Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2026-02-21 @ 9:49 AM
Study NCT ID:
NCT03366766
Status:
COMPLETED
Last Update Posted:
2023-04-03
First Post:
2017-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Organization:
Study Overview
Official Title:
Nivolumab Plus Cisplatin/Pemetrexed or Cisplatin/Gemcitabine as Induction in Resectable Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: