Phase 2 N=21 Treatment

Hypofractionated Boost Before Chemoradiation for Patients With Stage II-III Non-small Cell Lung Cancer Unsuitable for Surgery

Recurrent Non-small Cell Lung Cancer · Stage IIA Non-small Cell Lung Cancer · Stage IIB Non-small Cell Lung Cancer · Stage IIIA Non-small Cell Lung Cancer · Stage IIIB Non-small Cell Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02262325 ↗

Enrolled (actual)

Serious AEs

42.9%

Results posted

Jun 2025

Primary outcome: Primary: Primary Tumor Control Rate, as Measured From the Time of Treatment Completion Until the First Documented Date of Local Failure — 100 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: hypofractionated radiation therapy (Radiation); cisplatin (Drug); etoposide (Drug); 3-dimensional conformal radiation therapy (Radiation); laboratory biomarker analysis (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ohio State University Comprehensive Cancer Center
Primary completion: Apr 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Primary Tumor Control Rate, as Measured From the Time of Treatment Completion Until the First Documented Date of Local Failure	100	—
SECONDARY Number of Adverse Events	2; 1; 1; 1; 2; 11	—
SECONDARY Tolerability Measured by the Number of Patients Who Discontinue Treatment	—	—
SECONDARY Regional Control	81.6	—
SECONDARY Distant Control	70.3	—
SECONDARY Disease-free Survival (DFS)	46.1	—
SECONDARY Overall Survival (OS)	50.3	—
SECONDARY Objective Response Rate as Measured by Response Evaluation Criteria in Solid Tumors Criteria	72.7; 80.0	—
SECONDARY Changes in Tumor Perfusion Measured by MR-DCE/PWI Amp and Kep	2.9; -6.8	—
SECONDARY Changes in Tumor Perfusion Measured by MR-DCE/PWI Kpe and Kel	5.1; -4.5	—
SECONDARY Changes in Diffusion Measured by MR-diffusion	23	—
SECONDARY Changes in Hypoxia Measured by BOLD Sequences	-87.1	—

Summary

This phase II trial studies how well giving a hypofractionated boost to the primary tumor before standard chemotherapy and radiation therapy works in treating patients with stage II or III non-small cell lung cancer that cannot be removed by surgery. Advances in radiation oncology have allowed better radiation targeting which may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells. Giving more precise and targeted radiation before standard chemotherapy and radiation therapy may kill more tumor cells and prevent the cancer from coming back in the location in which it started.

Eligibility Criteria

Inclusion Criteria

All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) = = 1.5 x 10^9/L
Hemoglobin >= 9 g/dL
Platelets >= 100 x 10^9/L
Total bilirubin = = 50 mL/min (calculated by the Cockcroft-Gault formula) or
24-hour urine creatinine clearance >= 50 mL/min
Non-small cell lung cancer (NSCLC), histologically and/or cytologically proven
Clinical American Joint Committee on Cancer (AJCC) stage (7th edition) IIA-IIIB NSCLC (T1-4N1-3M0)
Patients must be considered unresectable or medically-inoperable
Patients must have primary tumor = 2 years prior
Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix; patients with a previous malignancy without evidence of disease for >= 3 years will be allowed to enter the trial
History of active connective tissue disease (scleroderma) or idiopathic pulmonary fibrosis
History of previous radiation therapy which would result in overlapping radiation fields
Uncontrolled neuropathy grade 2 or greater, regardless of cause
Subjects who are breast-feeding and plan to continue breast-feeding during therapy, or have a positive pregnancy test will be excluded from the study; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, known contrast allergy to Gadolinium contrast, pregnancy, nursing mothers, weight greater than 350 pounds) [first 10 patients]
Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator; this could include severe, active co-morbidities such as:
Unstable angina and/or congestive heart failure requiring hospitalization within the last months
Transmural myocardial infarction within the last 6 months
Acquired immune deficiency syndrome (AIDS) based upon the current CDC definition; note, however, that HIV testing is not required for entry to protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved may be significantly immunosuppressive
Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
Hepatic insufficiency resulting in jaundice and/or coagulation defects

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02262325). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.