A clinical trial in patients with Non-small Cell Lung Cancer that have not responded to previous treatment, to investigate the safety, tolerability, and clinical activity of the investigational drugs MEDI4736 (durvalumab) and tremelimumab. The study will look at the effect of these drugs given either as a single agent (MEDI4736 monotherapy) or as combination therapy (MEDI4736 given together with tremelimumab ).

Phase 1

• Conditions: ocally advanced or metastatic squamous or nonsquamous non- small cell lung cancer (NSCLC); MedDRA version: 20.1 Level: PT Classification code 10029520 Term: Non-small cell lung cancer stage IIIA System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: LLT Classification code 10066490 Term: Progression of non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 1002951; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-003715-38-BE
• Lead Sponsor: MedImmune LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-11
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 446

Inclusion Criteria

1. Age = 18 years
2. Histologically confirmed locally advanced or metastatic squamous or nonsquamous NSCLC
3. ECOG performance status of 0 or 1
4. At least 1 measurable lesion according to RECIST Version 1.1
5. At least 1 lesion amenable to biopsy at screening
6. Adequate organ and marrow function
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 147
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 299

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 drug
3. Active or prior documented autoimmune disease within the last 2 years
4. Major surgical procedure within 28 days prior to the first dose of study drug

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified