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Lung/Thoracic Cancer Trials

The Establishment and Maintenance of a Comprehensive Thoracic Tumor Data Registry and Bioreceptor 
Aims: The purpose of this database is to allow researchers to review and compare medical information including medical history, symptoms, medical test results, treatments and complications that people with thoracic tumor may have. Another purpose of this study is to collect leftover tissue obtained during thoracic surgery or diagnostic tests. Research testing of this tissue may help to determine the changes which lead to the development and/or spread of cancer. This information may help to develop new kinds of diagnostic tests and treatment for thoracic cancer.
Diagnosis: Thoracic Cancer
Principal Investigator: Thomas Hensing, MD
IRB Approval Number: EH98-136
Sponsor: NorthShore University HealthSystem
Contact: Interested patients should contact research coordinator Kanwal Zeeshan at 847.570.1697
Open to Enrollment: Yes

LungMAP: A Master Protocol to Evaluate Biomarker-Driven Therapies and Immunotherapies in Previously Treated Non-
Small Cell Lung Cancer

Aims: The purpose of this study screening step is to perform genetic tests on your tumor sample for certain features that investigational targeted agents used in this study are specifically designed to work against. Then the purpose is to assign you to a treatment sub-study that is chosen based on the results (genes and proteins called "biomarkers") of this genetic testing on your tumor sample. This study related "research test" will be done in a special lab. The system of assigning a treatment sub-study based on genetic testing of cancer is investigational; in squamous cell lung cancer patients, we don’t know whether testing can identify patients who will or will not benefit from treatment.
Diagnosis: Non-Small Cell Lung Cancer
Principal Investigator: Thomas Hensing, MD
IRB Approval Number: EH19-106
Sponsor: Southwest Oncology Group
Contact: Interested patients should contact research nurse Michele Britto, RN at 847.570.2109
Open to Enrollment: Yes

E4512: Testing the Addition of Drug Crizotinib After Surgery to Remove ALK-Positive Non-Small Cell Lung Cancer: A Phase III 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
Aims: The purpose of this research study is to compare any good and bad effects of using the study drug, crizotinib (also known as XALKORI(R)), after completion of surgery and, in some cases, after chemotherapy and/or radiation therapy for ALK-positive non-small cell lung cancer. In 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.
Diagnosis: Non-Small Cell Lung Cancer
Principal Investigator: Thomas Hensing, MD
IRB Approval Number: EH15-121
Sponsor: ECOG-ACRIN
Contact: Interested patients should contact Michele Britto at 847.570.2109
Open to Enrollment: Yes

A151216: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)
Aims: The purpose of this research study is to determine if patients with Non-Small Cell Lung Cancer (NSCLC) have a mutation (abnormal change) in the DNA or their tumor and if so, which one.  The genetic mutations which are being assessed are: EGFR, ALK, an dPD-L1.  Not all lung tumors have changes in genes.  The study will lead into two optional treatment trials which will use specific drugs to target these genes as well as tumors without mutations.  Tissue from the tumor removed at the time of surgery is sent to a national laboratory to be analyzed and compared to local results. 
Diagnosis: Non-Small Cell Lung Cancer (NSCLC) Stage IB, II, IIIA
Principal Investigator: Thomas Hensing, MD
IRB Approval Number: EH15-122
Sponsor: Alliance
Contact: Interested patients should contact Michele Britto at 847.570.2109
Open to Enrollment: Yes

A081105: 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)
Aims: The purpose of this research 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 against patients who are treated with the standard treatment plus erlotinib (and investigational drug).
Diagnosis: Non-Small Cell Lung Cancer (NSCLC)
Principal Investigator: Thomas Hensing, MD 
IRB Approval Number: EH15-123
Sponsor: Alliance
Contact: Interested patients should contact Michele Britto at 847.570.2109
Open to Enrollment: Yes

Best Practice in VATS Lobectomy and Segmentectomy for Lung Cancer: A Prospective, Observational, Quality Improvement Study to Optimize Care for Lung Cancer Patients Undergoing Video-Assisted Thoracoscopic Surgery (VATS)
Aims: This is a multi-center study which will be conducted at seven sites. The purpose of this study is to establish a database for doing data and cost analysis of the workup, early treatment and follow-up of patients who have VATS lobectomy or segmentectomy for lung cancer.
Diagnosis: Lung Cancer
Principal Investigator: Seth Krantz, MD
IRB Approval Number: EH13-155
Sponsor: Ethicon Endo Surgery
Contact: Interested participants may contact Kanwal Zeesha, MBBS, CCRP at 847.570.1697, kzeesha@northshore.org
Open to Enrollment
: Yes 

