Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05873439
Other study ID # MCC 21525
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date May 8, 2023
Est. completion date October 2026

Study information

Verified date January 2024
Source H. Lee Moffitt Cancer Center and Research Institute
Contact Thomas Dilliing, MD
Phone 813-745-8424
Email Thomas.Dilling@moffitt.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date October 2026
Est. primary completion date October 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
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.

Locations

Country Name City State
United States Moffitt Cancer Center Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of Unacceptable Toxicity Rate of Unacceptable Toxicity will be measured during 12 week period following study enrollment. Unacceptable toxicity is defined as any grade 4 or 5 adverse event (AE) probably or definitely related to experimental dose escalated radiation therapy 12 weeks after start of treatment
Secondary Freedom from local regional progression (FFLRP) Freedom from local regional progression (FFLRP) will be defined as lack of progression as documented by response assessment imaging following completion of concurrent chemotherapy and radiation. At 2 years
Secondary Overall Survival (OS) Overall Survival (OS) will be measured from the date of first treatment to the date of death due to any cause. At 2 years
See also
  Status Clinical Trial Phase
Recruiting NCT06147570 - A Study of HS-10365 in Patients With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer Phase 2
Recruiting NCT01312337 - Iressa for EGFR Mutation Negative Non-small Cell Lung Cancer (NSCLC) Phase 2
Completed NCT05860582 - A Study of [14C]GB491 in Male Healthy Subjects Phase 1
Terminated NCT02669914 - MEDI4736 (Durvalumab) in Patients With Brain Metastasis From Epithelial-derived Tumors Phase 2
Completed NCT02562027 - SBRT (Stereotactic Body Radiation Therapy) vs. Surgery in High Risk Patients With Early Stage Lung Cancer N/A
Recruiting NCT05358249 - Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation Phase 1/Phase 2
Active, not recruiting NCT02954523 - Dasatinib and Osimertinib (AZD9291) in Advanced Non-Small Cell Lung Cancer With EGFR Mutations Phase 1/Phase 2
Terminated NCT03998189 - Metabolic and Microbial Profiling of Lung Cancer N/A
Not yet recruiting NCT03258671 - IMRT and Timing in Combination With EGFRTKI for Stage IV Non-small-cell Lung Cancer N/A
Recruiting NCT03838588 - The Tracking Molecular Evolution for NSCLC (T-MENC) Study
Active, not recruiting NCT04984811 - NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC Phase 2
Recruiting NCT05688280 - Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With CRC, NSCLC, and STS Phase 1/Phase 2
Recruiting NCT02951611 - Effects of Acupuncture Stimulation on Systemic Inflammation N/A
Recruiting NCT02974933 - Apatinib Mesylate Combined With Pemetrexed in the Treatment of Pretreated Advanced Non-squamous Non-small Cell Lung Cancer Phase 2
Active, not recruiting NCT02980536 - cSMART Liquid Biopsy and Dynamic Monitor of NSCLC Patients in Inner-Mongolia China
Completed NCT02972216 - Post-marketing Surveillance Study of Docetaxel-Based Chemotherapy Phase 4
Recruiting NCT02905591 - A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC Phase 2
Active, not recruiting NCT02981108 - A Study to Evaluate Safety, PK and Efficacy of HS-10296 in Patients With NSCLC Phase 1/Phase 2
Active, not recruiting NCT02299141 - Nintedanib in Molecularly Selected Patients With Advanced Non-Small Cell Lung Cancer Phase 2
Recruiting NCT04900935 - Patient-centered, Optimal Integration of Survivorship and Palliative Care N/A