Research & Innovation

Lung Clinical Trials

Clinical Trials

Alliance 081105

Randomized Study of Erlotinib or VS Observation  in Patients With Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)

Physician & Study Coordinator

Study Coordinator

Vanessa Shaw, BS, RN
484-526-6038

Vanessa.Shaw@sluhn.org

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Synopsis

Treatment Agent: Erlotinib

Synopsis: The purpose of this study is to compare any good and bad effects patients may have when treated with the standard treatment against patients who are treated with the standard treatment plus erlotinib (an investigational drug). You are being asked to take part in this research study because you have early stage non-small cell lung cancer that was surgically removed and may have been treated with chemotherapy and/or radiation. The tumor removed has a mutation of a gene called EGFR (Epidermal Growth Factor Receptor). We are trying to find out if this mutation could help us make decisions about which type of treatment is best for people with your type of cancer. People not in a research study are usually not treated with anything after they finish their chemotherapy although some of them may receive radiation therapy.

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Inclusion Criteria
  • Previously registered to A151216, with the result of lung cancer harboring an EGFR exon 19 deletion or L858R mutation; the testing must have been performed by one of the following criteria:
    • Patient registered to A151216 and the assessment performed centrally by the protocol specified laboratory
    • By a local Clinical Laboratory Improvement Amendments (CLIA) certified laboratory; the report must indicate the result as well as the CLIA number of the laboratory that performed the assay; these patients will also have been registered to A151216, but can be enrolled on A081105 regardless of the central lab results
      • Patients with known resistant mutations in the EGFR tyrosine-kinase (TK) domain (T790M) are not eligible
      • Patients that are both EGFR mutant and anaplastic lymphoma kinase (ALK) rearrangements will be registered to A081105
  • Completely resected stage IB (>= 4 cm), II or IIIA non-squamous NSCLC with negative margins
  • Complete recovery from surgery and standard post-operative therapy (if required). Patients must be completely recovered from surgery at the time of randomization; the minimum time requirement between date of surgery and randomization must be at least 28 days, the maximum time requirement between surgery and randomization must be 90 days if no adjuvant chemotherapy was administered, 240 days if adjuvant chemotherapy was administered, and 300 days if adjuvant chemotherapy and radiation therapy was administered.
  • No interstitial fibrosis or lung disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • No prior or concurrent malignancies within 5 years, except non-melanoma skin carcinoma and in situ carcinomas
  • Non-pregnant and non-lactating
  • Granulocytes >= 1,500/ul
  • Platelets >= 100,000/ul
  • Total bilirubin =< 1.5 x upper limit of normal (ULN)
  • Serum glutamic oxaloacetic transaminase (SGOT) =< 1.5 x ULN
  • Serum creatinine =< 1.5 x ULN

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Alliance 151216

Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

Physician & Study Coordinator

Study Coordinator

Vanessa Shaw, BS, RN
484-526-6038

Vanessa.Shaw@sluhn.org

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Synopsis

Treatment Agent: N/A

Synopsis: The purpose of this research study is to examine lung cancer patients’ surgically removed tumors for certain genetic changes, and to possibly refer these patients to a treatment study with drugs that may specifically target tumors that have these genetic changes.

A genetic test will be done to learn if your tumor has any of these genetic changes. This test will look at the genetic material of the tumor cells. We are interested to see if your tumor tissue might have one of the following two genetic changes:

  • Genetic changes in ALK (this will be referred to as ALK )
  • Genetic changes in EGFR (this will be referred to as EGFR)

ALK and EGFR are both proteins found on the surface of cells. If your tumor is found to have one of these genetic changes you may be invited to participate na trial that will look at drugs which may target tumors that have these specific genetic changes. If your tumor is not found to have the genetic changes in ALK or EGFR, your doctor will provide you with other options for your care and you will be followed for 5 years. A doctor or research staff will contact you every 6 months for 5 years to determine the status of your cancer and your overall health. This will help doctors better understand what happens to patients receiving the standard treatment for the disease.

