Phase II Study of Oral Restorative Microbiota Therapy with Durvalumab and Chemotherapy in Untreated Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating oral restorative microbiota therapy RMT combined with intravenous durvalumab and chemotherapy in patients with untreated advanced or metastatic adenocarcinoma non-small cell lung cancer NSCLC. This randomized, double-blind Phase II trial aims to assess the safety, tolerability, and effectiveness of this combination treatment compared to placebo. The study includes a safety run-in phase followed by randomization if no new safety issues arise. Participants receive sixteen weekly doses of oral RMT capsules or matching placebo. All patients also receive durvalumab 1500 mg intravenously every 4 weeks for up to two years or until disease progression. Chemotherapy with cisplatinpemetrexed or carboplatinpemetrexed is administered every 3 weeks for four cycles, followed by maintenance pemetrexed every 3 weeks. The initial safety run-in involves 10 patients treated with RMT over 4 weeks before further enrollment. During the study, patients are monitored for progression-free survival over three years and safety for two years. Researchers also assess tumor response, duration of response, overall survival, immune-related adverse events, and quality of life at regular intervals up to two or three years. Participants undergo regular clinical evaluations and laboratory testing to track treatment effects and safety throughout the trial.

RMT in Combination With Durvalumab + Chemo in Untreated Adenocarcinoma NSCLC. A Randomized Double Blind Phase II Trial