This phase II trial studies how well platinum-based chemotherapy works when given together
with durvalumab in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Drugs used in chemotherapy, such as carboplatin, paclitaxel, and pemetrexed, 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. Immunotherapy with monoclonal
antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may
interfere with the ability of tumor cells to grow and spread. The purpose of this study is to
find out if the combination of chemotherapy in combination with the immune therapy drug
durvalumab would be efficacious and have an acceptable toxicity profile in patients with
advanced non-small cell lung cancer.
Description
PRIMARY OBJECTIVE:
I. To determine the 6-months progression-free survival (PFS) rate with the combination of
dose attenuated doublet chemotherapy with durvalumab in advanced non-small cell lung cancer
(NSCLC) patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2
status or age >= 70.
SECONDARY OBJECTIVES:
I. To investigate overall response rate. II. To determine the safety profile of the regimen.
III. To determine the median PFS and overall survival.
EXPLORATORY OBJECTIVE:
I. Exploratory investigation of biomarkers that could potentially serve as predictive
indicators: characterize immunoprofile in peripheral blood by flow cytometry.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I (SQUAMOUS NSCLC): Patients receive carboplatin intravenously (IV) over 15-60 minutes,
paclitaxel IV over 3 hours and durvalumab IV over 1 hour on day 1. Treatment repeats every 3
weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Patients who do not progress receive durvalumab IV every 4 weeks for up to 35 cycles in the
absence of disease progression or unacceptable toxicity.
ARM II (NON-SQUAMOUS NSCLC): Patients receive carboplatin IV over 15-60 minutes, pemetrexed
IV over 10 minutes and durvalumab IV over 1 hour on day 1. Treatment repeats every 3 weeks
for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients
who do not progress receive durvalumab IV and pemetrexed IV every 3 weeks for up to 35 cycles
in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
Details
Condition
Stage IV Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, Lung Non-Small Cell Carcinoma
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