DxB-062-NSCLC: Collection of fresh blood from treatment naive or progressing Stage IV m1b NSCLC cancer patients.
Investigation of Blood Samples from Stage IV Non-Small Cell Lung Cancer Patients
V
Vijay Khatri
Primary Investigator
Enrolling By Invitation
100 years or below
All
Phase
N/A
1 Location
Brief description of study
The purpose of this study is to collect fresh blood from treatment naive or progressing Stage IV M1b Non-Small Cell Lung cancer (NSCLC) patients for research and development purposes.
If the patient is a potential subject the provider will discuss with patient and provide an informed consent for more information.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
Collection of blood samples from adults and children, with consideration to the age, weight, and health of the subjects, along with the collection procedure, the amount of blood to be collected and the frequency of collection. Amount drawn will not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection will not occur more frequently than 2 times per week.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
Conditions:Non-small cell lung cancer, NSCLC
Age:
100 years or below
Gender: All
DxB-062 Inclusion:
Standard Inclusion Criteria:
• Subjects 18 years of age or older.
• Subjects who have provided prior written informed consent to participate may be included in this Study
• Diagnosed with stage IV M1b or stage IV M1c NSCLC cancer by a licensed physician
Specific Inclusion Requirements for subjects collected under the AJCC 7th edition staging guidelines:
• Cohort 1: Primary treatment naïve NSCLC patients (prior to surgery, chemotherapy or any other treatment)
• Cohort 2: Recurrent NSCLC patients:
o one year without chemotherapy
o 6 months without radiation
o Patients are not on any treatment at the time of the blood draw
o Example: If a patient was diagnosed with primary stage I-III NSCLC previously, was treated for it and was in remission (one year without chemo or 6 months without radiation); then got diagnosed with a metastatic stage IV M1b NSCLC or stage IV M1c. Such patient can be enrolled prior to administration of the treatment for the metastatic stage of the disease.
• Cohort 3: Primary or Recurrent NSCLC patients progressed to stage IV M1b or M1c while on current treatment (chemotherapy). Enroll no more than 16 patients in this cohort.
o Blood to be collected prior to the start of the new treatment
o Blood to be collected at any time after the end of the current treatment as long as the patient has not yet started a new therapy
Per AJCC 8th Edition:
• Stage IV M1b NSCLC patients:
o The primary lesion is >7 cm
• Stage IV M1c NSCLC patients:
o radiographic evidence of disseminated disease involving multiple organs.
Specific Inclusion Requirements for subjects collected under the AJCC 8th edition staging guidelines:
• Cohort 1: Primary treatment naïve NSCLC patients (prior to surgery, chemotherapy or any other treatment)
• Cohort 2: Recurrent NSCLC patients:
o one year without chemotherapy
o 6 months without radiation
o Patients are not on any treatment at the time of the blood draw
o Example: If a patient was diagnosed with primary stage I-III NSCLC previously, was treated for it and was in remission (one year without chemo or 6 months without radiation); then got diagnosed with a metastatic stage IV M1c NSCLC. Such patient can be enrolled prior to administration of the treatment for the metastatic stage of the disease.
• Cohort 3: Primary or Recurrent NSCLC patients progressed to stage IV M1c while on current treatment (chemotherapy). Enroll no more than 16 patients in this cohort.
o Blood to be collected prior to the start of the new treatment
o Blood to be collected at any time after the end of the current treatment as long as the patient has not yet started a new therapy
DxB-093 Inclusion:
• Primary PD1/PDL1 treatment naïve NSCLC patients
• Other primary treatments are accepted : surgery, chemotherapy or any other non IO treatment
• Subject is to begin a PD1/PDL1 treatment, baseline collection MUST be done prior to PD1/PDL1 treatment initiation
• Subjects 18 years of age or older.
• Subjects who have provided prior written informed consent to participate may be included in this Study
• Subject has agreed to participate in the two timepoint research collection
• Diagnosed with any stage NSCLC cancer by a licensed physician
DxB-118 Inclusion:
• Male subjects, ≥ 18 years of age
• Subject must have histologically confirmed diagnosis of metastatic castrate resistant prostate cancer (mCRPC)
• Subjects 18 years of age or older.
• Subjects who have provided prior written informed consent to participate may be included in this Study
• Diagnosed with mCRPC by a licensed physician
• Pathologically confirmed
DxB-120 Inclusion:
Standard Inclusion Criteria:
• Subjects 18 years of age or older.
