Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy
NCT ID: NCT05715229
Last Updated: 2026-01-21
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE2
Total Enrollment
108 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-09-29
Study Completion Date
2027-04-28
Brief Summary
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This clinical trial plans to assess to what extent the on-treatment circulating tumor DNA (ctDNA) can predict the subset of patients with NSCLC who will respond to immunotherapy treatment only and which patients will need both immunotherapy and chemotherapy modalities for their treatment regimen.
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Detailed Description
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Subjects will be randomized 2:1 and patients in both arms will begin treatment with nivolumab 360 mg intravenously every 3 weeks and ipilimumab 1 mg/kg intravenously every 6 weeks. At five weeks of treatment, subjects will have ctDNA response evaluation with Guardant360 Response assay. At the next cycle of treatment (+/- 2 days), patients in the larger arm will receive treatment based on the Guardant360 Response assay results, as described below. Subjects will undergo ctDNA evaluation with Guardant360 Response assay 6- week post-randomization and at the time of progression. Response to therapy will be assessed by interval imaging with CT scan of the chest/abdomen/pelvis (and MRI brain if applicable) with response evaluated by irRECIST criteria every 12 weeks until disease progression.
Conditions
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Carcinoma, Non-Small-Cell Lung
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Subjects will be randomized 2:1 and patients in both arms will begin treatment with nivolumab 360 mg intravenously every 3 weeks and ipilimumab 1 mg/kg intravenously every 6 weeks. At five weeks of treatment, subjects will have ctDNA response evaluation with Guardant360 Response assay. At the next cycle of treatment (+/- 2 days), patients in the arm A will receive treatment based on the Guardant360 Response assay results, as described below. Arm B will continue the immunotherapy only.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Arm A
Arm A - Intervention arm (Immunotherapy and Chemotherapy)
Nivolumab 360 mg/kg every 3 weeks Ipilimumab 1 mg/kg every 6 weeks
Platinum- doublet Chemotherapy (Histology-based) 4 cycles depending on the investigator's discretion.
Carboplatin dosed at AUC 5, and either Paclitaxel 175 mg/m2 for squamous or Pemetrexed 500 mg/m2 for non-squamous
Group Type
ACTIVE_COMPARATOR
Nivolumab
Intervention Type
DRUG
Immunotherapy
Ipilimumab
Intervention Type
DRUG
Immunotherapy
Carboplatin
Intervention Type
DRUG
Chemotherapy
Paclitaxel
Intervention Type
DRUG
Chemotherapy
Pemetrexed
Intervention Type
DRUG
Chemotherapy
Arm B
Arm B - control arm (Immunotherapy only)
Nivolumab 360 mg/kg every 3 weeks Ipilimumab 1 mg/kg every 6 weeks
Group Type
OTHER
Nivolumab
Intervention Type
DRUG
Immunotherapy
Ipilimumab
Intervention Type
DRUG
Immunotherapy
Interventions
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Nivolumab
Immunotherapy
Intervention Type
DRUG
Ipilimumab
Immunotherapy
Intervention Type
DRUG
Carboplatin
Chemotherapy
Intervention Type
DRUG
Paclitaxel
Chemotherapy
Intervention Type
DRUG
Pemetrexed
Chemotherapy
Intervention Type
DRUG
Other Intervention Names
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Opdivo
Yervoy
Paraplatin
Taxol
Paxel
Alimta
Pemfexy
Eligibility Criteria
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Inclusion Criteria
1. Eligible patients will have newly diagnosed, previously untreated histologically documented Stage IV NSCLC
2. Eligible patients will be required to have positive PD-L1 expression ≥1% by IHC using Dako 22C3 assay.
3. Patients will require a baseline Guardant360 CDx test prior to enrollment
4. Patients willing to undergo serial ctDNA testing as required by protocol
5. Patients will be over the age of 18
6. Life expectancy ≥12 weeks
7. Measurable (RECIST 1.1) indicator lesion not previously irradiated, with measurable disease determined per the treating investigator.
8. Prior palliative radiotherapy to non-CNS lesions must have been completed at least 2 weeks prior to randomization
9. ECOG Performance Score ≤2
10. Adequate organ function
11. Hemoglobin \> 9 g/dL
12. Platelets \> 100,000mm3 or 100 x 109/L
13. AST, ALT \< 2.5 x ULN with no liver metastases or \< 5x ULN with the presence of liver metastases
14. Total bilirubin \< 1.5 x ULN if no liver metastases or \< 3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases
15. Absolute neutrophil count (ANC) \> 1500 cells/mm3
16. Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 60ml/min calculated by Cockcroft and Gault's equation
17. Willing to use highly effective contraceptive measures if child-bearing potential or if the patient's sexual partner is a woman of childbearing potential: a. Female subjects should be using a highly effective contraceptive measures, and must have a negative pregnancy test and not be breast-feeding prior to starting of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening: i. Post-menopausal is defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments ii. Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the the post-menopausal range for the institution iii. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not a tubal ligation b. Male subjects should be willing to use barrier contraception
2. Eligible patients will be required to have positive PD-L1 expression ≥1% by IHC using Dako 22C3 assay.
3. Patients will require a baseline Guardant360 CDx test prior to enrollment
4. Patients willing to undergo serial ctDNA testing as required by protocol
5. Patients will be over the age of 18
6. Life expectancy ≥12 weeks
7. Measurable (RECIST 1.1) indicator lesion not previously irradiated, with measurable disease determined per the treating investigator.
