Metastatic Non-Small Cell Lung CarcinomaNCT03892096
Development of a Cell Free DNA Assay as a Biomarker for Predicting Early Non-response to Therapy in Metastatic Cancer
An observational study of Metastatic Non-Small Cell Lung Carcinoma and Metastatic Colorectal Cancer, run by Cadex Genomics at 12 sites in 2 countries.
Trial summary
Accrue samples for the further development and clinical validation of a blood-based cell-free DNA (cfDNA) quantitative real-time polymerase chain reaction (qPCR) assay as a potential biomarker for early non-response to therapy in stage IV non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and breast cancer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Non-Small Cell Lung Carcinoma, Metastatic Colorectal Cancer, Metastatic Breast Cancer
- What is being tested?
- Blood-based cell-free cfDNA qPCR assay
- How many people
- 130 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 1 Mar 2019to 6 Feb 2024
- 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: A total of 750 subjects with Lung Cancer, CRC or BC will be enrolled consecutively into each cancer group. It is expected that each group will enroll 250 subjects each. As each group meets its enrollment goals, that group will close to further enrollment.
Who may be able to join
- Age ≥ 18 years.
- Documented stage IV NSCLC, SCLC, BC or CRC (can be new diagnosis, persistent or recurrent disease):
- BC patients who meet the following criteria:
- ER+/HER2- and has failed hormone therapy within the last two years, or ER+/HER2+ or, ER-/HER+ or, HER2-/ER-/PR- (TNBC), and Has ≥ 1 measurable non- bone lesion as measured per RECIST or, If bone only disease, has two or more measurable (> 1 cm by RECIST) predominantly lytic bone lesions
- Planned initiation of new systemic first- or second-line treatment or subsequent therapies with chemotherapy, immunotherapy, targeted therapy or combination thereof. Or continuation of the current line of therapy after RECIST/iRECIST evaluation which coincides with end of the cycle of therapy and prior to initiation of the next cycle of therapy.
- Imaging to determine RECIST and/or iRECIST criteria:
Show all 10Show fewer
- If baseline blood draw is planned prior to first cycle of a line (1st, 2nd, 3rd etc) of therapy, measurable disease with CT or MRI or PET/CT monitoring should be completed within 4 weeks prior to baseline blood draw.
- If baseline test is performed at the completion of a cycle of therapy, CT or MRI or PET/CT monitoring should be completed to coincide with end of cycle of therapy and prior to baseline blood draw.
- Planned CT or MRI or PET/CT monitoring for treatment response completed within 8-12 weeks of start of treatment.
- Willing and able to donate up to 30mL of blood at each blood draw. Willing and able to provide informed consent.
Who cannot join
- Diagnosis of a secondary malignancy that is not in complete remission. Imaging to determine RECIST and/or iRECIST criteria is not planned or available.
- CT or MRI or PET/CT monitoring for treatment response is not planned within 8-12 weeks.
- Presence of active autoimmune disease which is under active treatment. DVT, PE, sepsis, or has recovered from any other serious illness within the prior 2 weeks of the baseline blood draw. (Note: Patients who have recovered from similar conditions more than 2 weeks prior to the baseline blood draw would be eligible for the study) If initiating a new line of therapy, patient has received any doses of the new block of therapy before the first designated blood draw.
- If continuing current line of therapy after CT, MRI or PET/CT monitoring, patient has received subsequent cycle of therapy before the first designated blood draw.
- Performance status ECOG ≥3. Evidence of acute renal failure as determined by current clinical guidelines. NSCLC, SCLC or CRC patients beyond 9 months of the initiation of therapy, on 1st line immunotherapy alone, or combination immunotherapy and chemotherapy regimens. (Note: patients on subsequent lines of therapy (2nd,3rd line etc.) would be eligible at any time point including prior to the 9 months vs those patients on 1st line therapy)..
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
Waverly Hematology Oncology
Cary, North Carolina, 27518
IACT Health
Columbus, Georgia, 31904
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Greenville Health System - Prisma Health
Greenville, South Carolina, 29605
Advent Health
Hendersonville, North Carolina, 28732
CARTI Cancer Center
Little Rock, Arkansas, 72205
University Medical Center
New Orleans, Louisiana, 70112
Southeast Louisiana Veterans Health Care System
New Orleans, Louisiana, 70119
Nebraska Cancer Center
Omaha, Nebraska, 68130
National Translational Research Group LLC
Port Jefferson Station, New York, 11776
Sutter Health - Palo Alto Medical Foundation
Sunnyvale, California, 94086
About this study
Accrue samples for the further development and clinical validation of a blood-based cell-free DNA (cfDNA) quantitative real-time polymerase chain reaction (qPCR) assay as a potential biomarker for early non-response to therapy in stage IV non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and breast cancer (BC).
