Clinical trial NCT03688347: Microbiome in Lung Cancer and Other Malignancies
Official title: The Role of Microbiome in Lung Cancer and Other Malignancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Cancer
Malignancy
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Holden Comprehensive Cancer Center
name: Iowa Institute of Human Genetics
First posted: 2018-09-28
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Identify and compare bacteria within given samples through standard protocol and 16S rRNA amplicon
timeFrame: Time of study enrollment up to one year
Secondary outcomes:
measure: Correlate data from samples with patient clinical information
timeFrame: Time of study enrollment up to one year
measure: Number of treatment related adverse events (AE) as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
timeFrame: Time of study enrollment up to one year
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Taher Abu Hejleh, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.