A Randomized Double Blind Phase II Trial of Restorative Microbiota Therapy (RMT) in Combination With Durvalumab (MEDI4736) and Chemotherapy in Untreated Patients With Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer

Summary

This is a randomized, active-controlled, parallel-group, double-blind Phase II trial, of oral restorative microbiota therapy (RMT) or placebo combined with intravenous (IV) durvalumab (MEDI4736) plus chemotherapy in patients with treatment naïve advanced or metastatic adenocarcinoma non-small cell lung cancer (NSCLC)

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Oral Restorative Microbiota Therapy (RMT) Capsules

  Patients with PD-L1 TC expression will receive sixteen doses of oral RMT capsules weekly

• Drug
  Durvalumab 1500 mg IV

  Patients with PD-L1 TC expression receive durvalumab 1500 mg IV every 4 weeks (Q4W) until disease progression or for a maximum of two years from the 1st dose of durvalumab

• Drug
  Cisplatin/pemetrexed or Carboplatin/pemetrexed

  Patients with PD-L1 TC receive cisplatin/pemetrexed or carboplatin/pemetrexed given every 3 weeks (Q3W) for 4 cycles followed by pemetrexed maintenance given Q3W

• Other
  Placebo

  Sixteen doses of oral placebo capsules given weekly

Locations (10)