Stage IV Lung Non-Small Cell Cancer AJCC v7 Clinical Trial
Official title:
A Phase II Randomized, Double-Blind, Placebo-Controlled Study Evaluating Nintedanib Versus Placebo as Prophylaxis Against Radiation Pneumonitis in Patients With Unresectable NSCLC Undergoing Chemoradiation Therapy
This trial studies the side effects and how well nintedanib works compared to a placebo in treating against radiation-induced pneumonitis (inflammation of the lungs) in patients with non-small cell lung cancer that cannot be removed by surgery and are undergoing chemoradiation therapy. Nintedanib may help shrink or slow the growth of radiation-induced pneumonitis by blocking some of the enzymes needed for cells to grow and may prevent the growth of new blood vessels. It may also help reduce the recurrence of non-small cell lung cancer.
PRIMARY OBJECTIVES:
I. To evaluate the safety of the combination of durvalumab with nintedanib in patients with
unresectable Stage II/III/oligometastatic IV non-small cell lung carcinoma (NSCLC). (Phase I)
II. To compare the rate of symptomatic radiation pneumonitis at 6 months after completion of
chemoradiation in patients with unresectable stage II/III/ oligometastatic IV NSCLC who
completed chemoradiation followed by nintedanib versus placebo. (Phase II)
SECONDARY OBJECTIVES:
I. To compare the quality of life (QOL) in patients who received nintedanib versus placebo
during active treatment until 6 months after completion of treatment.
II. To compare the progression-free survival, overall survival and 1-year progression-free
survival rate in patients who received nintedanib versus placebo.
III. To compare pulmonary function test (PFT) results and radiation pneumonitis (RP) score in
patients who received nintedanib versus placebo.
IV. To compare the composite index (based on PFT, RP score and QOL) at the end of active
treatment and 6 months after completion of treatment between patients who received nintedanib
versus placebo.
EXPLORATORY OBJECTIVES:
I. To investigate blood-based biomarkers in evaluating risk of developing radiation
pneumonitis as well as the efficacy of nintedanib.
OUTLINE: This is a phase I, dose-escalation study of nintedanib followed by a phase II study.
Patients who are not receiving durvalumab as standard of care prior to establishment of the
recommended phase II dose are randomized to 1 of 2 arms. Patients receiving durvalumab are
assigned to Arm III.
ARM I: Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib
orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 6
cycles in the absence of disease progression or unacceptable toxicity.
ARM II: Beginning 4-8 weeks after completion of radiation therapy, patients receive placebo
capsules PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the
absence of disease progression or unacceptable toxicity.
ARM III: Beginning 4-8 weeks after completion of radiation therapy, patients receive
nintedanib PO BID on days 1-28 and standard of care durvalumab intravenously (IV) over 60
minutes on days 1 and 15. Treatment with nintedanib repeats every 28 days for up to 6 cycles
and treatment with durvalumab repeats every 2 weeks in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, between 76-97 days,
between 166-187 days, and then between 2.5 years.
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