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Clinical Trial 21525

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT05873439

Phase: Early Phase I
Principal Investigator: Perez, Bradford

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

A Feasibility Study of Genomically Guided Radiation Dose Personalization in the Management of Locally Advanced Non-Small Cell Lung Cancer

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).

Objective

Primary: * To evaluate the number of enrolled participants able to undergo biopsy with successful estimation of RxRSI and delivery of a clinically acceptable radiation treatment plan to deliver personalized radiotherapy among patients with unresectable locally advanced NSCLC. Secondary Objectives: * To determine safety following genomically guided dose escalation among patients with locally advanced unresectable NSCLC * To determine the two year freedom from local regional progression following genomically guided dose escalation among patients with unresectable locally advanced NSCLC. * To determine the median and 2 year OS following genomically guided dose escalation among patients with locally advanced unresectable NSCLC

Treatments

Therapies

Radiotherapy

Medications

Radiotherapy ()

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

Adequate organ function

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:

a. Patients with vitiligo or alopecia

b. Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement

c. Any chronic skin condition that does not require systemic therapy

d. 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:

a. Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection)

b. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent

c. Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)

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