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Inclusion Criteria
  • Completely resected non-squamous NSCLC
  • Pathologically staged IB >= 4 cm or stage IIA-IIIA disease
  • Adequate formalin-fixed, paraffin-embedded (FFPE) tissue available for central EGFR and ALK genotyping for all patients, including those already identified to carry eligible EGFR or ALK alterations

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Exclusion Criteria
  • Clinical stage IB (>= 4 cm), II or IIIA non-squamous non-small cell lung cancer (NSCLC)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • No patients who have received neoadjuvant therapy (chemo- or radio-therapy)
  • No interstitial fibrosis or lung disease
  • No prior or concurrent malignancies within 5 years, except non-melanoma skin carcinoma or in situ carcinomas
  • No prior treatment with agents targeting EGFR mutation or ALK rearrangement
  • Non-lactating and no patients known to be pregnant
  • No patients with local genotyping showing wild-type EGFR and ALK
  • No patients with local genotyping showing a Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation
  • Completely resected non-squamous NSCLC
  • Pathologically staged IB >= 4 cm or stage IIA-IIIA disease
  • Adequate formalin-fixed, paraffin-embedded (FFPE) tissue available for central EGFR and ALK genotyping for all patients, including those already identified to carry eligible EGFR or ALK alterations

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Alliance 221504

A Randomized, Double-Blind, Placebo-Controlled Pilot Study Of An Oral, Selective Peripheral Opioid Receptor Antagonist In Advanced Non-Small Cell Lung Cancer

Physician & Study Coordinator

Physician

Neil Belman, DO

Neil Belman, DO

Study Coordinator

Vanessa Shaw, BS, RN
484-526-6038

Vanessa.Shaw@sluhn.org

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Synopsis

Treatment Agent: Naloxegol

Synopsis: The purpose of this study is to test the safety and effects of naloxegol. Naloxegol is a medicine that blocks the actions of opioids outside the brain, without interfering with the pain-relieving effect of opioids inside the brain. The researchers want to see if naloxegol will relieve some of the side effects of the opioid pain medications you are taking. They also want to see if naloxegol fights off future growth in the cancer that you have, whether or not you are taking pain medications. The effect of two different doses of naloxegol will be compared to placebo.

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Inclusion Criteria
  • Advanced (stage IIIB or IV) non-small cell lung cancer diagnosed by biopsy of the primary or metastatic site (American Joint Committee on Cancer 7.0)
  • No known presence of known EGFR or EML4-ALK driver mutations in the tumor
  • Initiation of first-line chemotherapy with a platinum-pemetrexed-based regimen within 14 days of registration or planning to initiate within 14 days after registration; no planned initiation of definitive (potentially curative) concurrent chemo-radiation
  • No prior systemic therapy for advanced NSCLC, including chemotherapy, targeted therapy or immunotherapy; prior palliative radiation permitted; prior adjuvant chemotherapy/radiation is permitted
  • No past or current use of mixed opioid agonist/opioid antagonists or other opioid antagonists
  • No methadone within 4 weeks prior to registration
  • Patients must have used opioid medication(s) for pain at some time in the 4 weeks prior to registration; current use of opioids (at the time of registration) and/or later during the course of the study is permitted but not required
  • Expected survival > 3 months
  • No concurrently active second invasive malignancies except non-melanoma skin cancer
  • No history of gastrointestinal obstruction, or conditions that increase the risk of gastrointestinal obstruction, perforation, bleeding or impairment of the gastrointestinal wall; no abdominal surgery within 60 days of registration
  • No acute gastrointestinal conditions, such as: obstruction, fecal impaction, obstipation, acute surgical abdomen, ongoing need for manual maneuvers to induce bowel movements (such as digital evacuation)
  • No conditions that may compromise blood-brain barrier permeability (e.g., multiple sclerosis, recent brain trauma, Alzheimer's disease, or uncontrolled seizures)
    • No symptomatic and untreated brain metastases; patients will be eligible for study if radiation therapy for brain metastases was completed at least 7 days prior to registration
    • Patients having received stereotactic radiation will be eligible if the radiation was completed at least 7 days prior to registration
    • Patients having undergone surgical resection of brain metastases will be eligible after they have healed and recovered from the surgical intervention sufficiently to start systemic treatment for NSCLC, as determined by a neurosurgeon
    • No known leptomeningeal carcinomatosis
  • No history of myocardial infarction =< 6 months prior to registration; no current symptomatic congestive heart failure, uncontrolled angina, or uncontrolled cardiac arrhythmias
  • No severe hepatic impairment (Child-Pugh class C) or acute liver disease
  • No known serious or severe hypersensitivity reaction to naloxegol or any of its excipients
  • No concurrent use of moderate/strong CYP3A4 inhibitors, or strong CYP3A4 inducers
  • Not pregnant and not nursing; for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required; a female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Calculated (calc.) creatinine clearance >= 60 mL/min calculated using the Cockcroft-Gault formula
  • Total bilirubin =< 1.2 x upper limit of normal (ULN) unless due to Gilbert's disease
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)

