Overview

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

Status:
Active, not recruiting
Trial end date:
2022-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborator:
Bristol-Myers Squibb
Treatments:
Cisplatin
Gemcitabine
Nivolumab
Pemetrexed
Criteria
Inclusion Criteria:

- Pathologically confirmed non small cell lung cancer (NSCLC), not previously treated,
with a plan to undergo surgery

- Stage I-IIIA (stage I tumors must be >= 4 cm) per AJCC 8th edition

- Tumor sample must be available for PD-L1 testing; archival tissue within 3 months of
study enrollment will be used; if archival tissue is unavailable, a fresh biopsy will
be taken

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- While blood cells 2000/ul or more

- Absolute neutrophil count 1500/ul or more

- Platelets 100,000/ul or more

- Hemoglobin 9 g/dl or more; (transfusion permitted)

- Bilirubin less than or equal to 1.5 x the upper limit of normal (except subjects with
Gilbert syndrome, who can have total bilirubin < 3 mg/dl)

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal
to 3 x the upper limit of normal

- Glomerular filtration rate (GFR) greater than or equal to 40 ml/min using the
Cockcroft-Gault formula or serum creatinine less than or equal to 1.5 x (ULN) upper
limit of normal

- Women of reproductive potential should have a negative serum or urine pregnancy test
(minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin
[HCG]) within 21 days of the study enrollment

- Women of reproductive potential must use highly effective contraception methods to
avoid pregnancy for 23 weeks after the last dose of study drugs; "women of
reproductive potential" is defined as any female who has experienced menarche and who
has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or
who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea
in a woman over 45 in the absence of other biological or physiological causes; in
addition, women under the age of 55 must have a documented serum follicle stimulating
hormone (FSH) level more than 40 mIU/mL

- Men of reproductive potential who are sexually active with women of reproductive
potential must use any contraceptive method with a failure rate of less than 1% per
year; men who are receiving the study medications will be instructed to adhere to
contraception for 31 weeks after the last dose of study drugs; men who are azoospermic
do not require contraception

- All subjects must be able to comprehend and sign a written informed consent document

Exclusion Criteria:

- Patients who have participated in a study with an investigational agent or device
within 2 weeks of enrollment

- Any prior radiotherapy to the lung

- Any prior treatment for NSCLC

- Epidermal growth factor receptor (EGFR) or alkaline phosphatase (ALK) activating
alteration

- Any prior therapy with anti-PD-1, anti-PD-L2, anti-CTLA-4 antibody, or any other
antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint
pathways

- Any history of a sever hypersensitivity reaction to any monoclonal antibody

- Any history of allergy to the study drug components

- Any concurrent malignancies- exceptions include- basal cell carcinoma of the skin,
squamous cell carcinoma of the skin, superficial bladder cancer or in situ cervical
cancer that has undergone potentially curative therapy; patients with a history of
other prior malignancy must have been treated with curative intent and must have
remained disease-free for 3 years post-diagnosis

- Participants with an active autoimmune disease or any other condition requiring
systemic treatment with either corticosteroids within 14 days (> 10 mg daily
prednisone equivalent) or other immunosuppressive medications within 30 days of
randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10
mg daily prednisone equivalent, are permitted in the absence of active autoimmune
disease.

- Participants with type I diabetes mellitus, hypothyroidism only requiring hormone
replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring
systemic treatment, or conditions not expected to recur in the absence of an external
trigger are permitted to enroll.• Patients with evidence of interstitial lung disease
or active, non-infectious pneumonitis. Patients with a history of interstitial lung
disease or non-infectious pneumonitis requiring treatment with steroids are also
excluded.

- Patients with a known human immunodeficiency virus infection (HIV 1/2 antibodies) or
acquired immunodeficiency syndrome (HIV/AIDS), active hepatitis B (e.g., hepatitis B
surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV]
ribonucleic acid [RNA] [qualitative] is detected)

- Patients who have received a live vaccine within 30 days prior initiation of the
systemic regimen

- Patients must not be receiving any other investigational agents

- Patients with uncontrolled intercurrent illnesses including, but not limited to an
active infection requiring systemic therapy or a known psychiatric or substance abuse
disorder(s) that would interfere with cooperation with the requirements of the trial

- Women must not be pregnant (as above) or breastfeeding