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: 19.0Level: PTClassification code 10029520Term: Non-small cell lung cancer stage IIIASystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: LLTClassification code 10066490Term: Progression of non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: PTClassification code 10029519Term: Non-small cell lung cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-22
• Study Completion: 2019-09-17
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 457

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