• Subjects who have provided prior written informed consent to participate may be included in this Study
• Diagnosed with stage IV cancer by a licensed physician
Specific Inclusion Criteria:
• Subject must be diagnosed with Stage IV Disease in these Cancer types:
o NSCLC, CRC, Prostate, Ovarian, Breast, GI (Non-CRC), Hepato-Pancreatobiliary, Urinary, Endocrine, Skin (Melanoma, Sarcoma)
• Subjects MUST be
o COHORT 1: Primary Treatment Naïve; collected prior to surgery, chemo, or any other treatment
OR
o COHORT 2: Recurrent Patients who are treatment naïve for the metastatic stage of disease
Cohort 2 for Prostate cancer patients :
-patients progressed from M0 to M1 and are now metastatic
-must be castrate resistant
-Can be on hormone therapy but must be naïve to other treatments for metastatic stage (M1) of disease
DxB-149
Standard Inclusion Criteria:
• Subjects 18 years of age or older.
• Subjects who have provided prior written informed consent to participate may be included in this Study
• Diagnosed with Metastatic Breast cancer (stage IV) by a licensed physician
Specific Inclusion Criteria:
Subject must be diagnosed with Metastatic Breast Cancer, with active (newly diagnosed) OR progressing disease
ER+; 20 subjects to enroll, includes:
ER+/PR-/HER2-
ER+/PR+/HER2-
ER-/PR+/HER2-
HER2+; 20 subjects to enroll, includes:
Any ER/PR status combination/HER2+
o Triple Negative Breast Cancer (TNBC) includes:
ER-/PR-/HER2-
• Subjects MUST be (in order of preference)
o Primary Treatment Naïve; collected prior to surgery, chemo, or any other treatment
OR
o Recurrent Patients who are treatment naïve for the metastatic stage of disease
OR
o Patients currently receiving treatment with evidence of disease progression
DxB-172
Standard Inclusion Criteria:
• Subjects 18 years of age or older.
• Subjects who have provided prior written informed consent to participate may be included in this Study
• Diagnosed clinically or pathologically with Stage III or Stage IV NSCLC by a licensed physician
Specific Inclusion Criteria:
• Subject must be diagnosed with NSCLC, Stage III or Stage IV
o Primary or Recurrent
o NSCLC Adenocarcinoma preferred
However, if a different histology is confirmed, then the sample will be acceptable
• Subjects MUST be (in order of preference)
o Primary Treatment Naïve; collected prior to surgery, chemo, or any other treatment OR
o Patients currently receiving treatment with evidence of disease progression/Non responsive to treatment
Patients must be between lines of treatment at the time of the blood draw. Preferably with at least a washout period of 2 weeks
• Flexible if this becomes prohibitive to collections.
DxB-175
Standard Inclusion Criteria:
• Subjects 18 years of age or older.
• Subjects who have provided prior written informed consent to participate may be included in this Study
• Diagnosed by a licensed physician
Specific Inclusion Criteria:
• Subject must be diagnosed with one of these Cancer types:
o Colorectal Cancer (4 subjects)
o Non-Small Cell Lung Cancer (4 subjects)
o Breast Cancer (4 subjects)
o Ovarian Cancer (4 subjects)
o Prostate Cancer (4 subjects)
• Primary and/or recurrent diagnosis acceptable
• Any Stage is acceptable
• Subjects can be Treatment Naïve, Previously Treated, OR Currently receiving Treatment
o There is no inclusion/exclusion treatment criteria; for example: treatment types, length of treatment cycles, etc.
o Subjects receiving treatment with stable/non-progressing disease are acceptable
DxB-177
Specific Inclusion Criteria:
• Subject must be diagnosed with Metastatic Stage IV Cancer:
o Non-Small Cell Lung Cancer
o Colorectal Cancer
o Prostate Cancer
• Subjects can be treatment naïve or recurrent with treatment history (Cont)
• If Subjects have treatment history, subject MUST be:
o Recurrent Patients who are treatment naïve for the metastatic Stage IV stage of disease
OR
o Patients currently receiving treatment with evidence of disease progression, samples must be collected PRIOR to the initiation of new line of treatment
Wash out period of 1-week for non-oral treatments OTHER than Radiation (no washout required for radiation therapy)
• Non-oral treatments include: surgery, chemotherapy, immunotherapy, other IV treatments
NO wash out period needed for oral treatments; including oral chemotherapy, immunotherapy, hormonal therapy, etc
Standard Inclusion Criteria:
• Subjects 18 years of age or older.
