Durvalumab and Tremelimumab for Adjuvant Therapy of Resected NSCLC
NCT03130764 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2017-12-06
Summary
Despite aggressive surgery and chemotherapy, the risk of lung cancer recurrence remains high in most patients. This study aims to determine if a novel immune therapy consisting of two drugs is feasible and potentially increases the chance of cure in lung cancer patients after surgery and standard chemotherapy. The immune-based therapy being given in this study consists of two medications named durvalumab and tremelimumab.
Conditions
Interventions
- DRUG
-
1500 mg, IV over 1 hour Every 4 weeks for 1 year
- DRUG
-
Tremelimumab
75 mg, IV over 1 hour Every 4 weeks for 4 doses
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Adrian Sacher, M.D. · Columbia University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-03-31
- Primary Completion
- 2017-11-30
- Completion
- 2017-11-30
- FDA Drug
- Yes
More Related Trials
-
A Study of Durvalumab Plus Tremelimumab With Chemotherapy in Untreated ES-SCLC
NCT03963414 ·Status: TERMINATED ·Phase: PHASE1
-
Tremelimumab and Durvalumab With or Without Radiation Therapy in Patients With Relapsed Small Cell Lung Cancer
NCT02701400 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy
NCT03703297 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Chemoradiation Plus Durvalumab Followed by Surgery Followed by Adjuvant Durvalumab in Patients With Surgically Resectable Stage III (N2) Non-Small Cell Lung Cancer
NCT03871153 ·Status: TERMINATED ·Phase: PHASE2
-
Assess the Safety of Immunotherapy Induction With Tremelimumab and Durvalumab Prior to Chemoradiotherapy and/or Resection in the Treatment
NCT04287894 ·Status: TERMINATED ·Phase: PHASE1
-
Study of Durvalumab + Tremelimumab in NSCLC Patients After Adjuvant Treatment
NCT04625699 ·Status: WITHDRAWN ·Phase: PHASE2
-
Gemcitabine Hydrochloride and Carboplatin With or Without MK-0646 as First-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
NCT00951444 ·Status: WITHDRAWN ·Phase: PHASE2
-
Immune Neoadjuvant Therapy Study of Durvalumab in Early Stage Non-small Cell Lung Cancer
NCT03030131 ·Status: TERMINATED ·Phase: PHASE2
-
Durvalumab, Tremelimumab, and Selumetinib in Treating Participants With Recurrent or Stage IV Non-small Cell Lung Cancer
NCT03581487 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Concurrent Neoadjuvant Chemoradiotherapy Plus Durvalumab (MEDI4736) in Resectable Stage III NSCLC
NCT03694236 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Neoadjuvant LDRT Combined With Durvalumab in Potentially Resectable Stage III NSCLC
NCT05157542 ·Status: UNKNOWN ·Phase: PHASE1
-
Safety and Effect of Pertuzumab in Patients With Advanced Non-Small Cell Lung Cancer, Which Has Progressed After Prior Chemotherapy
NCT00063154 ·Status: COMPLETED ·Phase: PHASE2
-
Gemcitabine, Carboplatin or Paclitaxel Plus Radiation Therapy in Treating Patients With Stage IIIA or IIIB Non-Small Cell Lung Cancer
NCT00016315 ·Status: COMPLETED ·Phase: PHASE1
-
A Safety Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Non-small Cell Lung Cancer
NCT03048136 ·Status: WITHDRAWN ·Phase: PHASE3
-
Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC
NCT03822351 ·Status: COMPLETED ·Phase: PHASE2
-
Gemcitabine, Carboplatin, and Bortezomib in Advanced or Recurrent Non-Small Cell Lung Cancer
NCT00075751 ·Status: COMPLETED ·Phase: PHASE2
-
Immune Profiling of Stage III Non-small Cell Lung Cancer Patients Treated With Concurrent Chemoradiation and Adjuvant Durvalumab: A Prospective Observational Phase II Trial
NCT04432142 ·Status: ACTIVE_NOT_RECRUITING
-
Trametinib, Combination Chemotherapy, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery
NCT01912625 ·Status: TERMINATED ·Phase: PHASE1
-
Radiation and Chemotherapy With Ipilimumab Followed by Nivolumab for Patients With Stage III Unresectable Non-Small Cell Lung Cancer (NSCLC)
NCT03663166 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery
NCT04026412 ·Status: COMPLETED ·Phase: PHASE3
-
Imaging Tumor-infiltrating T-cells in Non-small Cell Lung Cancer
NCT03853187 ·Status: COMPLETED ·Phase: PHASE2
-
Neoadjuvant Immunotherapy With Durvalumab (MEDI4736) in Non-Surgical Early Stage or Locally Advanced Non-Small Cell Lung Cancer (NSCLC) Followed by Radical Radiotherapy or Chemoradiotherapy
NCT05267392 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Nivolumab in Treating Patients With Advanced Metastatic Non-small Cell Lung Cancer
NCT03121417 ·Status: WITHDRAWN ·Phase: PHASE2
-
Trastuzumab Plus Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer
NCT00003881 ·Status: COMPLETED ·Phase: PHASE2
-
Nivolumab in Treating Patients With Stage IV or Recurrent Lung Cancer With High Mutation Loads
NCT03023904 ·Status: WITHDRAWN ·Phase: PHASE2