 

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AstraZeneca D9102C00001 

A Phase II Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab plus Olaparib Combination Therapy Compared with Durvalumab Monotherapy as Maintenance Therapy in Patients whose Disease has not Progressed Following Standard of Care Platinum-Based Chemotherapy with Durvalumab in First-Line Stage IV Non-Small Cell Lung Cancer (ORION)                                  

Physician & Study Coordinator

Study Coordinator

Vanessa Shaw, BS, RN
484-526-6038

Vanessa.Shaw@sluhn.org

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Synopsis

Treatment Agent: Durvalumab, Olaparib

Synopsis: You are invited to take part in this research study because you have been diagnosed with lung cancer that has spread to other parts of the body (metastatic non-small cell lung cancer). The reason for the study is to find new, more effective treatment for your disease. Whether you take part or not is completely up to you. Take the time you need to read this information and ask your study doctor any questions. You can talk to your family, friends or family doctor before you decide. If you decide to take part, you must sign this form, to show that you agree to take part and to allow us to use your personal information.

AstraZeneca AB (AstraZeneca) is doing this research to find out the effectiveness of durvalumab combined with either olaparib or placebo (inactive ingredient) in treating patients with metastatic non-small cell lung cancer who have not had worsening of their cancer after treatment with durvalumab and chemotherapy.

This research study is designed to see if durvalumab given with olaparib will work better than durvalumab alone in treating this type of cancer as a maintenance treatment after durvalumab and chemotherapy. It will also determine whether the study drugs cause any side effects.

Both durvalumab (trade name ImfinziTM) and olaparib (trade name Lynparza™) are approved drugs by United States Food and Drug Administration (US FDA). Durvalumab is approved for patients with locally advanced or metastatic urothelial carcinoma whose cancers progressed during or after platinum-based chemotherapy and for Stage III non-small cell lung cancer, but not specifically for patients with metastatic non-small cell lung cancer. Durvalumab has also been approved by the FDA and the European Medicines Agency (EMA) for the treatment of patients with locally advanced non-small cell lung cancer after chemoradiation therapy. Olaparib is approved by the FDA and other countries. Olaparib is approved for certain patients with ovarian and breast cancer, but is not approved for lung cancer. Therefore, both durvalumab and olaparib are considered experimental treatments for patients with metastatic non-small cell lung cancer whose disease has not progressed (has not gotten worse) after first being treated with chemotherapy and durvalumab. Placebo will also be used in this study, and it will look like olaparib but will not contain any active medication.

Researchers have found that sometimes the body’s own immune system may slow down or control cancer growth. Sometimes this natural immune system response stops, and the cancer is not controlled by your own immune system. Research has shown that in some patients, cancer cells and immune cells start to express signals (Programmed Cell Death Ligand 1 = PD-L1 is one of them) that stop the body’s immune system from killing the cancer. 

Durvalumab is an immunotherapy drug (a drug that targets a protein produced by the body’s defense system) that blocks PD-L1 signaling and the immune cells can once again attack the cancer and be able to prevent or slow down cancer growth. Durvalumab at 1500 mg will be administered by intravenous infusion every 3 weeks with chemotherapy (for a total of around 12 weeks), and every 4 weeks after that until you meet any treatment discontinuation criteria.

Meanwhile, researchers have also learned about the body's method to repair cells after damage. One method is through an enzyme found in the body called PARP (PARP=poly ADP ribose polymerase) which is responsible for repairing DNA/cells after damage. Olaparib is a PARP inhibitor. This means that olaparib stops PARP from working. Through blocking PARP, olaparib aims to block the repair of DNA in cancer cells, which can then cause the cancer cells to die. Also, there are also some lung cancers which contain mutations in genes that lead to incomplete repair of DNA called HRR genes [homologous recombination repair]. Recently researchers have shown that PARP inhibition can lead to tumor cell death in patients with altered DNA repair genes, and patients with HRR genes that are mutated may benefit even more from treatment with olaparib. Olaparib or placebo will be taken orally at 300mg twice a day if you make it into the maintenance phase of the study (after chemotherapy) until you meet any treatment discontinuation criteria.

