lung cancer Metastasized or locally advanced non-small cell lung cancer (NSCLC)
Conditions
Interventions
Lyophilized fecal microbiota capsules (LFMC), that are produced from the feces
of healthy obese donors. At 0 and 3 weeks, participants ingest 10 capsules as
loading dose, followed by 1 capsule per d
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Male or female. - Age >=18 years. - Diagnosed with NSCLC of any histology, receiving standard first-line immunotherapy w/wo chemotherapy according to local practice (see 5.2). - Stable disease (according to RECIST) as best overall response after at least 2 cycles of prior treatment. - ECOG performance status 0-2. - Able to understand the information and give informed consent.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Contraindication to continue immunotherapy w/wo chemotherapy. - Unable to comply with study procedures. - Unable to ingest size 00 capsules (size of the LFMC). - Any condition which, in the investigator*s opinion, might jeopardize participants* safety or compliance with the protocol. - Participation in another concomitant clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the ORR as measured by RECIST criteria measured 6 and 12 weeks after initiation of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include duration of response, progression-free survival (PFS) and overall survival (OS); safety, measured as adverse events (AE); and changes in gut microbiota composition after 3, 6 and 12 weeks. | — |
Countries
Netherlands
Outcome results
None listed