Microbiota Transplant in Advanced Lung Cancer Treated With Immunotherapy

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The gut microbiota can modulate the effectiveness of cancer therapies, especially immunotherapy. Manipulating the microbial populations in patients with advanced lung cancer through fecal microbiota transplantation from healthy individuals or from long-term survivors to advanced lung cancer will enhance the efficacy of immunotherapy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Treatments: Antibodies, Monoclonal; Atezolizumab; Pembrolizumab

Criteria

Inclusion Criteria:

• • Willing to sign the informed consent

• Age >18 years.

• Diagnosis of phase IV unresectable non-small cell cancer histologically or citologically confirmed.

• Eastern Cooperative Oncology Group (ECOG) Score ≤1

• Disease able to be monitored using the RECIST v.1.1. criteria (lesions treated with radiotherapy can be defined as target lesions if the progression has been documented).

• At least 3 weeks since the last treatment for cancer, including radiotherapy, and recovery ≤1 from any adverse event related with previous treatment for cancer, excluding sensorial neuropathy, anemia, asthenia, hair loss, all grade ≤2), according to the National Cancer Institute (CTCAE del NCI, v.5) definitions

• Adequate bone marrow, renal, liver and metabolic parameters (evaluated at least 7 days prior the inclusion in the study:

• Platelet count ≥100 x 109/l, hemoglobin ≥9 g/dl and absolute neutrophil count ≥1,000 x 109/l.

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 times the upper limit of normality, independently of the presence of liver metastases.

• Alkaline phosphatase ≤ 2,5 times the upper limit of normality.

• Total bilirubin ≤1,5 times the upper limit of normality o direct bilirubin below the upper level of normality.

• INR<1,5, except if concomitant oral anticoagulation

• Estimated glomerular filtration rate ≥30 ml/minute using the EPI equation

• Albumin ≥3 g/dl without previous parenteral albumin treatment. • All men and women with childbearing potential must accept the use of highly efficacious contraceptive methods during the study.

Exclusion Criteria:

• • Combination of standard chemotherapy + immunotherapy indicated

• Active of untreated central nervous system (CNS) involvement. Treated CNS metastases must be radiologically stable (defined as the absence of CNS progression during at least 3 weeks from the first CNS imaging after radiotherapy to the CNS imaging prior the screening visit. Participants will not be included in the presence of any neurological sign or symptom secondary to CNS metastases or radiotherapy. Any treatment with steroids must have been completed at least 14 days before the first study intervention.

• Prior use of immunotherapy of immunomodulatory treatment for non-small cell lung cancer, either in combination or in monotherapy, at any stage of the disease.

• Radiotherapy in >35% the bone marrow.

• Prior bone marrow or cell-stem transplant.

• Treatment with immunoestimulatory agents, including interferons or interleukin-2 before 4 weeks or 5 drug half-lives (whichever longer) before the randomization.

• Prior neoplasia, with the exception of skin basocelular carcinoma, superficial bladder carcinoma, squamous cell skin carcinoma, cervix high degree intrasquamous lesion. Those patients with prior neoplasia free of recurrence during at least 2 years are eligible.

• Severe infections four weeks before the screening, including hospitalization due to any infection, bacteremia or severe pneumonia.

• Rectal colonization by vancomycin resistant enterococci

• Overt immunodeficiency, including systemic treatment with steroids at >10 mg of prednisone/day (or its equivalent) or other immunosuppressive agents during the 14 days before the first study intervention.

• Mucositis, GI symptoms

• Dysphagia, history of aspirative pneumonia