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Lung Cancer

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Lung Genomics

“Analysis of Gene Expression in Peripheral Blood Mononuclear Cells in Lung Cancer”

Study Objective: To explore the possibility of developing a blood test to help detect lung cancer. This study will analyze different genetic aspects of the blood collected to identify possible markers for lung cancer.

Principal Investigator: Robert Korst, M.D.


 

INCB 39110-207

An Open-Label Phase 1/2 Study of INCB039110 in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic Non–Small Cell Lung Cancer

Treatment: Osimertinib 80 mg QD + INCB039110 400 mg QD

Key Inclusion Criteria:
  • Stage IIIB/IV NSCLC EGFR with T790M mutation (requiring central confirmation from archival or fresh biopsy)
  • Progressed on 1st line EGFR TKI
  • ECOG 0-1
  • No active CNS mets
  • Measurable disease

Principal Investigator: Eli Kirshner, M.D.

Click here for more information on INCB 39110-207


 

I-ELCAP International Early Lung Cancer Action Program

Study Objective: Early lung cancer detection using low-dose computed tomography.

*Out of pocket screening cost of $300 for low-dose CT of the chest; open to patients that meet the following.

INCLUSION CRITERIA:

  • Age 55-77 with a cigarette smoking history of at least 30 pack-years [Pack-years = packs per day x number of years smoking]
  • Having one of the following risk factors: current smoker, or former smoker (must have quit within the past 15 years)
  • Ability to provide informed consent

EXCLUSION CRITERIA:

  • Pregnancy
  • Symptoms of lung cancer; for example, worsening cough, dyspnea, unexplained weight loss, hemoptysis or chest pain over the past 2 months
  • Chest CT performed within the past year
  • History of malignancy within the past year, except for basal or squamous cell carcinoma of the skin
  • Other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
     

Principal Investigator: Robert Korst, M.D.

Click here for more information on  I-ELCAP

 



ALCHEMIST Trials

The ALCHEMIST trials are a group of 3 trials (1 screning trial + 2 treatment trials).

Principal Investigator: Jason Suh, M.D.

 

A151216 – Screening

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

Study Objective: This research trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

No treatment. Confirm mutation to enroll in EGFR+ or ALK+ trial.
 

 

A081105 – EGFR + Treatment

“Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)”

 
Study Objective: This randomized phase III trial studies how well erlotinib hydrochloride compared to placebo works in treating patients with stage IB-IIIA non-small cell lung cancer that has been completely removed by surgery. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
 
  • Arm 1: Erlotnib
  • Arm 2: Placebo


E4512 – ALK + Treatment

“A Phase II Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein”
 
Study Objectives: This randomized phase III trial studies how well crizotinib works and compares it to placebo in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called ALK. Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Tumors with this mutation may respond to treatments that target the mutation, such as crizotinib. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. It is not yet known if crizotinib may be an effective treatment for treating non-small cell lung cancer with an ALK fusion mutation.
 
  • Arm 1: Crizotinib
  • Arm 2: Placebo

EA5142

“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 Cancer”
 
Study Objectives: This randomized phase III trial studies how well nivolumab after surgery and chemotherapy work in treating patients with Stage IB-IIIA non-small cell lung cancer. Monoclonal antibodies, such as nivolumab, may stimulate the immune system in different ways and kill tumor cells remaining after surgery and standard-of-care chemotherapy.
 
  • Arm 1: Following SOC adjuvant chemotherapy, patient will receive Nivolumab 240 mg IV q2 weeks for up to 1 year
  • Arm 2: Following SOC adjuvant chemotherapy, patient will be observed

 

Eligibility: 
 

  • Enrolled in ALCHEMIST Screening Trial (A151216); Stage IB (<4cm) to IIIA NSCLC, resected with negative margins
  • No EGFR or ALK mutations
  • ECOG 0-1

Click here for more information on E5142


 

CALGB 30610

“Phase III Comparison of Thoracic Radiotherapy Regimens in Patients With Limited Small Cell Lung Cancer Also Receiving Cisplatin or Carboplatin and Etoposide"

Inclusion:

  • Small cell lung cancer, limited stage, with measurable disease
  • No prior chemo or radiation for SCLC (may have had up to 1 cycle or first-line chemo)
  • ECOG 0-2


Randomization (experimental portion in italics)

Arm A: 

  • Radiotherapy (every day, Monday-Friday, for a total of 3 weeks)
  • XRT: 45 Gy BID (1.5 Gy/fx) starting on day 1 of Cycle 1 or 2, every day for 3 weeks
  • Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks)
  • Cisplatin 80 mg/m2 IV on day 1 OR Carboplatin AUC 5 IV day 1, every 21 days
  • Etoposide 100 mg/m2 IV on days 1, 2 and 3, every 21 days


Arm B:

  • Radiotherapy (every day, Monday-Friday, for a total of 7 weeks)
  • XRT: 70 Gy QD (2.0 Gy/fx) starting on day 1 of Cycle 1 or 2, every day for 7 weeks
  • Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks)
  • Cisplatin 80 mg/m2 IV on day 1 OR Carboplatin AUC 5 IV day 1
  • Etoposide 100 mg/m2 IV on days 1, 2 and 3


Principal Investigator: Chad DeYoung, M.D.

Click here for more information on CALGB 30610



GO29527

“A Phase III, Open-label, Randomized Study to Investigate the Efficacy and Safety of MPDL3280A (Anti-PD-L1 Antibody) Compared With Best Supportive Care Following Adjuvant Cisplatin-based Chemotherapy in PD-L1-Selected Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer”

Study Objectives: To evaluate the efficacy of 16 cycles of Atezolizumab (MPDL3280A) treatment compared with best supportive care as measured by disease-free survival (DFS) as assessed by the investigator.