If you decide to take part in this trial and if you have a specific type of lung cancer which is caused by certain genomic aberrations (genetic defect) including either ROS re-arrangement or BRAFV600E (names of specific genes) mutations, then you are choosing to forego approved therapies with demonstrated clinical benefits for cancers with these specific gene mutations.

 

 

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Inclusion Criteria

- Histologically or cytologically documented Stage IV NSCLC not amenable to curative surgery or radiation.

Patients must have tumors that lack activating EGFR mutations and ALK fusions.

  • (WHO)/(ECOG) performance status of 0 or 1
  • No prior chemotherapy or any other systemic therapy for Stage IV NSCLC
  • Adequate organ and marrow function without blood transfusions in the past 28 days,
  • At least 1 tumor lesion, not previously irradiated, that can be accurately measured as per RECIST 1.1.

Key Inclusion criteria for randomization to maintenance treatment:

  • Documented radiographic evidence of CR, PR, or Stable Disease (SD) as per Investigator-assessed RECIST 1.1 following 4 cycles of platinum-based chemotherapy.
  • Creatinine Clearance (CrCl) ≥51 mL/min calculated by Cockcroft-Gault equation or measured by 24-hour urine collection.
  • Ability to swallow whole oral medications.

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Exclusion Criteria
  • Mixed small-cell lung cancer and sarcomatoid variant NSCLC histology.
  • Prior exposure to any chemotherapy agents (except chemotherapy or chemoradiation for non-metastatic disease), polyadenosine 5'diphosphoribose [poly (ADP ribose)] polymerase (PARP) therapy, or immunomediated therapy
  • Active or prior documented autoimmune or inflammatory disorders.
  • Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of Investigational Product (IP)
  • untreated (CNS) metastases and/or carcinomatous meningitis
  • Active infection.

Exclusion criteria to be randomized to maintenance treatment:

• Inability to complete 4 cycles of platinum-based chemotherapy for any reason or discontinuation of Durvalumab during initial therapy.

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BMS CA209-234

Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice

Physician & Study Coordinator

Physician

Gary G Lu, M.D. practices Cancer – Medical Oncology in Easton and Stroudsburg

Gary Lu, MD, PhD

Study Coordinator

Linda Hosler, BA, BSN, RN

484-526-6038

Linda.Hosler@sluhn.org

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Synopsis

Treatment Agent: N/A

Synopsis:  The purpose of this study is to understand how nivolumab is used to treat patients who are diagnosed with advanced melanoma or lung cancer; and patients’ health-related experiences overall. Patients invited to participate are planning to start on nivolumab, either on its own or in combination with Ipilimumab as per routine care. The study will collect information about the patient’s health condition, how the patient is being treated with nivolumab and if there are any side effects from the treatment, and how the side effects are managed by the patient’s doctor. This study involves the collecting of information only and will not affect the treatment decision made by the patient’s physician. The data will be collected from the information previously recorded by the patient’s physician in the medical records, and future data that is collected by the patient’s doctor as part of routine care and treatment until the patient completes the study or withdraws consent. Participation in this study, the collected information and study results will help to understand how nivolumab is used and how best its side effects can be managed.

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Inclusion Criteria

Individuals must meet all of the following inclusion criteria to be eligible for the study:

  • Age >= 18
  • Histologically or cytologically confirmed diagnosis of melanoma (including uveal
    melanoma) or lung cancer
  • Treatment with commercial nivolumab for the first time, alone or in combination with ipilimumab, for the approved indications of nivolumab within 14 days before informed consent for this study OR in the case where treatment has not yet been initiated, documentation that the treatment strategy is determined before an informed consent to study participation, and treatment is initiated within 28 days after informed consent.

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Exclusion Criteria

Individuals will not be enrolled if 1 of the following exclusion criteria is met:

  • Prior participation in a clinical trial within the past 4 weeks.
  • Previously treated with anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies.
  • Previously treated with anti-CTLA-4 for lung cancer.
  • Current or pending participation in a clinical trial.
  • Current or pending systemic treatment for cancer other than melanoma and lung cancer.
  • Inability to comply with the study protocol.

