Clinical trial · Interventional
A Phase 1b Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Non-small Cell Lung Cancer
A Phase 1b Open-label Study to Evaluate the Safety and Tolerability of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Non-small Cell Lung Cancer
NCT02000947CI-TRIAL-00041380D4190C00006completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if MEDI4736 will be adequately tolerated in combination with tremelimumab in subjects with advanced non-small cell lung cancer (NSCLC).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MEDI4736 | Drug | Durvalumab | ALIAS |
| Tremelimumab | Drug | Tremelimumab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- MEDI4736 and tremelimumab received by intravenous infusion.
- interventionNames
- Drug: MEDI4736
- Drug: Tremelimumab
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Medi4736 and tremelimumab received by intravenous infusion
- interventionNames
- Drug: MEDI4736
- Drug: Tremelimumab
- type
- EXPERIMENTAL
- label
- Arm B
- description
- MEDI4736 and tremelimumab received by intravenous infusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 101 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years 2. Advanced non-small cell lung cancer 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 4. Adequate organ and marrow function Exclusion Criteria: 1. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment 2. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs 3. Active or prior documented autoimmune disease within the last 2 years.
References
Publications (2)
- DERIVEDGaron EB, Spira AI, Goldberg SB, Chaft JE, Papadimitrakopoulou V, Cascone T, Antonia SJ, Brahmer JR, Camidge DR, Powderly JD, Wozniak AJ, Felip E, Wu S, Ascierto ML, Elgeioushi N, Awad MM. Brief Report: Safety and Antitumor Activity of Durvalumab Plus Tremelimumab in Programmed Cell Death-(Ligand)1-Monotherapy Pretreated, Advanced NSCLC: Results From a Phase 1b Clinical Trial. J Thorac Oncol. 2023 Aug;18(8):1094-1102. doi: 10.1016/j.jtho.2023.04.020. Epub 2023 May 4. PMID 37146752
- DERIVEDAntonia S, Goldberg SB, Balmanoukian A, Chaft JE, Sanborn RE, Gupta A, Narwal R, Steele K, Gu Y, Karakunnel JJ, Rizvi NA. Safety and antitumour activity of durvalumab plus tremelimumab in non-small cell lung cancer: a multicentre, phase 1b study. Lancet Oncol. 2016 Mar;17(3):299-308. doi: 10.1016/S1470-2045(15)00544-6. Epub 2016 Feb 6. PMID 26858122