Non-Small Cell Lung CancerNILENCT03615443
Noninvasive vs. Invasive Lung Evaluation
An observational study of Non-Small Cell Lung Cancer, run by Guardant Health, Inc..
Trial summary
Tumor derived cell free DNA (cfDNA) is increasingly used in the clinic to obtain genotype information about lung cancer, but its concordance with concurrent tumor-derived sequenced data is not known. The purpose of the trial is to determine the non-inferiority of cfDNA-based vs. 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?
- Guardant360
- How many people
- 306 participants
- Where
- No sites listed yet
- Study dates
- 12 Feb 2016to 23 Nov 2020
- 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: Treatment-naïve metastatic non-squamous non-small cell lung cancer (NSCLC).
Who may be able to join
- Patients with NSCLC, which is: (1) Biopsy-proven (confirmatory biopsy must have been collected within 12 months prior to enrollment), (2) Metastatic (Stage IV, Stage IIIB when curative intent is not an option, or relapsed/recurrent disease after original diagnosis of Stage I-IIIA), (3) Non-squamous histology (mixed squamous and adenocarcinoma is allowed), (4) No prior treatment for advanced stage NSCLC: (a) Resection of or radiation to a single metastatic site is allowed if there are other untreated and measurable sites of metastatic disease at the time of enrollment. (b) Patients who have previously undergone surgical resection or radiation for Stage I-IIIA NSCLC are eligible if primary treatment was completed at least 6 months prior to the development of metastatic disease; for patients who received adjuvant systemic therapy, the last dose of treatment must be given at least 6 weeks prior to enrollment.
- Age ≥ 18 years
- Ability to understand a written informed consent document, and the willingness to sign it.
- Willingness to provide blood sample at the time points of pre-treatment, approximately 2 weeks after initiation of systemic treatment, and end of study).
- Patient has or will have standard-of-care tissue genotyping ordered. If the physician intends to order tissue genotyping, but there is insufficient material for analysis, the patient is still eligible for enrollment.
Who cannot join
- Pregnancy
- Any other concurrent malignancy except for localized, non-melanoma, cutaneous cancer or non-invasive cervical cancer. Any prior cancer other than NSCLC must have occurred more than 2 years prior to study entry with no evidence of currently active disease.
- Prior treatment for metastatic NSCLC including but not limited to: (1) Systemic treatment (targeted therapy, chemotherapy, immunotherapy, biologic therapy, etc.), (2) Resection of a metastatic lesion if the resected metastasis had been the only site of measurable metastatic disease, or resection of more than one metastatic lesion, (3) Radiation of a metastatic lesion or resection bed if given to the only measurable site of metastatic disease, or radiation to more than one metastatic lesion.
About this study
Tumor derived cell free DNA (cfDNA) is increasingly used in the clinic to obtain genotype information about lung cancer, but its concordance with concurrent tumor-derived sequenced data is not known. The purpose of the trial is to determine the non-inferiority of cfDNA-based vs. tumor tissue-based genotyping as it pertains to the detection of National Comprehensive Cancer Network (NCCN)-recommended biomarkers in first line, treatment naive, non-squamous Non-Small Cell Lung Cancer (NSCLC).
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Guardant360
- 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.
Guardant360Diagnostic test
Guardant360 is a comprehensive, non-invasive tumor sequencing test.
| Study group | Role | What they receive |
|---|---|---|
| Treatment-naive metastatic non-squamous NSCLC | Not described Receives: Diagnostic Test: Guardant360 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the non-inferiority of cfDNA-based vs. tumor tissue-based genotyping
The proportion of subjects for whom a genetic alteration is found in at least one of seven genes (EGFR, ALK, ROS1, BRAF, MET, ERBB2, RET) by testing tumor tissue will be compared to the proportion of subjects for whom a genetic alteration is found in at least one of the same genes by testing cfDNA.
Measured: 34 months
Secondary outcomes (8)
Objective Response Rate (ORR)
The proportion of subjects with complete or partial tumor response as determined by the investigator. This will be assessed for the overall population and for the subpopulation of subjects who are identified by either tissue or cfDNA as having actionable EGFR activating mutations, ALK fusions, ROS1 fusions, and BRAF V600E mutations and who are subsequently treated with tyrosine kinase inhibitors.
Measured: 34 months
Turnaround Time for cfDNA vs. Tissue Results
The time (in days) from the date of request for genetic testing to the report date for cfDNA and for tumor tissue.
Measured: 34 months
Time to Treatment Initiation
The number of days from the date of study enrollment until the date that systemic or localized treatment is initiated.
Measured: 34 months
Quantity Not Sufficient Rate of Tissue for Complete NCCN Biomarker Testing
The proportion of subjects deemed to have quantity not sufficient for tumor tissue testing of any of seven genes (EGFR, ALK, ROS1, BRAF, MET, ERBB2, RET) due to any of the following reasons: 1) insufficient tumor specimen for the genotyping tests to be performed, or 2) tumor cellularity below lab-dictated minimal requirements, or 3) no results available within 45 days of enrollment.
Measured: 34 months
Tissue Incomplete Rate of Tissue for NCCN Biomarker Testing
The proportion of subjects with tumor tissue testing results not available for all seven genes (EGFR, ALK, ROS1, BRAF, MET, ERBB2, RET) and with no alterations detected among the genes that were tested.
Measured: 34 months
Tumor Not Detected Rate of cfDNA in Blood
The proportion of subjects for whom cfDNA could not be detected in blood.