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ECOG 4512

A Randomized Phase III Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

Physician & Study Coordinator

Study Coordinator

Vanessa Shaw, BS, RN
484-526-6038

Vanessa.Shaw@sluhn.org

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Synopsis

Treatment Agent: Crizotinib

Synopsis: The purpose of this research study is to compare any good and bad effects of using the study drug, crizotinib (also known as XALKORI®), after completion of surgery and, in some cases, after chemotherapy and/or radiation therapy for ALK-positive non-small cell lung cancer. The addition of crizotinib may help prevent your cancer from returning, but it could also cause side effects. This research study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the study drug should improve how long you are able to live by 2 years and 9 months (33 months total) or more compared to the usual approach. The study drug, crizotinib, is already FDA-approved for use in ALK-positive locally advanced or metastatic (spread to other areas of the body) non-small lung cancer. The use of crizotinib in this study is investigational (not approved by the FDA) because crizotinib (or placebo) will be prescribed for earlier stage disease after the cancer has been surgically removed. A placebo is a capsule that looks like the study drug but contains no medication.

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Inclusion Criteria
  • Patients must have undergone complete surgical resection of their stage IB (>= 4 cm), II, or IIIA NSCLC per American Joint Committee on Cancer (AJCC) 7th edition and have had negative margins; N3 disease is not allowed
  • Baseline chest computed tomography (CT) must be performed within 3 months (90 days) prior to randomization to ensure no evidence of disease; if clinically indicated additional imaging studies must be performed to rule out metastatic disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A151216) trial prior to randomization
  • Positive for translocation or inversion events involving the ALK gene locus (e.g. resulting in echinoderm microtubule associated protein like 4 [EML4]-ALK fusion) as determined by the Vysis Break Point fluorescence in situ hybridization (FISH) assay and defined by an increase in the distance between 5' and 3' ALK probes or the loss of the 5' probe; this must have been performed:
    • By a local Clinical Laboratory Improvement Amendments (CLIA) certified laboratory: Report must indicate the results as well as the CLIA number of the laboratory which performed the assay; tissue must be available for submission for central, retrospective confirmation of the ALK fusion status via ALCHEMIST-SCREEN (ALLIANCE A151216) OR
    • Patient registered to and the ALK fusion status performed centrally on the ALCHEMIST-SCREEN (ALLIANCE A151216)
  • Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood or urine pregnancy test within 72 hours prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • Women of childbearing potential and sexually active males must be strongly advised to practice abstinence or use an accepted and effective method of contraception
  • Patients must NOT have uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • No known interstitial fibrosis or interstitial lung disease
  • No prior treatment with crizotinib or another ALK inhibitor
  • No ongoing cardiac dysrhythmias of grade >= 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, uncontrolled atrial fibrillation (any grade), or corrected QT (QTc) interval > 470 msec
  • No use of medications, herbals, or foods that are known potent cytochrome P450, subfamily 3A, polypeptide 4 (CYP3A4) inhibitors or inducers, included but not limited to those outlined
  • Patients must be adequately recovered from surgery at the time of randomization
  • The minimum time requirement between date of surgery and randomization must be at least 4 weeks (28 days)
  • The maximum time requirement between surgery and randomization must be:
    • 3 months (90 days) if no adjuvant chemotherapy was administered
    • 6 months (180 days) if adjuvant chemotherapy was administered
    • 8 months (240 days) if adjuvant chemotherapy and radiation therapy were administered
  • Patients must have completed any prior chemotherapy or radiation therapy 2 or more weeks (6 or more weeks for mitomycin and nitrosoureas) prior to randomization and be adequately recovered at the time of randomization NOTE: Patients taking low dose methotrexate for non-malignant conditions and other cytotoxic agents for non-malignant conditions are allowed to continue treatment while on study
  • Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) =< 2.5="" x="" upper="" limit="" of="" normal="" />
  • Total serum bilirubin =< 1.5="" x="" />
  • Absolute neutrophil count (ANC) >= 1500/mm^3
  • Platelets >= 30,000/mm^3
  • Hemoglobin >= 8.0 g/dL
  • Serum creatinine =< 2="" x="" />
  • Prior to randomization patients with any non-hematologic toxicity from surgery, chemotherapy, or radiation must have recovered to grade =< 1="" with="" the="" exception="" of="" alopecia="" and="" the="" criteria="" />
  • Patients must not have any history of cancer within 2 years from randomization, with the exception of in-situ carcinoma of the cervix or completely resected non-melanoma skin cancer
  • Patients may not be receiving any other investigational agents while on study

