Subjects with carcinomatous meningitis are excluded iv) Subjects with < 6 weeks life expectancy b) Medical History and Concurrent Diseases i) Subjects with known active, known, or suspected autoimmune disease which the investigator considers significant ii) Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first dose of study drug administration. Inhaled or topical steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.
- Subjects who received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CT137 or anti-CTLA-4 antibody including ipilimumab or any other antibody or drug specifically targeting T cell costimulation or checkpoint pathways iv) Subjects with interstitial lung disease. v) Other active malignancy requiring concurrent intervention vi) Subjects with previous malignancies (except non-melanoma skin cancers and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 1 year prior to study entry AND no additional therapy is required during the study period vii) Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the subject to receive protocol therapy viii) All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to Grade 1 (NCI CTCAE version 5) or baseline before administration of study drug ix) Subjects must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before the first dose of study treatment x) Known alcohol or drug abuse
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 |
|---|---|---|
| Sample collection1. .Analysis of immune marker using FACS before treatment and Cycle1, Cycle2, Cycle3 and the time of disease progression. 2. .Multiplexed biomarker analysis of tumor and immune cells in tumor microenvironment (TME) at pre-treatment and progression (Pre-treatment biopsy is mandatory but biopsy is optional for disease progression) 3. microbiome Pretreatment stool sample will be collected. (Stool sample is optional) 4.Genetic analysis For RNAseq or exome seq, biopsied tissue at baseline or progression are optional. 4.Single cell RNA sequencing (scRNA-seq) scRNA-seq will be performed by collecting selectively tissues from pre-treatment tumor biopsies and at relapse/acquired resistance tumor biopsies. Screening and treatment biopsies are optional. | Other | Non-Small Cell Lung Cancer Treated with Atezolizumab |
Primary outcome
To explore early biomarker to predict response and overall survival after Atezolizumab therapy
Time frame: up to 1year
Analysis of immune marker using FACS
To explore early biomarker to predict response and overall survival after Atezolizumab therapy
Time frame: up to 1year
Multiplexed biomarker analysis of tumor and immune cells in tumor microenvironment (TME) (Pre-treatment biopsy is mandatory but biopsy is optional for disease progression)
To explore early biomarker to predict response and overall survival after Atezolizumab therapy
Time frame: up to 1year
microbiome
To explore early biomarker to predict response and overall survival after Atezolizumab therapy
Time frame: up to 1year
Genetic analysis
To explore early biomarker to predict response and overall survival after Atezolizumab therapy
Time frame: up to 1year
Single cell RNA sequencing (scRNA-seq)
4 secondary outcomes
ORR(Objective response rate)
Time frame: Atezolizumab treatment will be given every 3 weeks up to progression or 1 year. The manner and interval of efficacy assessment for tumor scan will depends on the investigator's decision.
PFS(Progression free survival)
Time frame: Atezolizumab treatment will be given every 3 weeks up to progression or 1 year. The manner and interval of efficacy assessment for tumor scan will depends on the investigator's decision.
OS(Overall survival)
Time frame: Overall survival will be followed continuously while subjects are on the study drug and every 6 months after discontinuation or progression for up to 5 years
Safety
Time frame: local laboratory assessments should be done with prior to each atezolizumab dose Atezolizumab treatment will be given every 3 weeks up to progression or 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Yonsei University at 1 site in South Korea.
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 39 inclusion and 3 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: finished, as of the sponsor's last update on 6 Feb 2026. 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 South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To explore early biomarker to predict response and overall survival after Atezolizumab therapy (time frame: up to 1year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2026.