• Subjects who have provided prior written informed consent to participate may be included in this Study
• Diagnosed with Metastatic Stage IV NSCLC, CRC or Prostate Cancer by a licensed physician
DxB-178
Specific Inclusion Requirements:
• Any stage Primary Treatment naïve NSCLC patients OR Recurrent Treatment Naïve NSCLC patients
o Primary Treatment Naïve: newly diagnosed, prior to receiving ANY treatment OR
o Recurrent Treatment Naïve: patient has NOT received any treatment for at least 2 years
• If patient is undergoing surgery for SUSPECTED NSCLC, this subject will be accepted into the study
Standard Inclusion Criteria:
• Subjects 18 years of age or older.
• Subjects who have provided prior written informed consent to participate may be included in this Study
• Diagnosed with any stage NSCLC cancer by a licensed physician
DxB-184
Specific Inclusion Requirements:
• Subjects Diagnosed with Stage III or Stage IV NSCLC
• Disease can be primary or recurrent
• Subjects MUST be immunotherapy treatment naïve, with plans to begin an IO treatment
o Other primary treatments are accepted: surgery, radiation, chemotherapy or any other non-IO treatment
• Subject’s treatment plan should include immunotherapy treatment initiation
Standard Inclusion Criteria:
• Subjects 18 years of age or older.
• Subjects who have provided prior written informed consent to participate may be included in this Study
• Subject has agreed to participate in the specimen collection and follow up data captures
• Diagnosed with any stage NSCLC cancer by a licensed physician
DxB-233
Specific Inclusion
• Diagnosed with Stage III or IV Cancer
o Any cancer type is acceptable
o No gender or race restrictions
o Primary or Recurrent cancers acceptable
o Prior history of cancer is acceptable, IF NOT WITHIN 5 years
• Subjects must be Treatment Naïve or Previously Treated
o Subjects not on any treatment / treatment naïve at time of collection are PREFFERED
o Pre-resection subjects are preferred
Post-resection subjects who have not started chemo or radiation are acceptable
Surgically excised subjects are acceptable, if confirmed staging and treatment status
o Subjects receiving treatment with evidence of disease progression are acceptable; HOWEVER samples must be collected PRIOR to the initiation of new line of treatment.
Wash out period of 1-week for non-oral treatments. Non-oral treatments include: surgery, chemotherapy, immunotherapy, other IV treatments
No wash out period needed for oral treatments; including oral chemotherapy, immunotherapy, hormonal therapy, etc.
No wash out period needed for radiation therapy or injectables (such as Lupron or Casodex
Standard Inclusion
• Subjects 18 years of age or older.
• Subjects who have provided prior written informed consent to participate may be included in this Study
• Diagnosed with Stage III or IV Cancer by a licensed physician
DxB-240
Specific Inclusion
• Diagnosed with Stage III or IV Cancer
o Subjects newly diagnosed or recently diagnosed are PREFFERED
o Primary or Recurrent cancers acceptable
o No gender or race restrictions
o Prior history of cancer is acceptable, IF NOT WITHIN 5 years
• Any cancer type is acceptable; At least one (1) subject for each of the following cancer types:
o Colorectal
o Breast
o Ovarian
o Lung
o Prostate
• Subjects not on any treatment (Treatment Naïve) or Previously Treated are PREFFERED
o Subjects receiving treatment with evidence of disease progression acceptable; HOWEVER, samples must be collected within one month of the start of treatment
o Pre-resection subjects are preferred
Post-resection subjects who have not started chemo or radiation are acceptable
Surgically excised subjects are acceptable, if confirmed staging and treatment status
Standard Inclusion
• Subjects 18 years of age or older.
• Subjects who have provided prior written informed consent to participate may be included in this Study
• Diagnosed with Stage III or IV Cancer by a licensed physician
List exclusion criteria (any criteria which would exclude otherwise acceptable subjects).
