Microbiome in Lung Cancer and Other Malignancies

The Role of Microbiome in Lung Cancer and Other Malignancies

To characterize the fecal, skin, nasal and oral microbiome and metabolome in patients with lung cancer and other malignancies, and correlate to treatment response and toxicities of various therapies including immunotherapy, chemotherapy and targeted therapy, etc.

Study Overview

• Status: Completed
• Conditions: Cancer; Lung Cancer; Malignancy
• Intervention / Treatment: Procedure: Nasal Swab; Procedure: Oral Swab; Other: Stool Collection; Genetic: Microbiome analysis; Genetic: DNA Banking; Procedure: Skin Swab

Detailed Description

Patients will be asked to provide nasal, oral and skin swabs, as well as stool samples during their regular clinic visits, at the baseline before desired therapy is given, and at the time when treatment is changed due to either disease progression or unbearable toxicities leading to treatment stop/change. If treatment stop/held is due to toxicities, a 3rd set of samples will be collected when toxicities reduce to less than grade 1. The samples will be subjected to DNA extraction followed by 16S rRNA and/or shotgun sequencing metagenomic analysis. The data will be correlated to clinical response from treatments, toxicities, clinical data (use of antibiotics, PPIs, lab parameters, etc.) and tissue genetic/immunological characteristics (mutations, PDL1 expression, etc.) for review of response. This is not data to be used for treatment of these subjects.

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All individuals, meeting eligibility requirements will be eligible to participate in the study by providing samples during times of routine care for lung cancer and other malignancies.

Description

Inclusion Criteria:

Patients diagnosed with lung cancer and other malignancies who are candidates for systemic therapies such as immunotherapy and chemotherapy

Eligibility criteria for studying microbiome in patients receiving immunotherapy:

• Patients with advanced/recurrent lung cancer (including both NSCLC and SCLC) and other solid tumors of our study interest (e.g. GU cancer and melanoma, etc.) that initiate a new line of immunotherapy (can be 1st or later line), either alone or in combination with chemotherapy, targeted therapy or other immunotherapy.
• Patients can be in other clinical trials as long as they meet criteria 1.
• Prior treatment with immunotherapy is acceptable as long as criteria 1 is met. For example, a new line therapy with pembrolizumab plus pemetrexed after failing pembrolizumab is considered eligible.
• Patients who are to start immunotherapy maintenance after chemoradiation therapy are eligible (e.g. NSCLC patients who will be on durvalumab maintenance)
• Patients who are to start immunotherapy after local therapies (e.g. radiation, ablation, etc.) are eligible.
• Immunotherapy must have component of anti-PD-1/PD-L1 agents (e.g. nivolumab, pembrolizumab, atezolizumab, durvalumab and avelumab, etc.) or anti-CTLA4 (e.g. ipilimumab)

Exclusion Criteria:

• Patients < 18 years of age
• Patients that are pregnant
• Patients taking more than 2 alcoholic drinks per day and those using non-medical drugs such as marijuana, cocaine, heroine, etc.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify and compare bacteria within given samples through standard protocol and 16S rRNA amplicon	Bacterial DNA will be isolated from stool/swab samples using standard protocol. Fecal micobiota will be examined based on an 16S rRNA amplicon.	Time of study enrollment up to one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlate data from samples with patient clinical information	Correlate data from samples with patient clinical information regarding overall response rates.	Time of study enrollment up to one year
Number of treatment related adverse events (AE) as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	Record from each clinical visit the AEs from immunotherapy or its combination with chemotherapy.	Time of study enrollment up to one year

Collaborators and Investigators

• Sponsor: Taher Abu Hejleh
• Collaborators: Holden Comprehensive Cancer Center; Iowa Institute of Human Genetics

Publications and helpful links

General Publications

• Strouse C, Mangalam A, Zhang J. Bugs in the system: bringing the human microbiome to bear in cancer immunotherapy. Gut Microbes. 2019;10(2):109-112. doi: 10.1080/19490976.2018.1511665. Epub 2018 Sep 5.
• Swami U, Zakharia Y, Zhang J. Understanding Microbiome Effect on Immune Checkpoint Inhibition in Lung Cancer: Placing the Puzzle Pieces Together. J Immunother. 2018 Oct;41(8):359-360. doi: 10.1097/CJI.0000000000000232.
• Chau J, Yadav M, Liu B, Furqan M, Dai Q, Shahi S, Gupta A, Mercer KN, Eastman E, Hejleh TA, Chan C, Weiner GJ, Cherwin C, Lee STM, Zhong C, Mangalam A, Zhang J. Prospective correlation between the patient microbiome with response to and development of immune-mediated adverse effects to immunotherapy in lung cancer. BMC Cancer. 2021 Jul 13;21(1):808. doi: 10.1186/s12885-021-08530-z.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 30, 2018
• Primary Completion (ACTUAL): September 23, 2019
• Study Completion (ACTUAL): May 9, 2022

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: September 26, 2018
• First Posted (ACTUAL): September 28, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 201712819

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No