genomically guided radiation dose personalization in locally advanced nsclc

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

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).


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)

Keywords: lung cancer