Genomically Guided Radiation Dose Personalization in Locally Advanced NSCLC

NCT ID: NCT05873439

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-25
• Study Completion Date: 2024-08-21

Brief 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).

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: RSI predicts dose ≤ 60 Gy

Participants will receive standard RT dose of 60Gy in 30 fractions targeting the primary tumor and any involved regional lymph nodes.

Group Type: EXPERIMENTAL

Genomically Guided Radiation Therapy (RT)

Intervention Type: RADIATION

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 B: RSI predicts dose > 60 Gy

Participants will receive treatment with RxRSI guided boost to the primary tumor up to 81Gy (2.7Gy/fraction).

Group Type: EXPERIMENTAL

Genomically Guided Radiation Therapy (RT)

Intervention Type: RADIATION

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 C: unable to calculate RSI

Participants in will receive standard RT dose of 60Gy in 30 fractions targeting the primary tumor and any involved regional lymph nodes.

Group Type: EXPERIMENTAL

Genomically Guided Radiation Therapy (RT)

Intervention Type: RADIATION

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.

Interventions

Genomically Guided Radiation Therapy (RT)

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.

Intervention Type: RADIATION

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Dilling, MD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

Moffitt Cancer Center

Tampa, Florida, United States

Countries

United States

Related Links

https://moffitt.org/clinicaltrialssearch?DiseaseSite=&q=21525

Moffitt Cancer Center Clinical Trial Search

Other Identifiers

MCC 21525

Identifier Type: -

Identifier Source: org_study_id