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ECOG-ACRIN 5142

Adjuvant Nivolumab in Resected Lung Cancers (ANVIL)-A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers 

Physician & Study Coordinator

Study Coordinator

Vanessa Shaw, BS, RN
484-526-6038

Vanessa.Shaw@sluhn.org

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Synopsis

Treatment Agent: Nivolumab

Synopsis: The purpose of this study is to find if adding the study drug, nivolumab (also known as OPVIDO®), will limit lung cancer from growing back in patients with early stage non-small cell lung cancer. Nivolumab is a drug that may turn on the body’s immune system to attack any cancer cells that may remain after surgery. The addition of nivolumab may help prevent your cancer from returning, but it could also cause side effects. This research study will allow researchers to find out whether this different treatment is better, the same, or worse than the usual treatment for lung cancer. The study drug, nivolumab, is already FDA-approved for use in non-small cell lung cancer that has previously been treated with chemotherapy. The use of nivolumab in this study is investigational (not approved by the FDA) in your type of cancer.

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Inclusion Criteria
  • Patients must have undergone complete surgical resection of their stage IB (>= 4 cm), II or IIIA NSCLC according to the American Joint Committee on Cancer (AJCC) 7th edition and have had negative surgical margins
  • Baseline chest computed tomography (CT) must be performed within 1 month (30 days) of randomization to ensure no evidence of disease; if clinically indicated, additional imaging studies must be performed to rule out metastatic disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A151216) trial prior to randomization
  • Non-squamous tumors must be epidermal growth factor receptor (EGFR) and anaplastic lymphoma receptor tyrosine kinase (ALK) wild-type (results ascertained in centrally as part of ALCHEMIST-SCREEN protocol)
  • Tumors must have PD-L1 status tested centrally as part of the ALCHEMIST-SCREEN protocol
  • Women must not be pregnant or breast-feeding
  • All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse during the treatment period and for 31 weeks after the last nivolumab infusion
  • Patients must NOT have uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
  • No prior treatment with an immune checkpoint inhibitor (anti-programmed cell death [PD]-1, anti-PD-L1, anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA4] monoclonal antibody)
  • Patients must have adequately recovered from surgery and chemotherapy at the time of randomization
    • Minimum time between date of surgery and randomization is 4 weeks
    • Maximum time allowed between surgery and randomization:
      • 10 months if adjuvant chemotherapy and radiation therapy was administered
      • 8 months if adjuvant chemotherapy was administered
      • 3 months if no chemotherapy is administered
  • Patients must have completed and recovered from any adjuvant chemotherapy 2 or more weeks prior to randomization (6 weeks for mitomycin and nitrosoureas; 4 weeks for post-operative radiation therapy)
  • Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) =< 2.5 x upper limit normal
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) (except in subjects with Gilbert syndrome who must have a total bilirubin < 3.0 x ULN)
  • White blood cell (WBC) >= 2000/uL
  • Neutrophils >= 1000/uL
  • Platelets >= 100 x 10^3/uL
  • Hemoglobin >= 8 g/dL
  • Serum creatinine =< 2 x ULN
  • Prior to randomization patients with any non-hematologic toxicity from surgery, chemotherapy and radiation therapy must have recovered to grade =< 1 with the exception of alopecia, ototoxicity and neuropathy
  • Patients must not have any history of active malignancy within two years from randomization deemed by the investigator to pose a higher risk of recurrence than the lung cancer in question
  • Patients must not be receiving any other investigational anti-cancer agents while on study
  • Patients must not have known or suspected autoimmune disease; subjects with type I diabetes mellitus, hypothyroidism requiring hormone replacement, or skin disorders not requiring systemic treatment are permitted to enroll
  • Patients must not have a condition requiring systemic corticosteroids equivalent to > 10 mg prednisone per day or other immunosuppressive medications within 2 weeks of randomization
  • Patients must not have known interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
  • Patients must not have a known history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection that is untreated and/or with a detectable viral load
  • Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab

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