This phase II trial studies how well Nivolumab, Cisplatin, and Pemetrexed Disodium or Gemcitabine Hydrochloride in treating patients with stage I-IIIA non-small cell lung cancer that can be removed by surgery. Monoclonal antibodies, such as Nivolumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as Cisplatin and Pemetrexed Disodium or Gemcitabine Hydrochloride, 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. Giving Nivolumab, Cisplatin, and Pemetrexed Disodium or Gemcitabine Hydrochloride may work better in treating patients with non-small cell lung cancer.
PRIMARY OBJECTIVES: I. To estimate major pathologic response (mpCR) in patients with newly diagnosed and untreated non-small cell lung cancer (NSCLC) stage I-IIIA treated with three courses of induction nivolumab added to either cisplatin/pemetrexed or cisplatin/gemcitabine prior to surgery. SECONDARY OBJECTIVES: I. Safety. II. Complete pathologic response at all sites of disease. III. Major pathologic response rate at primary site. IV. Clinical complete response rate. V. 1 year progression free survival (PFS). VI. Overall survival. TERTIARY OBJECTIVES: I. To explore whether PDL1 expression is associated with treatment response. II. To explore whether there is a net change in the Th1/Th2 ratio (IFN-gamma, IL-4, IL10, etc.) or cell subset frequencies (M2 monocytes, myeloid-derived suppressor cells, etc.) within a patient's peripheral blood either at baseline or in response to treatment is associated with treatment response. III. To explore whether exosomes or other immune related serum biomarkers change after combination therapy. IV. To explore the predictive value of serial cell free deoxyribonucleic acid (DNA) levels and response. V. PD-L1 assessment in tumor.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Abington Hospital - Jefferson Health
Abington, Pennsylvania, United States
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Major pathologic response (mpCR) defined as < 10% viable tumor
A minimax Simon two-stage design will be used. The mpCR rate and its associated score 95% confidence interval will be estimated using the methods
Time frame: Up to 63 days
Incidence of adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Safety data will be summarized descriptively.
Time frame: Up to 6 months
Progression free survival
The distribution of progression-free survival will be estimated using the Kaplan-Meier method.
Time frame: At 1 year
Overall survival
The distribution of overall survival will be estimated using the Kaplan-Meier method.
Time frame: Up to 6 months
Overall clinical response
Will be summarized by presence of baseline measurable disease.
Time frame: Up to 6 months
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