RECRUITING

BrUOG 397: NEO Rad (LOW): Neoadjuvant Low Dose Stereotactic Body Radiotherapy, Ipilimumab and Nivolumab

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Conditions

Non Small Cell Lung Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This single-arm phase 2 study will enroll patients with resectable and operable stage IB - III non-small cell lung cancer and treat them with pre-operative ipilimumab + nivolumab plus low-dose stereotactic body radiation therapy (SBRT) delivered concurrently. Only patients who proceed to surgery will be evaluable for the primary endpoint. The primary efficacy outcome measurement will be pathologic response (including Major Pathologic Response (MPR), and Complete Pathologic Response (CPR)). Secondary outcome measures include safety, and exploratory biomarkers of immune response in pre- and post-operative blood and tissue. A two-stage design will stop the study if fewer than 3 of the first 9 evaluable patients do not achieve MPR. An early stopping rule for safety will stop the study if more than 12 patients are enrolled to find the first 9 evaluable patients.

Official Title

BrUOG 397: NEO Rad (LOW): Neoadjuvant Low Dose Stereotactic Body Radiotherapy, Ipilimumab and Nivolumab for Patients With Resectable Stage IB - III Non-Small Cell Lung Cancer

Quick Facts

Study Start:2021-10-05
Study Completion:2025-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04933903

