RECRUITING

NBTXR3 and Radiation Therapy for the Treatment of Inoperable Recurrent Non-small Cell Lung Cancer

Conditions

Recurrent Lung Non-Small Cell Carcinoma Stage I Lung Cancer AJCC v8 Stage IA1 Lung Cancer AJCC v8 Stage IA2 Lung Cancer AJCC v8 Stage IA3 Lung Cancer AJCC v8 Stage IB Lung Cancer AJCC v8 Stage II Lung Cancer AJCC v8 Stage IIA Lung Cancer AJCC v8 Stage IIB Lung Cancer AJCC v8 Stage III Lung Cancer AJCC v8 Stage IIIA Lung Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8 Stage IIIC Lung Cancer AJCC v8 Unresectable Lung Non-Small Cell Carcinoma

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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 phase I trial investigates the best dose and side effects of NBTXR3 when given together with radiation therapy for the treatment of non-small cell lung cancer that cannot be treated by surgery (inoperable) and has come back (recurrent). NBTXR3 is a radio-enhancer designed to increase the radiotherapy energy dose deposition inside tumor cells. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving NBTXR3 and radiation therapy may increase radiation-dependent tumor cell killing without increasing the radiation exposure of healthy surrounding tissues.

Official Title

Phase I Study of Reirradiation With NBTXR3 for Inoperable Locoregional Recurrent Non-Small Cell Lung Cancer (NSCLC)

Quick Facts

Study Start:2021-02-10

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04505267

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 Criteria	Exclusion Criteria
1. Biopsy proven locoregionally recurrent NSCLC after prior definitive radiation therapy, or patients that have imaging characteristics highly suggestive of recurrence but no pathologic or cytologic diagnosis. Pathologic diagnosis will be confirmed during the procedure to inject NBTXR3, prior to injecting the drug. If pathologic diagnosis cannot be established, the procedure will be aborted and the patient will be considered a screening failure. For stage IV patients, oligometastatic disease should be confirmed at screening. Oligometastatic disease is defined as ≤ 3 cancer lesions, not including the primary tumor. 2. Participant deemed medically inoperable by the investigator or treating physician. 3. Overlap between recurrent disease in need of treatment and prior radiation treatment field as determined by treating Radiation Oncologist. 1. As a general reference, recurrent disease within 50% isodose line of prior radiation treatment field would be considered significant. 2. Radiation treatment received more than 6 months prior to enrollment. 4. Amenable to undergo bronchoscopic (EBUS, CBCT) or CT-guided injection of NBTXR3 as per investigator or treating physician. 1. Up to 4 lung lesions may be injected with NBTXR3, including the primary tumor, involved lymph node(s), and/or metastatic lesion(s). 2. At least 1 injected lesion should be located within a reirradiation field. 3. All injected lesions must be radiated. 5. The target lesion(s) should be measurable on cross sectional imaging (RECIST 1.1). 6. Age ≥ 18 years 7. ECOG Performance Status 0-2 8. For cohort 1, adequate laboratory values to receive radiation as determined by the principal investigator or treating physician. 9. For cohort 2 laboratory values at screening: 1. Hemoglobin ≥ 8.0 g/dL 2. Absolute Neutrophil Count (ANC) ≥ 1,500/mm3 3. Platelet Count ≥ 100,000/mm3 4. Creatinine ≤ 1.5 x upper limit of normal (ULN) 5. Calc. Creatinine Clearance ≥ 30 mL/min 6. Total Bilirubin ≤ 2.0 mg/dL 7. AST / ALT ≤ 3.0 x upper limit of normal (ULN) or 5.0 x ULN if known liver metastases 8. Serum albumin ≥ 3.0 g/dL 10. Negative urine or serum pregnancy test ≤ 7 days of NBTXR3 injection in all female of child-bearing potential. 11. Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study. 12. English speaking or Non-English Speaking subjects	1. At screening, past medical history of: 2. Has received any approved or investigational anti-neoplastic or immunotherapy agent within 3 weeks prior to NBTXR3 injection 3. Use of concurrent systemic therapy (chemotherapy, immunotherapy, targeted therapy) or patient participation on another therapeutic clinical trial. 4. Active malignancy, in addition to locoregionally recurrent NSCLC, with the exception of definitively treated and relapse free within 1 year from diagnosis of non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or patients with another primary malignancy who are definitively treated and relapse free with at least 2 years elapsed since the diagnosis of the other primary malignancy. 5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia, or psychiatric illness that would limit compliance with treatment. 6. Known active, uncontrolled (high viral load) HIV or hepatitis B or hepatitis C infection 7. Female patients who are pregnant or breastfeeding. 8. Women of child-bearing potential and their male partners who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period. Acceptable methods of contraception are those that, alone or in combination, result in a failure rate of \< 1% per year when used consistently and correctly. 9. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. 10. Cognitively impaired subjects