Read the detailed description
Most anticancer drugs are effective only in subgroups of patients, and our current understanding of tumor biology does not allow us to predict accurately which patient will benefit from a specific therapeutic regimen. The definitive proof of the effectiveness of a therapy is improvement in clinical symptoms and survival. Imaging is generally used to assess therapeutic effects earlier and more objectively. Current response assessment is based primarily on changes in tumor size as measured by CT or other anatomic imaging modalities.
Cadex Genomics has developed an analytically validated cell-free DNA (cfDNA) quantitative real-time polymerase chain reaction (qPCR) assay that utilizes standard qPCR platforms for processing, this test can reliably obtain results from small blood volumes and possesses exceptionally high analytical sensitivity of circulating cfDNA.
The purpose of this study is to accrue samples for the further development and clinical validation of a blood-based cell-free cfDNA qPCR assay as a potential biomarker for early non-response to therapy in stage IV non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and breast cancer (BC).
- Conditions
- Metastatic Non-Small Cell Lung Carcinoma, Metastatic Colorectal Cancer, Metastatic Breast Cancer
- Being tested
- Blood-based cell-free cfDNA qPCR assay
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood-based cell-free cfDNA qPCR assayDiagnostic test
Up to 30mL of blood via venipuncture
| Study group | Role | What they receive |
|---|---|---|
| Metastatic Lung Cancer, Colorectal Cancer or Breast Cancer | A total of 750 subjects with lung cancer, CRC and breast cancer will be consecutively enrolled. It is expected that 250 subjects will be lung cancer patients, 250 mCRC patients and 250 breast cancer patients. Receives: Diagnostic Test: Blood-based cell-free cfDNA qPCR assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA Integrity Index as a predictor of progressive disease in a cohort of metastatic patients (250 Lung Cancer (NSCLC, SCLC), 250 CRC and 250 BC patients as compared to standard RECIST/iRECIST criteria.
A total of 750 subjects (250 stage IV Lung Cancer, IV 250 CRC and IV BC) will be enrolled consecutively into the study. Blood specimens will be collected at the initiation of therapy and 12 to 16 days after the initiation of therapy. A course of therapy is defined as chemotherapy, immunotherapy or oral therapy. Standard baseline RECIST or iRECIST will be recorded before the initiation therapy and again at 9-12 weeks. For those patients who are receiving single agent regimen consisting of immunotherapy alone there will be an additional blood draw prior to administration of the second course of therapy. The Integrity Index will be evaluated for predicting early non-response to therapy as compared to standard RECIST/iRECIST results.
Measured: Six months to accrue patient for initial development
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Mar 2019
- Primary completion15 Nov 2023
- Study completion6 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Non-Small Cell Lung CarcinomaStudies 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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cadex Genomics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christer Svedman, M.D. Ph.D., Study director, Cadex Genomics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892096
- Sponsor's protocol ID
- CADEX-0001
- Status last verified
- Feb 2023
- First submitted
- 21 Mar 2019
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Cell Free DNA Assay as a Biomarker for Predicting Early Non-response to Therapy in Metastatic Cancer
- ClinicalTrials.gov ID
- NCT03892096
- Acronym / sponsor ID
- CADEX-0001
- Conditions
- Metastatic Non-Small Cell Lung Carcinoma, Metastatic Colorectal Cancer, Metastatic Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Cadex GenomicsIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 27 Mar 2019 (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.
Accrue samples for the further development and clinical validation of a blood-based cell-free DNA (cfDNA) quantitative real-time polymerase chain reaction (qPCR) assay as a potential biomarker for early non-response to therapy in stage IV non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and breast cancer (BC).
Detailed description
Most anticancer drugs are effective only in subgroups of patients, and our current understanding of tumor biology does not allow us to predict accurately which patient will benefit from a specific therapeutic regimen. The definitive proof of the effectiveness of a therapy is improvement in clinical symptoms and survival. Imaging is generally used to assess therapeutic effects earlier and more objectively. Current response assessment is based primarily on changes in tumor size as measured by CT or other anatomic imaging modalities.
Cadex Genomics has developed an analytically validated cell-free DNA (cfDNA) quantitative real-time polymerase chain reaction (qPCR) assay that utilizes standard qPCR platforms for processing, this test can reliably obtain results from small blood volumes and possesses exceptionally high analytical sensitivity of circulating cfDNA.
