This is a prospective, multi-center, single arm study assessing the efficacy and safety of durvalumab given concurrently with platinum-based CRT (durvalumab + SoC CRT) in patients with locally advanced, unresectable NSCLC (Stage III).
Approximately 35 patients with locally advanced, unresectable NSCLC (Stage III) who are eligible to receive platinum-based CRT will be enrolled in and receive durvalumab + SoC CRT. Patients with CR, partial response (PR), or stable disease (SD)based on Investigator assessment at the 16-week tumor evaluation following completion of SoC CRT will continue to receive durvalumab as consolidation treatment. Patients with RECIST 1.1-defined radiological progressive disease (PD) will proceed to follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Durvalumab (intravenous infusion)
Carboplatin /Paclitaxel, as per standard of care
Pemetrexed / Cisplatin, as per standard of care
Henan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGShanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGGrade ≥3 immune-mediated Adverse event
Grade ≥3 immune-mediated Adverse event
Time frame: From the date of first dose until disease progression,assessed up to 4 years
Progression-free survival (PFS)
Progression-free survival
Time frame: From date of first dose until the date of objective disease progression or death,assessed up to 4 years
Overall Survival (OS)
Overall Survival
Time frame: From the date of first dose until death due to any cause,assessed up to 4 years
Objective response rate(ORR)
Objective response rate
Time frame: From the date of first dose until the date of objective disease progression or death,assessed up to 4 years
Duration of response(DOR)
Duration of response
Time frame: From the date of first documented response (RECIST 1.1.) until the first date of documented progression or death in the absence of disease progression,assessed up to 4 years
Disease control rate(DCR)
Disease control rate
Time frame: From the date of first dose until 24 weeks.
Time to death or distant metastasis(TTDM)
Time to death or distant metastasis
Time frame: From the date of first dose to until the first date of distant metastasis or death in the absence of distant metastasis,assessed up to 4 years
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Pemetrexed / Carboplatin , as per standard of care
5 fractions/ week for \~6 weeks (±3 days) (Total 60 Gy)