8. Prior palliative radiotherapy to non-CNS lesions must have been completed at least 2 weeks prior to randomization
9. ECOG Performance Score ≤2
10. Adequate organ function
11. Hemoglobin \> 9 g/dL
12. Platelets \> 100,000mm3 or 100 x 109/L
13. AST, ALT \< 2.5 x ULN with no liver metastases or \< 5x ULN with the presence of liver metastases
14. Total bilirubin \< 1.5 x ULN if no liver metastases or \< 3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases
15. Absolute neutrophil count (ANC) \> 1500 cells/mm3
16. Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 60ml/min calculated by Cockcroft and Gault's equation
17. Willing to use highly effective contraceptive measures if child-bearing potential or if the patient's sexual partner is a woman of childbearing potential: a. Female subjects should be using a highly effective contraceptive measures, and must have a negative pregnancy test and not be breast-feeding prior to starting of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening: i. Post-menopausal is defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments ii. Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the the post-menopausal range for the institution iii. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not a tubal ligation b. Male subjects should be willing to use barrier contraception
Exclusion Criteria
1. Patients under the age of 18
2. Inability to provide informed consent by either the patient or the authorized representative
3. Patients with known EGFR, ALK, ROS1, MET, and RET oncogenic driver alterations that have approved first-line targeted therapies are excluded from the study (All patients must have a tissue or blood-based testing to identify these driver alterations)
4. Patients with no detectable ctDNA or ctDNA VAF ≤ 0.3% on Guardant360 CDx at baseline
5. Subjects with untreated CNS metastases are excluded.
6. Subjects are eligible if CNS metastases are adequately treated and subjects are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization.
7. Subjects with carcinomatous meningitis
8. Subjects must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before randomization
9. Subjects with previous malignancies (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to randomization and no additional therapy is required or anticipated to be needed during the study period.
10. Other active malignancy requiring concurrent intervention.
11. Subjects with an active, known, or suspected autoimmune disease. Subjects with type I diabetes mellitus, and hypothyroidism only require hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
12. Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroids \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
13. Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.
14. Significant uncontrolled cardiovascular disease, including but not limited to, any of the following:
1. Uncontrolled hypertension, which is defined as systolic blood pressure \> 160 mm Hg or diastolic blood pressure \> 100 mm Hg despite optimal medical management.
2. Active coronary artery disease, including unstable all newly diagnosed angina within 3 months of study enrollment.
3. Myocardial infarction in the past 6 months.
4. History of congenital long QT syndrome.
5. History of clinically significant arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or torsade de pointes.
6. Uncontrolled heart failure, defined as class III of 4 by the New York Heart Association functional classification.
7. History of a current diagnosis of myocarditis.
15. the Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results.
16. Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
17. Subjects with Grade 2 peripheral neuropathy
18. Life expectancy \<12 weeks
2. Inability to provide informed consent by either the patient or the authorized representative
3. Patients with known EGFR, ALK, ROS1, MET, and RET oncogenic driver alterations that have approved first-line targeted therapies are excluded from the study (All patients must have a tissue or blood-based testing to identify these driver alterations)
4. Patients with no detectable ctDNA or ctDNA VAF ≤ 0.3% on Guardant360 CDx at baseline
5. Subjects with untreated CNS metastases are excluded.
6. Subjects are eligible if CNS metastases are adequately treated and subjects are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization.
7. Subjects with carcinomatous meningitis
8. Subjects must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before randomization
9. Subjects with previous malignancies (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to randomization and no additional therapy is required or anticipated to be needed during the study period.
10. Other active malignancy requiring concurrent intervention.
11. Subjects with an active, known, or suspected autoimmune disease. Subjects with type I diabetes mellitus, and hypothyroidism only require hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
12. Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroids \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
13. Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.
14. Significant uncontrolled cardiovascular disease, including but not limited to, any of the following:
1. Uncontrolled hypertension, which is defined as systolic blood pressure \> 160 mm Hg or diastolic blood pressure \> 100 mm Hg despite optimal medical management.
2. Active coronary artery disease, including unstable all newly diagnosed angina within 3 months of study enrollment.
3. Myocardial infarction in the past 6 months.
4. History of congenital long QT syndrome.
5. History of clinically significant arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or torsade de pointes.
6. Uncontrolled heart failure, defined as class III of 4 by the New York Heart Association functional classification.
7. History of a current diagnosis of myocarditis.
15. the Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results.
16. Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
17. Subjects with Grade 2 peripheral neuropathy
18. Life expectancy \<12 weeks
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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MedSIR
OTHER
Sponsor Role
collaborator
Hackensack Meridian Health
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Martin Gutierrez, MD
Role: PRINCIPAL_INVESTIGATOR
Hackensack Meridian Health
Locations
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Lombardi Comprehensive Cancer Center, Georgetown University
Washington D.C., District of Columbia, United States
Site Status
NOT_YET_RECRUITING
John Theurer Cancer Center, Hackensack Meridian Health
Hackensack, New Jersey, United States
Site Status
RECRUITING
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Site Status
NOT_YET_RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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Role: primary
551-996-2000
References
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Related Links
Access external resources that provide additional context or updates about the study.
https://clinicaltrials.gov/ct2/show/NCT00527735?term=00527735&draw=2&rank=1
National Library of Medicine (US). 2021 Aug 16 - . Identifier NCT00527735; Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC);
https://www.opdivo.com/about-opdivo/how-the-combination-works-combinationtherapy
How do OPDIVO® (nivolumab) and YERVOY® (ipilimumab) team up to fight cancer differently than chemotherapy
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro2022-0016
Identifier Type: -
Identifier Source: org_study_id
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