Inclusion Criteria

Exclusion Criteria

1. Biopsy proven locoregionally recurrent NSCLC after prior definitive radiation therapy, or patients that have imaging characteristics highly suggestive of recurrence but no pathologic or cytologic diagnosis. Pathologic diagnosis will be confirmed during the procedure to inject NBTXR3, prior to injecting the drug. If pathologic diagnosis cannot be established, the procedure will be aborted and the patient will be considered a screening failure. For stage IV patients, oligometastatic disease should be confirmed at screening. Oligometastatic disease is defined as ≤ 3 cancer lesions, not including the primary tumor.
2. Participant deemed medically inoperable by the investigator or treating physician.
3. Overlap between recurrent disease in need of treatment and prior radiation treatment field as determined by treating Radiation Oncologist.
1. As a general reference, recurrent disease within 50% isodose line of prior radiation treatment field would be considered significant.
2. Radiation treatment received more than 6 months prior to enrollment.
4. Amenable to undergo bronchoscopic (EBUS, CBCT) or CT-guided injection of NBTXR3 as per investigator or treating physician.
1. Up to 4 lung lesions may be injected with NBTXR3, including the primary tumor, involved lymph node(s), and/or metastatic lesion(s).
2. At least 1 injected lesion should be located within a reirradiation field.
3. All injected lesions must be radiated.
5. The target lesion(s) should be measurable on cross sectional imaging (RECIST 1.1).
6. Age ≥ 18 years
7. ECOG Performance Status 0-2
8. For cohort 1, adequate laboratory values to receive radiation as determined by the principal investigator or treating physician.
9. For cohort 2 laboratory values at screening:
1. Hemoglobin ≥ 8.0 g/dL
2. Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
3. Platelet Count ≥ 100,000/mm3
4. Creatinine ≤ 1.5 x upper limit of normal (ULN)
5. Calc. Creatinine Clearance ≥ 30 mL/min
6. Total Bilirubin ≤ 2.0 mg/dL
7. AST / ALT ≤ 3.0 x upper limit of normal (ULN) or 5.0 x ULN if known liver metastases
8. Serum albumin ≥ 3.0 g/dL
10. Negative urine or serum pregnancy test ≤ 7 days of NBTXR3 injection in all female of child-bearing potential.
11. Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.
12. English speaking or Non-English Speaking subjects

1. At screening, past medical history of:
2. Has received any approved or investigational anti-neoplastic or immunotherapy agent within 3 weeks prior to NBTXR3 injection
3. Use of concurrent systemic therapy (chemotherapy, immunotherapy, targeted therapy) or patient participation on another therapeutic clinical trial.
4. Active malignancy, in addition to locoregionally recurrent NSCLC, with the exception of definitively treated and relapse free within 1 year from diagnosis of non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or patients with another primary malignancy who are definitively treated and relapse free with at least 2 years elapsed since the diagnosis of the other primary malignancy.
5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia, or psychiatric illness that would limit compliance with treatment.
6. Known active, uncontrolled (high viral load) HIV or hepatitis B or hepatitis C infection
7. Female patients who are pregnant or breastfeeding.
8. Women of child-bearing potential and their male partners who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period. Acceptable methods of contraception are those that, alone or in combination, result in a failure rate of \< 1% per year when used consistently and correctly.
9. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
10. Cognitively impaired subjects

Contacts and Locations

Principal Investigator

Saumil Gandhi

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Saumil Gandhi, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

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 Date2021-02-10

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2021-02-10

Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

Recurrent Lung Non-Small Cell Carcinoma
Stage I Lung Cancer AJCC v8
Stage IA1 Lung Cancer AJCC v8
Stage IA2 Lung Cancer AJCC v8
Stage IA3 Lung Cancer AJCC v8
Stage IB Lung Cancer AJCC v8
Stage II Lung Cancer AJCC v8
Stage IIA Lung Cancer AJCC v8
Stage IIB Lung Cancer AJCC v8
Stage III Lung Cancer AJCC v8
Stage IIIA Lung Cancer AJCC v8
Stage IIIB Lung Cancer AJCC v8
Stage IIIC Lung Cancer AJCC v8
Unresectable Lung Non-Small Cell Carcinoma