Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Adenocarcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Adenocarcinoma of Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Lung Adenocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Carboplatin

Pemetrexed

Cisplatin

Durvalumab

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Antineoplastic Agents, Immunological

Folinic Acid

Folate

Vitamin B9

10 patients are enrolled in this safety run-in arm. Patients are directly assigned to RMT treatment arm. After safety- run-in period of 4 weeks after the first dose of RMT, in the 10 patients if no new safety signal are seen enrollment moves to randomization

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

Oral Restorative Microbiota Therapy (RMT) Capsules

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

Durvalumab 1500 mg IV

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

Cisplatin/pemetrexed or Carboplatin/pemetrexed

Sixteen doses of oral placebo capsules given weekly

Placebo

Cancer Center Clinical Trials Office

Amit Kulkarni, MBBS

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)

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

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

Incidence of PFS using RECIST 1.1 in each treatment arm to evaluate the efficacy of restorative microbiota therapy

Safety and tolerability of RMT in combination with durvalumab or durvalumab + chemotherapy as assessed by the incidence of adverse events

ORR of treatment with RMT in each treatment arm per RECIST 1.1

DOR of treatment with RMT in each treatment arm per RECIST 1.1

Incidence of OS using RECIST 1.1 in each treatment arm

Rate of immune mediated adverse events (imAE) in each treatment arm

ORR using immune response evaluation criteria in solid tumors (iRECIST)

Difference in health-related quality of life (QoL) using European organization for research and treatment of cancer quality of life questionnaire (EORTC QLQ-30)

Difference in health-related quality of life (QoL) using lung cancer module (LC-13)

Spots Global Cancer Trial Database for durvalumab 1500 mg iv