DxB-062 Exclusion:
• Younger than 18 years of age
• History of Blood Borne Diseases including HIV, HCV, HBV, and syphilis:
o History of HIV, HBV, HCV and syphilis in the subject’s chart
o Subject verbally confirmed that he/she is HIV, HBV, HCV and syphilis positive.
• Patients who are pregnant, lactating, or generally not healthy enough for blood donation should be excluded.
• Subjects who have not provided prior written informed consent to participate may not be included in this Study.
DxB-093 Exclusion:
• Younger than 18 years of age
• History of Blood Borne Diseases including HIV, HCV, HBV, and syphilis:
o History of HIV, HBV, HCV and syphilis in the subject’s chart
o Subject verbally confirmed that he/she is HIV, HBV, HCV and syphilis positive.
• Patients who are pregnant, lactating, or generally not healthy enough for blood donation should be excluded.
• Subjects who have not provided prior written informed consent to participate may not be included in this Study.
DxB-118 Exclusion:
• Females
• Subjects younger than 18 years of age
• Male Subjects without histologic confirmation of mCRPC
• History of Blood Borne Diseases including HIV, HCV, HBV, and syphilis:
o History of HIV, HBV, HCV and syphilis in the subject’s chart
o Subject verbally confirmed that he/she is HIV, HBV, HCV and syphilis positive.
• Patients who are generally not healthy enough for blood donation should be excluded.
• Subjects who have not provided prior written informed consent to participate may not be included in this Study.
DxB-120 Exclusion:
• Subjects diagnosed with stage of disease other than Stage IV
• Subjects who have received treatment for their primary disease
• Subjects who have received treatment for their recurrent disease
• Younger than 18 years of age
• History of Blood Borne Diseases including HIV, HCV, HBV, and syphilis:
o History of HIV, HBV, HCV and syphilis in the subject’s chart
o Subject verbally confirmed that he/she is HIV, HBV, HCV and syphilis positive.
• Patients who are pregnant, lactating, or generally not healthy enough for blood donation should be excluded.
• Subjects who have not provided prior written informed consent to participate may not be included in this Study.
DxB-149 Exclusion
• Subjects diagnosed with stage of disease other than Stage IV
• Subjects with stable disease
o Subject not progressing on current treatment
o Subjects who are receiving maintenance therapy
• Subjects who are in remission must be excluded
• Younger than 18 years of age
• History of Blood Borne Diseases including HIV, HCV, HBV, and syphilis:
o History of HIV, HBV, HCV and syphilis in the subject’s chart
o Subject verbally confirmed that he/she is HIV, HBV, HCV and syphilis positive.
• Patients who are pregnant, lactating, or generally not healthy enough for blood donation should be excluded.
• Subjects who have not provided prior written informed consent to participate may not be included in this Study.
DxB-172
• Subjects diagnosed with stage of disease other than Stage III or Stage IV
• Subjects with stable disease
o Subject not progressing on current treatment
o Subjects who are receiving maintenance therapy
• Subjects who are in remission must be excluded
• Younger than 18 years of age
• History of Blood Borne Diseases including HIV, HCV, HBV, and syphilis:
o History of HIV, HBV, HCV and syphilis in the subject’s chart
o Subject verbally confirmed that he/she is HIV, HBV, HCV and syphilis positive.
• Patients who are pregnant, lactating, or generally not healthy enough for blood donation should be excluded.
• Subjects who have not provided prior written informed consent to participate may not be included in this Study.
DxB-175
Specific Exclusion Criteria:
• Subjects diagnosed with disease other than what is listed in inclusion
Standard Exclusion Criteria:
• Younger than 18 years of age
• History of Blood Borne Diseases including HIV, HCV, HBV, and syphilis:
o History of HIV, HBV, HCV and syphilis in the subject’s chart
o Subject verbally confirmed that he/she is HIV, HBV, HCV and syphilis positive.
• Patients who are pregnant, lactating, or generally not healthy enough for blood donation should be excluded.
• Subjects who have not provided prior written informed consent to participate may not be included in this Study.
DxB-177
Specific Exclusion Criteria:
• Subjects diagnosed with stage of disease other than Stage IV
o Subjects with mets to the Lymph Nodes (stages II – III) will NOT be accepted
• Subjects with stable disease
o Subject not progressing on current treatment
o Subjects who are receiving maintenance therapy
• Subjects who are in remission must be excluded
Standard Exclusion Criteria:
• Younger than 18 years of age
• History of Blood Borne Diseases including HIV, HCV, HBV, and syphilis:
o History of HIV, HBV, HCV and syphilis in the subject’s chart
o Subject verbally confirmed that he/she is HIV, HBV, HCV and syphilis positive.
