Comparing Hypo-fractionated Intensity- Modulated Radiatio... | NCT04992780

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypo-Fractionation	Experimental	Participants will receive one fraction of radiation therapy a day for 5 days each week for 5 weeks along with weekly chemotherapy with Paclitaxel 45 milligram per meter squared (mg/m2) through intravenous (IV)infusion for 1 hour followed by Carboplatin area under the curve (AUC) 2 IV for 30 minutes for approximately 5 or 6 weeks. Once complete, participant will receive Durvalumab, 1500 mg, IV every 4 weeks for 12 months.	Radiation: Hypo-Fractionation
Standard-Fractionation	Active Comparator	Participants will receive one fraction of radiation therapy a day for 5 days each week for 6 weeks along with weekly chemotherapy with Paclitaxel 45 milligram per meter squared (mg/m2) through intravenous (IV)infusion for 1 hour followed by Carboplatin AUC 2 IV for 30 minutes for approximately 5 or 6 weeks. Once complete, participant will receive Durvalumab, 1500 mg, IV every 4 weeks for 12 months.	Radiation: Standard-Fractionation

Name	Type	Description	Arm Group Labels	Other Names
Hypo-Fractionation	Radiation	62.5 Gy in 25 fractions of 2.5 Gy/fraction	Hypo-Fractionation

Measure	Description	Time Frame
Locoregional control (LRC)	RECIST 1.1	From enrollment for up to 7.5 years

Measure	Description	Time Frame
Acute toxicities	CTCAE v. 5.0	From enrollment for up to 7.5 years
Late toxicities	CTCAE v. 5.0	From enrollment for up to 7.5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
Males and females age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2
Measurable disease by RECIST 1.1
Women of childbearing potential must have a negative serum pregnancy test within one month prior to initiating treatment
Pathologically proven diagnosis of Stage IIIA or IIIB non-small cell lung cancer (NSCLC)
No Positron Emission Tomography (PET)/CT evidence of metastatic disease
An MRI of the brain with contrast excluding intracranial metastatic disease (or CT with contrast if MRI is medically contraindicated). An MRI without contrast is only permitted if the subject cannot have contrast for medical reasons
If a pleural effusion is present, it must be tapped and confirmed to be cytologically negative. If an effusion is deemed too small to safely tap, the subject will be eligible
Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed in Child-Bearing Potential/Pregnancy section for the duration of study participation and for 90 days following completion of therapy
Adequate organ function per laboratory results

Exclusion Criteria:

Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study
Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
Evidence of severe or systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) that would interfere with study protocol as judged by the investigator
Is pregnant or breastfeeding
Active connective tissue disorders, such as active lupus or scleroderma
Known Acquired Immune Deficiency (HIV (+)/AIDS)
Has a known allergic reaction to any excipient contained in the study drug formulations
Active Grade 3 (per the NCI CTCAE, Version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment
Prior thoracic radiotherapy