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 Cancers
Aims:
The purpose of this research study is to find out whether treatment with nivolumab (also known as OPDIVO), a type of immunotherapy will result in improved survival over placebo for patients with STage IB-IIIA NSCLC following complete resection and standard post-operative therapy.  This study is the treatment trial linked to A151216 Alchemist trial withere the tissue is sent for determination of gene mutations post operatively.
Diagnosis: Non-Small Cell Lung Cancer (NSCLC) Stages IB, II, IIIA
Principal Investigator: Thomas Hensing, MD
IRB Approval Number: EH16-268
Sponsor: Alliance
Contact: Interested patients should contact Michele Britto at 847.570.2109
Open to Enrollment: Yes

Merck 3475-789: A Randomized, Double-Blind Phase 3 Study of Pemetrexed + Platinum Chemotherapy with or without Pembrolizumab (MK-3475) in TKI-Resistance EGFR-Mutated Patients in Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Participants (KEYNOTE-789)
Aims: The purpose of this research study is to see whether the adding the investigational drug, pembrolizumab, when given with chemotherapy after progression on TKI class of drugs has benefit for non-small- cell lung cancer
Principal Investigator: Nicholas Campbell, MD
IRB Approval Number: EH19-196
Sponsor: AbbVie Inc.
Contact: Interested patients should contact research nurse Michele Britto, RN at 847.570.2109
Open to Enrollment: Yes

 Merck 3475-799:  A Phase 2 Trial of Pembrolizumab (MK-3475) in Combination with Platinum Doublet Chemotherapy and Radiotherapy for Participants with Unresctable, Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC) (KEYNOTE-799)
Aims: The purpose of this research study is to see whether the adding the investigational drug, pembrolizumab, when given with chemotherapy and radiation therapy will be more beneficial than chemotherapy and radiation therapy alone.
Principal Investigator: Nicholas Campbell, MD
IRB Approval Number: EH18-342
Sponsor: AbbVie Inc.
Contact: Interested patients should contact research nurse Michele Britto, RN at 847.570.2109
Open to Enrollment: Yes

S1900A: A Phase II Study for Rucaparib in Patients with Genomic LOH High And/Or Deleterious BRCA 1/2 Mutation Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)
Aims: The purpose of this research study is to see whether the investigational drug, Rucaparib will shrink your tumor and keep it from growing. 
Diagnosis: Non-Small Cell Lung Cancer
Principal Investigator: Thomas Hensing, MD
IRB Approval Number: EH19-177
Sponsor: SWOG
Contact: Interested patients should contact research nurse Michele Britto, RN at 847.570.2109
Open to Enrollment: Yes

EA5163: A Randomized Phase III Study of Firstline Immunotherapy alone on in Combination with Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) iwth Immunobiomarker SIGNature-driven Analysis
Aims:  The purpose of this research study is see if starting treatment with immunotherapy instead of chemotherapy and immunotherapy together is better.
Diagnosis: Non-Small Cell Lung Cancer
Principal Investigator: Nicholas Campbell, MD
IRB Approval Number: EH19-224
Sponsor: ECOG-ACRIN
Contact: Interested patients should contact research nurse Michele Britto, RN at 847.570.2109
Open to Enrollment: 
Yes

AstraZeneca D5161C00003: A Multicenter, Open-Label, Single-Arm, Molecular Profiling Study of Patients with EGFR Mutation-Positive Locally Advanced or Metastatic NSCLC Treated with Osimertinib (ELIOS)
Aims: The purpose of this study is to test osimertinib to see if it works as first line treatment in delaying mutations in the EGFR gene.
Diagnosis: Non-small Cell Lung Cancer
Principal Investigator: Nicholas Campbell, MD
IRB Approval Number: EH18-272
Sponsor: AstraZeneca
Contact: Interested patients should contact research nurse Michele Britto, RN at 847.570.2109
Open to Enrollment: Yes (BUT ONLY AT EVANSTON HOSPITAL)

AbbVie M16-298 : A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)
Aims: The purpose of this research study is to see whether the investigational drug, rovalpituzumab tesirine, when given after standard chemotherapy, will help small- cell lung cancer from either coming back or getting worse.
Diagnosis: Small Cell Lung Cancer
Principal Investigator: Nicholas Campbell, MD
IRB Approval Number: EH17-103
Sponsor: AbbVie Inc.
Contact: Interested patients should contact research nurse Michele Britto, RN at 847.570.2109
Open to Enrollment: Yes