• Patients who are pregnant, lactating, or generally not healthy enough for blood donation should be excluded.
• Subjects who have not provided prior written informed consent to participate may not be included in this Study.
DxB-178
Specific Exclusion Criteria:
• Patients currently receiving treatment
• Patients in remission
• Recurrent NSCLC patients who are less than 2 years since receiving treatment
Standard Exclusion Criteria:
• Younger than 18 years of age
• History of Blood Borne Diseases including HIV, HCV, HBV, and syphilis:
o History of HIV, HBV, HCV and syphilis in the subject’s chart
o Subject verbally confirmed that he/she is HIV, HBV, HCV and syphilis positive.
• Patients who are pregnant, lactating, or generally not healthy enough for blood donation should be excluded.
• Subjects who have not provided prior written informed consent to participate may not be included in this Study.
DxB-184
Specific Exclusion Requirements:
• Subjects Diagnosed with Stage I or Stage II NSCLC
• Subjects who are NOT Immunotherapy treatment naïve
o Current or a history of immunotherapy
• Subjects who are NOT to begin immunotherapy treatment
Standard Exclusion Criteria:
• Younger than 18 years of age
• History of Blood Borne Diseases including HIV, HCV, HBV, and syphilis:
o History of HIV, HBV, HCV and syphilis in the subject’s chart
o Subject verbally confirmed that he/she is HIV, HBV, HCV and syphilis positive.
• Patients who are pregnant, lactating, or generally not healthy enough for blood donation should be excluded.
• Subjects who have not provided prior written informed consent to participate may not be included in this Study.
DxB-233
Specific Exclusion
• Subjects NOT diagnosed with Stage III or IV Cancer
• Subjects diagnosed with hematologic malignancies
• Subjects diagnosed with concurrent cancer
Standard Exclusion Criteria
• Subjects younger than 18 years of age.
• History of Blood Borne Diseases including HIV, HCV, HBV, and syphilis:
o History of HIV, HBV, HCV and syphilis in the subject’s chart
o Subject verbally confirmed that he/she is HIV, HBV, HCV and syphilis positive.
• Pregnant, lactating, or subjects who are not healthy enough for blood donation.
• Subjects who have not provided prior written informed consent to participate.
DxB-240
Specific Exclusion Criteria:
• Subjects NOT diagnosed with Stage III or IV Cancer
• Subjects diagnosed with hematologic malignancies
• Subjects diagnosed with concurrent cancer
• Subjects who are in remission
• Subjects with partial responses should be excluded
Standard Exclusion Criteria:
• Subjects younger than 18 years of age.
• History of Blood Borne Diseases including HIV, HCV, HBV, and syphilis:
o History of HIV, HBV, HCV and syphilis in the subject’s chart
o Subject verbally confirmed that he/she is HIV, HBV, HCV and syphilis positive.
• Pregnant, lactating, or subjects who are not healthy enough for blood donation.
• Subjects who have not provided prior written informed consent to participate.
Updated on
03 Sep 2025.
Study ID: ARN-1012, 1706198733
This study investigates the collection of fresh blood from patients with Stage IV Non-Small Cell Lung Cancer (NSCLC). NSCLC is a type of lung cancer that is characterized by the uncontrolled growth of cells in the lung tissue. Stage IV indicates that the cancer has spread beyond the lungs to other parts of the body. The study involves patients who are either newly diagnosed and have not yet received treatment or those whose cancer has progressed despite treatment.
Participants will have their blood drawn up to twice a week, with the total amount not exceeding 50 ml or 3 ml per kg over an eight-week period. The blood collection is done with careful consideration of the participant's age, weight, and health status. The samples are used for research and development purposes to better understand the disease and potential treatments.
Who can participate: Adults 18 years and older with Stage IV NSCLC who have provided prior written consent can participate. Eligible participants include those who are treatment naïve or have progressed despite treatment.
Study details: Participants will provide blood samples for research. Blood will be collected before starting investigational treatments. A placebo is not involved in this study.
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If you need help finding a study or have any questions, please contact us at inhealth@iu.edu
Interested in the study?
This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.