Genomically Guided Radiation Dose Personalization in Locally Advanced NSCLC

Trial Title: Genomically Guided Radiation Dose Personalization in Locally Advanced NSCLC

NCT ID: NCT05873439

Condition: Nonsmall Cell Lung Cancer
Nonsmall Cell Lung Cancer, Stage II
Nonsmall Cell Lung Cancer Stage III
Unresectable Non-Small Cell Lung Carcinoma

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

Conditions: Keywords:
Lung Cancer

Study type: Interventional

Study phase: Early Phase 1

Overall status: Active, not recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Genomically Guided Radiation Therapy (RT)
Description: Based on the Radiosensitivity Index (RSI) from testing participants tumor sample, participants will receive either standard dose radiation therapy, which is a strength 60Gy or up to 81Gy strength. Radiation treatment is administered 5 days per week for approximately 6 weeks.
Arm group label: Arm A: RSI predicts dose ≤ 60 Gy
Arm group label: Arm B: RSI predicts dose > 60 Gy
Arm group label: Arm C: unable to calculate RSI

Summary: The purpose of the study is to determine the feasibility of genomically guided radiation therapy (RT) with concurrent chemotherapy in the management of stage II and III non-small cell lung cancer (NSCLC).

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Diagnosis of AJCC Stage 2 or Stage 3 unresectable NSCLC as determined by a multidisciplinary oncology team - Confirmation of NSCLC with availability of fresh tumor biopsy by tissue biopsy which can include adenocarcinoma, squamous cell, large cell carcinoma, or NSCLC not otherwise specified - Life expectancy >12 weeks - Normal renal (creatinine <1.5 × upper limit of normal [ULN]), liver (bilirubin < 1.5 × ULN, transaminases <3.0 × ULN, except in known hepatic disease, wherein may be <5 × ULN) and blood counts (white blood cells ≥2.5, neutrophils ≥1000, platelets ≥50, 000, hemoglobin ≥8) - ECOG 0-1 - Age ≥ 18 years - Participants with surgery within 14 days should have recovered from all effects of the surgery and be cleared by their surgeon - There is no limit on prior systemic or therapies - Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study - Ability to sign an informed consent form, which can be signed by a family member or health care proxy. Informed consent must be given before any study related procedures occur. Exclusion Criteria: - Current or prior participation in a study of an investigational agent or investigational device within 2 weeks of the first dose of study treatment - Major surgery or significant traumatic injury that has not been recovered from 14 days before the initiation of study drug - Women who are pregnant or breastfeeding - History of allergy or hypersensitivity to any of the study drugs or study drug components - Concurrent brain metastases or leptomeningeal disease - History of prior malignancy within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS of > 90%), such as but not limited to, non-melanoma skin carcinoma, ductal carcinoma in situ, or stage I endometriod uterine cancer, and others at the discretion of the PI - Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion: - • Patients with vitiligo or alopecia - • Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement - • Any chronic skin condition that does not require systemic therapy - • Patients without active disease in the last 5 years may be included but only after consultation with the Principal Investigator - • Patients with celiac disease controlled by diet alone - Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion: - • Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection) - • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent - • Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Moffitt Cancer Center

Address:
City: Tampa
Zip: 33612
Country: United States

Start date: May 25, 2023

Completion date: October 2026

Lead sponsor:
Agency: H. Lee Moffitt Cancer Center and Research Institute
Agency class: Other

Source: H. Lee Moffitt Cancer Center and Research Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05873439
https://moffitt.org/clinicaltrialssearch?DiseaseSite=&q=21525