NCT04636775

Microbiome in Immunotherapy naïve NSCLC Patients Receiving PD-1/L1 Blockade (MIP_NSCLC)

Status unknown Last updated 11 December 2023

What this trial tests

trial testing Microbiome in NSCLC Stage IV in 46 participants. Status unknown.

Timeline

29 July 2020

Primary endpoint
30 August 2024

31 December 2024

Quick facts

Lead sponsor	Jun Zhang, MD, PhD
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	46
Start date	29 July 2020
Primary completion	30 August 2024
Estimated completion	31 December 2024
Sites	3 locations across United States

Drugs / interventions tested

• Microbiome

Conditions studied

• NSCLC Stage IV — all drugs for NSCLC Stage IV →
• NSCLC, Recurrent — all drugs for NSCLC, Recurrent →

Sponsor

Jun Zhang, MD, PhD — full company profile →

Who can join

18 and older, any sex, with NSCLC Stage IV or NSCLC, Recurrent. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase IV study is hoping to determine if examining the microbiome in non-small cell lung cancer, immunotherapy naive participants can predict the effectiveness of immunotherapy treatment as well as determine ahead of time adverse events and their severity. In addition, the investigator will look into microbiome changing modifiers.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Prospective correlation between the patient microbiome with response to and development of immune-mediated adverse effects to immunotherapy in lung cancer.
   Chau J, Yadav M, Liu B, Furqan M, et al · · 2021 · cited 54× · PMID 34256732 · DOI 10.1186/s12885-021-08530-z
2. The Role of the Gut Microbiome in Cancer Immunotherapy: Current Knowledge and Future Directions.
   Kiousi DE, Kouroutzidou AZ, Neanidis K, Karavanis E, et al · · 2023 · cited 29× · PMID 37046762 · DOI 10.3390/cancers15072101
3. Novel insights on gut microbiota manipulation and immune checkpoint inhibition in cancer (Review).
   Vivarelli S, Falzone L, Leonardi GC, Salmeri M, et al · · 2021 · cited 21× · PMID 34396439 · DOI 10.3892/ijo.2021.5255
4. Prognostic and Predictive Biomarkers in Non-Small Cell Lung Cancer Patients on Immunotherapy-The Role of Liquid Biopsy in Unraveling the Puzzle.
   Augustus E, Zwaenepoel K, Siozopoulou V, Raskin J, et al · · 2021 · cited 21× · PMID 33918147 · DOI 10.3390/cancers13071675
5. Exploring Gut Microbiome in Predicting the Efficacy of Immunotherapy in Non-Small Cell Lung Cancer.
   Liu B, Chau J, Dai Q, Zhong C, et al · · 2022 · cited 18× · PMID 36358819 · DOI 10.3390/cancers14215401
6. Exploring the Role of the Gut and Intratumoral Microbiomes in Tumor Progression and Metastasis.
   Sevcikova A, Mladosievicova B, Mego M, Ciernikova S. · · 2023 · cited 17× · PMID 38139030 · DOI 10.3390/ijms242417199
7. Monitoring and Modulating Diet and Gut Microbes to Enhance Response and Reduce Toxicity to Cancer Treatment.
   Knisely A, Seo YD, Wargo JA, Chelvanambi M. · · 2023 · cited 14× · PMID 36765735 · DOI 10.3390/cancers15030777
8. A new biological triangle in cancer: intestinal microbiota, immune checkpoint inhibitors and antibiotics.
   Zhang J, Dai Z, Yan C, Zhang W, et al · · 2021 · cited 14× · PMID 34125407 · DOI 10.1007/s12094-021-02659-w