NIPH Clinical Trials Search

JRCT ID: jRCTs071220105

Registered date:10/02/2023


Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiednon-small Cell Lung Cancer
Date of first enrollment15/05/2023
Target sample size60
Countries of recruitment
Study typeInterventional
Intervention(s)Monotherapy: pembrolizumab + synbiotics* Non-squamous cell carcinoma: (Induction therapy: 4 courses) Pembrolizumab + pemetrexed + cisplatin or carboplatin + synbiotics* (maintenance therapy) pembrolizumab + pemetrexed + synbiotics* Squamous cell carcinoma: (Induction therapy: 4 courses) Pembrolizumab + paclitaxel or nab-paclitaxel + carboplatin + synbiotics* (maintenance therapy) Pembrolizumab + synbiotics* *take 3 times a day for 52 weeks


Primary OutcomeGut microbiome change index Change in bifidobacteria count from baseline to 24 +-4 weeks from the start date of cancer immune combination therapy
Secondary OutcomeGut microbiome change index Bifidobacteria count Composition of intestinal bacteria, alpha diversity, number of bacteria, pH, organic acid concentration Immuno-nutritional index prognostic nutritional index controlling nutritional risk score geriatric nutritional risk index Diversity of T cell antigen receptors in peripheral blood (TCR repertoire) Anti-tumor efficacy endpoints Response rate, disease control rate Progression-free survival Safety endpoints Adverse event rate

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteria1) Patients with histologically or cytologically diagnosed Stage IV (T any, N any, M1a or M1b or M1c (UICC 8th)) non-small cell lung cancer or postoperative recurrence not eligible for radical therapy. PD-L1 protein expression and histology (squamous or non-squamous) are not required. 2) Patients not eligible for epidermal growth factor receptor (EGFR) inhibitors, anaplastic lymphoma kinase (ALK) inhibitors, or c-ros oncogene (ROS1) inhibitors. 3) Patients scheduled to receive either pembrolizumab monotherapy or the following pembrolizumab combination therapy Pembrolizumab monotherapy: PD-L1 positive (Tumor Proportion Score (TPS)>= 50% (strongly positive)) Pembrolizumab + pemetrexed + cisplatin/ carboplatin: non-squamous non-small cell lung cancer Pembrolizumab + nab-Paclitaxel/paclitaxel + carboplatin: Squamous cell non-small cell lung cancer 4) Patients with at least one measurable lesion based on RECIST version 1.1 on imaging test within 28 days prior to enrollment. However, bone lesions, cystic lesions, and lesions with a history of topical treatment such as radiotherapy are considered as non-measurable lesions. 5) Patients untreated with chemotherapy including molecular-targeted drugs and cancer immunotherapy. However, a history of preoperative/postoperative adjuvant therapy is acceptable if completed at least 6 months prior to the date of enrollment. 6) Patients deemed able to cooperate in the collection and submission of fecal specimens and recording of patient diaries. 7) Patients who can orally ingest synbiotic foods (synprotec or placebo food). 8) Patients who are at least 20 years of age at the time of consent 9) Patients expected to survive more than 3 months 10) Patients with ECOG Performance Status 0 or 1 11) Patients who meet the following criteria for major organ function within 14 days prior to enrollment (based on the date of enrollment, the same day of prior two weeks is acceptable). If there are multiple test results within the period, the latest one will be used. Test item Reference value Neutrophil count >=1,500/mm3 Platelet count >=100,000 / mm3 Hemoglobin >=9.0 g/dL or >=5.6 mmol/L (after 4 weeks of transfusion) AST/ALT =<2.5 x ULN (if liver metastases present=<5.0 x ULN) Total bilirubin =<1.5 x ULN Creatinine =<1.5 x ULN If creatinine >1.5 x ULN, if creatinine clearance >= 60 mL/min 12) Patients who have been fully informed of the contents of this study and have given their written consent.
Exclude criteria1) Patients who are taking medicines containing prebiotics and probiotics on a daily basis, or taking supplements (including synprotec) at the time of informed consent. 2) Patients who are allergic to galactooligosaccharides or milk. 3) Patients with active infection of HIV, HBV, HCV, or syphilis. However, the following are acceptable for enrollment HBV: Patients who are HBs antibody-positive, HBc antibody-positive, or HBs antigen-positive, but whose viral load is less than sensitivity and who have inactive hepatitis may be enrolled. HCV: Antibody-positive patients with inactive hepatitis may be enrolled.4) Patients participating in other clinical trials or clinical studies. 5) Patients who have received radiation therapy to the lungs exceeding 30 Gy within 4 weeks of the date of consent. 6) Patients who completed palliative radiation therapy within 7 days prior to enrollment in this study. 7) Patients who have received a live vaccine within 30 days prior to enrollment in this study. 8) Patients with clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or carcinomatosis. 9) Patients with a history of malignancy other than non-small cell lung cancer, except for those who have been relapse-free for 5 years after the start of curative treatment. 10) Patients with active central nervous system (CNS) metastases or cancerous meningitis. However, patients who are asymptomatic and clinically stable may be enrolled. 11) Patients with a history of severe hypersensitivity reactions to other monoclonal antibodies. 12) Patients with hypersensitivity to cisplatin, carboplatin, pemetrexed, nab-paclitaxel and paclitaxel. 13) Patients with Grade >=2 peripheral neuropathy according to CTCAE version 5.0. 14) Patients with active autoimmune disease requiring systemic treatment within the past 2 years. 15) Patients chronically taking systemic steroids. 16) Patients with psychiatric, dementia, or substance abuse disorders that have been determined to have the potential to affect their participation in this study. 17) Patients with ascites or pleural effusions requiring treatment. However, patients who are clinically stable with treatment may be eligible for enrollment. 18) Patients with complication of interstitial lung disease or a history of pnemonitis requiring oral/intravenous corticosteroid therapy. 19) Pregnant patients, lactating patients, or patients who wish to have their own or their partner pregnancy during the period of this study. 20) Other patients who are judged by the principal investigator or sub-investigator to be inappropriate to participate in this study.

Related Information


Public contact
Name Fumihiro Shoji
Address 3-1-1 Minami-ku, Fukuoka 811-1395, Japan Fukuoka Japan 811-1395
Telephone +81-92-541-3231
Affiliation National Hospital Organization Kyushu Cancer Center
Scientific contact
Name Fumihiro Shoji
Address 3-1-1 Minami-ku, Fukuoka 811-1395, Japan Fukuoka Japan 811-1395
Telephone +81-92-541-3231
Affiliation National Hospital Organization Kyushu Cancer Center