The purpose of this study is to accrue samples for the further development and clinical validation of a blood-based cell-free cfDNA qPCR assay as a potential biomarker for early non-response to therapy in stage IV non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and breast cancer (BC).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic Lung Cancer, Colorectal Cancer or Breast Cancer | – | Diagnostic Test: Blood-based cell-free cfDNA qPCR assayA total of 750 subjects with lung cancer, CRC and breast cancer will be consecutively enrolled. It is expected that 250 subjects will be lung cancer patients, 250 mCRC patients and 250 breast cancer patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 750 subjects with Lung Cancer, CRC or BC will be enrolled consecutively into each cancer group. It is expected that each group will enroll 250 subjects each. As each group meets its enrollment goals, that group will close to further enrollment.
Key inclusion criteria (10 listed)
- Age ≥ 18 years.
- Documented stage IV NSCLC, SCLC, BC or CRC (can be new diagnosis, persistent or recurrent disease):
- ER+/HER2- and has failed hormone therapy within the last two years, or ER+/HER2+ or, ER-/HER+ or, HER2-/ER-/PR- (TNBC), and Has ≥ 1 measurable non- bone lesion as measured per RECIST or, If bone only disease, has two or more measurable (> 1 cm by RECIST) predominantly lytic bone lesions
- Planned initiation of new systemic first- or second-line treatment or subsequent therapies with chemotherapy, immunotherapy, targeted therapy or combination thereof. Or continuation of the current line of therapy after RECIST/iRECIST evaluation which coincides with end of the cycle of therapy and prior to initiation of the next cycle of therapy.
- If baseline blood draw is planned prior to first cycle of a line (1st, 2nd, 3rd etc) of therapy, measurable disease with CT or MRI or PET/CT monitoring should be completed within 4 weeks prior to baseline blood draw.
Key exclusion criteria (5 listed)
- Diagnosis of a secondary malignancy that is not in complete remission. Imaging to determine RECIST and/or iRECIST criteria is not planned or available.
- CT or MRI or PET/CT monitoring for treatment response is not planned within 8-12 weeks.
- Presence of active autoimmune disease which is under active treatment. DVT, PE, sepsis, or has recovered from any other serious illness within the prior 2 weeks of the baseline blood draw. (Note: Patients who have recovered from similar conditions more than 2 weeks prior to the baseline blood draw would be eligible for the study) If initiating a new line of therapy, patient has received any doses of the new block of therapy before the first designated blood draw.
- If continuing current line of therapy after CT, MRI or PET/CT monitoring, patient has received subsequent cycle of therapy before the first designated blood draw.
- Performance status ECOG ≥3. Evidence of acute renal failure as determined by current clinical guidelines. NSCLC, SCLC or CRC patients beyond 9 months of the initiation of therapy, on 1st line immunotherapy alone, or combination immunotherapy and chemotherapy regimens. (Note: patients on subsequent lines of therapy (2nd,3rd line etc.) would be eligible at any time point including prior to the 9 months vs those patients on 1st line therapy)..
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 |
|---|---|---|
| Blood-based cell-free cfDNA qPCR assayUp to 30mL of blood via venipuncture | Diagnostic test | Metastatic Lung Cancer, Colorectal Cancer or Breast Cancer |
Primary outcome
DNA Integrity Index as a predictor of progressive disease in a cohort of metastatic patients (250 Lung Cancer (NSCLC, SCLC), 250 CRC and 250 BC patients as compared to standard RECIST/iRECIST criteria.
Time frame: Six months to accrue patient for initial development
A total of 750 subjects (250 stage IV Lung Cancer, IV 250 CRC and IV BC) will be enrolled consecutively into the study. Blood specimens will be collected at the initiation of therapy and 12 to 16 days after the initiation of therapy. A course of therapy is defined as chemotherapy, immunotherapy or oral therapy. Standard baseline RECIST or iRECIST will be recorded before the initiation therapy and again at 9-12 weeks. For those patients who are receiving single agent regimen consisting of immunotherapy alone there will be an additional blood draw prior to administration of the second course of therapy. The Integrity Index will be evaluated for predicting early non-response to therapy as compared to standard RECIST/iRECIST results.
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 7 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Metastatic Non-Small Cell Lung Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 3
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer
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.
Christer Svedman, M.D. Ph.D. study director
Cadex Genomics
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Non-Small Cell Lung Carcinoma and Metastatic Colorectal Cancer, run by Cadex Genomics at 12 sites in 2 countries.
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 10 inclusion and 5 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 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada. 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?
DNA Integrity Index as a predictor of progressive disease in a cohort of metastatic patients (250 Lung Cancer (NSCLC, SCLC), 250 CRC and 250 BC patients as compared to standard RECIST/iRECIST criteria. (time frame: Six months to accrue patient for initial development). 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 7 Feb 2024.