  • Arm A: Atezolizumab (MPDL3280A) 1200 mg will be administered intravenously (IV) every 3 weeks for 16 cycles
  • Arm B: Best Supportive Care (BSC)
Principal Investigator: Eli Kirshner, MD

 

Click here for more information on GO29527


 

Vision

“A Phase II, Single-Arm Trial to Investigate Tepotinib in Stage IIIB/IV Adenocarcinoma of the Lung With MET Exon 14 (METex14) Skipping Alterations After Failure of at Least One Prior Active Therapy, Including a Platinum-Doublet-Containing Regimen

Study Objective: This study will look at how effective the study drug (tepotinib) is at stopping the growth and spread of lung cancer that carries a specific genetic alteration (MET exon 14 skipping alterations) and that did not respond to standard of care treatment, such as chemotherapy (platinum doublet-containing regimen). This study will also measure a number of other things, including safety of the study drug and the side effects, how the body processes the study drug, or how the study drug affects your quality of life. The study also has an optional pharmacogenetic research part. Pharmacogenetic research is an important way to try to understand the role of genetics in human disease and how genes impact the effectiveness of drugs, because differences in genes can change the way a person responds to a particular drug.

Arm 1: Tepotinib

Principal Investigator: Eli Kirshner, MD

Click here for more information on Project Blue



IBV Valve System

“A Humanitarian Use Device intended to control prolonged air leaks / Humanitarian Device Exemption (HDE) H06002"

Principal Investigator: Robert Korst, M.D.



S1400 Lung Map

“A Biomarker-Driven Master Protocol for Previously Treated Squamous Lung Cancer (LUNG-MAP)”

Study Objectives: To establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi sub-study hybrid "Master Protocol" (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a "non-match" sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.

Inclusion:

  • Stage IV or recurrent squamous cell carcinoma
  • Tissue available for central testing

All patients are required to enroll in the screening portion of the study: S1400

Patients will then be enrolled into 1 of 4 treatment portions: S1400F, S1400I, S1400G or S1400K 


Principal Investigator: Jin Lee, M.D.

 



Checkmate816

A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC) (CheckMate 816)

Study Objectives: The purpose of this study is to determine the safety and effectiveness of nivolumab plus ipilimumab or nivolumab plus chemotherapy compared to chemotherapy alone in the treatment of Early Stage Non-Small Cell Lung Cancer.

  • Arm 1: Nivolumab plus Ipilimumab
  • Arm 2: Nivolumab plus platinum doublet chemotherapy  

Principal Investigator: Eli Kirshner, M.D.

Click here for more information on Checkmate816



EA5161

Randomized Phase II Clinical Trial of Cisplatin/Carboplatin and Etoposide (CE) alone or in Combination with Nivolumab as Frontline Therapy for Extensive Stage Small Cell Lung Cancer (ED-SCLC)

Treatment
  • Arm A: Experimental: Cisplatin/Carboplatin + Etoposide + Nivolumab --> Nivolumab maintenance
  • Arm B: SOC: Cisplatin/Carboplatin + Etoposide --> Observation

Eligibility
  • Extensive stage SCLC
  • ECOG 0-1
  • CNS mets must be adequately treated with no neurological symptoms
  • Prior chemo/radiation for limited stage SCLC must have been at least 6 months prior to current diagnosis

Principal Investigator: Eli Kirshner, MD

Click here for more information

 

CYPRESS 2

A Randomized Phase 2 Trial of AM0010 in Combination With Nivolumab vs. Nivolumab Alone as Second-Line Therapy in Subjects With Stage IV / Metastatic Wild Type Non-Small Cell Lung Cancer and Low Tumor Expression of PD-L1

Treatment Arms:
  • Nivolumab (240mg q2weeks, IV) + AM0010 (daily subcutaneous injection)
  • Nivolumab (240mg q2weeks, IV)

Inclusion summary:
  • Stage IV NSCLC, PD-L1 <50%, having progressed on 1st line treatment
  • ECOG 0-1
  • No prior treatment with immunotherapy

Principal Investigator: Eli Kirshner, MD

Click here for more information on CYPRESS 2

 

G1T38-03

Phase 1b/2 Safety, Pharmacokinetic, and Efficacy Study of G1T38 in Combination with Osimertinib in Patients with EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC)”

Treatment: Osimertinib 80mg + G1T38 (dose based on cohort currently enrolling)

Inclusion:
  • Confirmed Stage IV NSCLC with EGFR mutation
  • Prior treatment with up to 2 lines of therapy (including chemotherapy and TKI/tarceva)
  • Measurable disease per RECIST 1.1 ECOG 0-1
  • Considerable cardiovascular requirements

Principal Investigator: Eli Kirshner, MD

Click here for more information on G1T38-03 

 

The Valley Hospital Biorepository

For The Valley Hospital (TVH) patients undergoing surgical procedures, we offer the opportunity to participate in TVH Biorepository.  This protocol involves the freezing and storage of extra tissue not used for diagnosis, blood and other bodily fluids that may be used for future research designed to develop or contribute to generalized knowledge in cancer research. This is available to all patients diagnosed with cancer and having surgery for excision, and is strongly encouraged.

Genetic research is currently being done at Valley on lung cancer specimens with DNA arrays and proteomics.



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