Measured: 34 months
Sensitivity, Specificity, and Diagnostic Accuracy of Non-NCCN Biomarkers on the Guardant360 Panel
This objective applies to genes included in the Guardant360 panel other than EGFR, ALK, ROS1, BRAF, MET, ERBB2, RET and to subjects for whom both cfDNA and tumor tissue testing results are available. Diagnostic accuracy will include calculations for sensitivity, specificity, positive predictive value, and negative predictive value comparing tissue to cfDNA results and vice versa.
Measured: 34 months
Rate of Discovery of Genomically Mediated, Acquired Resistance to Targeted Therapies in the Biomarker-Positive Subsets
Among subjects with tumor genetic alterations in EGFR, ALK, ROS1, BRAF, MET, ERBB2, or RET, the proportion with new (compared to baseline) genetic alterations in cfDNA at the time of disease progression following treatment with a therapy targeting the specific genetic alteration.
Measured: 34 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start12 Feb 2016
- Primary completion23 Nov 2020
- Study completion23 Nov 2020
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.
- 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
- Other
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guardant Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615443
- Sponsor's protocol ID
- GH03-001
- Acronym
- NILE
- Status last verified
- Apr 2021
- First submitted
- 13 Jul 2018
- Last updated
- 3 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive vs. Invasive Lung Evaluation
- ClinicalTrials.gov ID
- NCT03615443
- Acronym / sponsor ID
- NILE / GH03-001
- Conditions
- Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Guardant Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Feb 2016 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 3 Aug 2018 (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.
Tumor derived cell free DNA (cfDNA) is increasingly used in the clinic to obtain genotype information about lung cancer, but its concordance with concurrent tumor-derived sequenced data is not known. The purpose of the trial is to determine the non-inferiority of cfDNA-based vs. tumor tissue-based genotyping as it pertains to the detection of National Comprehensive Cancer Network (NCCN)-recommended biomarkers in first line, treatment naive, non-squamous Non-Small Cell Lung Cancer (NSCLC).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment-naive metastatic non-squamous NSCLC | – | Diagnostic Test: Guardant360 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Treatment-naïve metastatic non-squamous non-small cell lung cancer (NSCLC).
Key inclusion criteria (5 listed)
- Patients with NSCLC, which is: (1) Biopsy-proven (confirmatory biopsy must have been collected within 12 months prior to enrollment), (2) Metastatic (Stage IV, Stage IIIB when curative intent is not an option, or relapsed/recurrent disease after original diagnosis of Stage I-IIIA), (3) Non-squamous histology (mixed squamous and adenocarcinoma is allowed), (4) No prior treatment for advanced stage NSCLC: (a) Resection of or radiation to a single metastatic site is allowed if there are other untreated and measurable sites of metastatic disease at the time of enrollment. (b) Patients who have previously undergone surgical resection or radiation for Stage I-IIIA NSCLC are eligible if primary treatment was completed at least 6 months prior to the development of metastatic disease; for patients who received adjuvant systemic therapy, the last dose of treatment must be given at least 6 weeks prior to enrollment.
- Age ≥ 18 years
- Ability to understand a written informed consent document, and the willingness to sign it.
- Willingness to provide blood sample at the time points of pre-treatment, approximately 2 weeks after initiation of systemic treatment, and end of study).
- Patient has or will have standard-of-care tissue genotyping ordered. If the physician intends to order tissue genotyping, but there is insufficient material for analysis, the patient is still eligible for enrollment.
Key exclusion criteria (3 listed)
- Pregnancy
- Any other concurrent malignancy except for localized, non-melanoma, cutaneous cancer or non-invasive cervical cancer. Any prior cancer other than NSCLC must have occurred more than 2 years prior to study entry with no evidence of currently active disease.
- Prior treatment for metastatic NSCLC including but not limited to: (1) Systemic treatment (targeted therapy, chemotherapy, immunotherapy, biologic therapy, etc.), (2) Resection of a metastatic lesion if the resected metastasis had been the only site of measurable metastatic disease, or resection of more than one metastatic lesion, (3) Radiation of a metastatic lesion or resection bed if given to the only measurable site of metastatic disease, or radiation to more than one metastatic lesion.
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 |
|---|---|---|
| Guardant360Guardant360 is a comprehensive, non-invasive tumor sequencing test. | Diagnostic test | Treatment-naive metastatic non-squamous NSCLC |
Primary outcome
Demonstrate the non-inferiority of cfDNA-based vs. tumor tissue-based genotyping
Time frame: 34 months
The proportion of subjects for whom a genetic alteration is found in at least one of seven genes (EGFR, ALK, ROS1, BRAF, MET, ERBB2, RET) by testing tumor tissue will be compared to the proportion of subjects for whom a genetic alteration is found in at least one of the same genes by testing cfDNA.
8 secondary outcomes
Objective Response Rate (ORR)
Time frame: 34 months
Turnaround Time for cfDNA vs. Tissue Results
Time frame: 34 months
Time to Treatment Initiation
Time frame: 34 months
Quantity Not Sufficient Rate of Tissue for Complete NCCN Biomarker Testing
Time frame: 34 months
Tissue Incomplete Rate of Tissue for NCCN Biomarker Testing
Time frame: 34 months
Tumor Not Detected Rate of cfDNA in Blood
Time frame: 34 months
Sensitivity, Specificity, and Diagnostic Accuracy of Non-NCCN Biomarkers on the Guardant360 Panel
Time frame: 34 months
Rate of Discovery of Genomically Mediated, Acquired Resistance to Targeted Therapies in the Biomarker-Positive Subsets
Time frame: 34 months
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 3 May 2021.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by Guardant Health, Inc..
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 5 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 3 May 2021. 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?
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?
Demonstrate the non-inferiority of cfDNA-based vs. tumor tissue-based genotyping (time frame: 34 months). 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 3 May 2021.