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
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|ClinicalTrials.gov Identifier: NCT03366766|
Recruitment Status : Active, not recruiting
First Posted : December 8, 2017
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non-Squamous Non-Small Cell Lung Carcinoma Stage I Non-Small Cell Lung Cancer Stage IA Non-Small Cell Lung Carcinoma Stage IB Non-Small Cell Lung Carcinoma Stage II Non-Small Cell Lung Cancer Stage IIA Non-Small Cell Lung Carcinoma Stage IIB Non-Small Cell Lung Carcinoma Stage IIIA Non-Small Cell Lung Cancer||Biological: Nivolumab Drug: Cisplatin Drug: Pemetrexed Disodium Drug: Gemcitabine Hydrochloride||Phase 2|
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.
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.
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 (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nivolumab Plus Cisplatin/Pemetrexed or Cisplatin/Gemcitabine as Induction in Resectable Non-Small Cell Lung Cancer|
|Actual Study Start Date :||December 20, 2017|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2022|
Experimental: Cohort I (nivolumab, cisplatin, pemetrexed disodium)
Patients with non-squamous lung cancer receive nivolumab IV over 30 minutes, cisplatin IV over 60-120 minutes, and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity
Drug: Pemetrexed Disodium
Experimental: Cohort I (nivolumab, cisplatin, gemcitabine hydrochloride)
Patients with squamous lung cancer receive nivolumab IV over 30 minutes on day 1, cisplatin IV over 60-120 minutes on day 1, and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity.
Drug: Gemcitabine Hydrochloride
- Major pathologic response (mpCR) defined as < 10% viable tumor [ Time Frame: Up to 63 days ]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
- Incidence of adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 [ Time Frame: Up to 6 months ]Safety data will be summarized descriptively.
- Progression free survival [ Time Frame: At 1 year ]The distribution of progression-free survival will be estimated using the Kaplan-Meier method.
- Overall survival [ Time Frame: Up to 6 months ]The distribution of overall survival will be estimated using the Kaplan-Meier method.
- Overall clinical response [ Time Frame: Up to 6 months ]Will be summarized by presence of baseline measurable disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03366766
|United States, Pennsylvania|
|Abington Hospital - Jefferson Health|
|Abington, Pennsylvania, United States, 19001|
|Sidney Kimmel Cancer Center at Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Rita Axelrod, MD||Sidney Kimmel Cancer Center at Thomas Jefferson University|