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Pathologically confirmed NSCLC
  2. 2. Age \> 18
  3. 3. ECOG Performance Status 0-1.
  4. 4. Pulmonary function capacity capable of tolerating the proposed lung resection. FEV1 at least 2 L. If less than 2 L, the predicted postoperative forced expiratory volume in 1 second (FEV1) must be \> 0.8 L or be \> 35% of the predicted value. Postoperative predicted DLCO ≥ 35% is required.
  5. 5. Resectable stage IB-IIIB (T2-3N0, T1-T3N1-2) NSCLC (per the 8th Edition American Joint Committee on Cancer (AJCC) classification) who are candidates for surgery with intent of R0 resection. Invasive T3 disease (eg, phrenic nerve, pericardium, chest wall other than Pancoast superior sulcus) may be included if the surgeon and study team deem it to be resectable.
  6. 6. N2 nodes must be discrete (ie, not invading surrounding structures). If patients have N2 disease, as suspected by CT or PET, histologic proof of N2 status is recommended.
  7. 7. Patients must be evaluated by a Thoracic Surgeon prior to registration. Operability is defined as having adequate pulmonary, cardiac, renal, nutritional, musculoskeletal, neurologic, and cognitive capacity to undergo major pulmonary resection with acceptable morbidity and mortality. Absence of major associated comorbidities that increase the surgery risk to an unacceptable level.
  8. 8. No prior history of thoracic radiation.
  9. 9. Adequate Organ and marrow function as defined below
  10. * leukocytes ≥2,000/mcL,
  11. * absolute neutrophil count ≥1,000/mcL,
  12. * platelets ≥100,000/mcL,
  13. * Hemoglobin \>8.0 g/dL
  14. * Total bilirubin within normal institutional limits
  15. * AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
  16. * creatinine within normal institutional limits OR creatinine clearance ≥50 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
  17. 10. Patients are capable of giving informed consent and/or have an acceptable surrogate capable of giving consent on the subject's behalf.
  18. 11. Nonpregnant and non-nursing. The effect of ipilimumab and nivolumab on the fetus is unknown.
  19. 12. Women of childbearing potential (WOCBP) must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 5 months after the last dose of study medication. Patients of childbearing potential are those who have not been surgically sterilized or have not been free of menses \>1 year.
  20. 13. Evidence of postmenopausal status or negative urinary or serum pregnancy test for female premenopausal patients. Women will be considered postmenopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
  21. 14. Women \<50 years of age would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the postmenopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
  22. 15. Women ≥50 years of age would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \>1 year ago, had chemotherapy-induced menopause with last menses \>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
  23. 16. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
  24. 17. Male patients must agree to use an adequate method of contraception starting with the first dose of study therapy through 7 months after the last dose of study therapy.
  1. 1. Pathologically confirmed NSCLC \*
  2. 2. Age \> 18 \*
  3. 3. ECOG Performance Status 0-1.
  4. 4. Pulmonary function capacity capable of tolerating the proposed lung resection. FEV1 at least 2 L. If less than 2 L, the predicted postoperative forced expiratory volume in 1 second (FEV1) must be \> 0.8 L or be \> 35% of the predicted value. Postoperative predicted DLCO ≥ 35% is required.
  5. 5. Resectable stage IB-IIIB (T2-3N0, T1-T3N1-2) NSCLC (per the 8th Edition American Joint Committee on Cancer (AJCC) classification) who are candidates for surgery with intent of R0 resection. Invasive T3 disease (eg, phrenic nerve, pericardium, chest wall other than Pancoast superior sulcus) may be included if the surgeon and study team deem it to be resectable.
  6. 6. N2 nodes must be discrete (ie, not invading surrounding structures). If patients have N2 disease, as suspected by CT or PET, histologic proof of N2 status is recommended.
  7. 7. Patients must be evaluated by a Thoracic Surgeon prior to registration. Operability is defined as having adequate pulmonary, cardiac, renal, nutritional, musculoskeletal, neurologic, and cognitive capacity to undergo major pulmonary resection with acceptable morbidity and mortality. Absence of major associated comorbidities that increase the surgery risk to an unacceptable level. \*
  8. 8. No prior history of thoracic radiation.
  9. 9. Adequate Organ and marrow function as defined below
  10. * leukocytes ≥2,000/mcL,
  11. * absolute neutrophil count ≥1,000/mcL,
  12. * platelets ≥100,000/mcL,
  13. * Hemoglobin \>8.0 g/dL
  14. * Total bilirubin within normal institutional limits
  15. * AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
  16. * creatinine within normal institutional limits OR creatinine clearance ≥50 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
  17. 10. Patients are capable of giving informed consent and/or have an acceptable surrogate capable of giving consent on the subject's behalf.
  18. 11. Nonpregnant and non-nursing. The effect of ipilimumab and nivolumab on the fetus is unknown.
  19. 12. Women of childbearing potential (WOCBP) must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 5 months after the last dose of study medication. Patients of childbearing potential are those who have not been surgically sterilized or have not been free of menses \>1 year.
  20. 13. Evidence of postmenopausal status or negative urinary or serum pregnancy test for female premenopausal patients. Women will be considered postmenopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
  21. 14. Women \<50 years of age would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the postmenopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
  22. 15. Women ≥50 years of age would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \>1 year ago, had chemotherapy-induced menopause with last menses \>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
  23. 16. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
  24. 17. Male patients must agree to use an adequate method of contraception starting with the first dose of study therapy through 7 months after the last dose of study therapy.

Contacts and Locations

Study Contact

BrUOG
CONTACT
401-863-3000
BrUOG@Brown.edu

Principal Investigator

Christopher G Azzoli, MD
PRINCIPAL_INVESTIGATOR
Brown University
Thomas A DiPetrillo, MD
PRINCIPAL_INVESTIGATOR
Brown University

Study Locations (Sites)

Rhode Island Hospital
Providence, Rhode Island, 02903
United States

Collaborators and Investigators

Sponsor: Brown University

  • Christopher G Azzoli, MD, PRINCIPAL_INVESTIGATOR, Brown University
  • Thomas A DiPetrillo, MD, PRINCIPAL_INVESTIGATOR, Brown University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-05
Study Completion Date2025-04-01

Study Record Updates

Study Start Date2021-10-05
Study Completion Date2025-04-01

Terms related to this study

Additional Relevant MeSH Terms

  • Non Small Cell Lung Cancer