A study to assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer in terms of efficacy, safety and tolerability

A Phase 2, Non-comparative, Open Label, Multi-centre, International Study of MEDI4736, in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received at Least 2 Prior Systemic Treatment Regimens Including 1 Platinum-based Chemotherapy Regimen (ATLANTIC)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222742

Enrollment

Registered

2015-02-03

Start date

2014-08-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Interventions

investigational material(s) Generic name etc : MEDI4736 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Documented evidence of NSCLC (stage IIIB/IV disease) - Disease progression or recurrence after both a platinum-based chemotherapy and at least 1 additional regimen for treatment of NSCLC - World Health Organisation (WHO) Performance Status of 0 or 1 - Estimated life expectancy of more than 12 weeks - Patient's tumour sample must be PD-L1 positive (25% or more of tumour cells with membrane staining (Cohort 1 and 2) or PD-L1 positive with 90% or more of tumour cells with membrane staining (Cohort 3))

Exclusion criteria

Exclusion criteria: - Prior exposure to any anti-PD-1 or anti-PD-L1 antibody. - Brain metastases or spinal cord compression or unless asymptomatic, treate d and stable (not requiring steroids ). - Active or prior autoimmune disease or history of immunodeficiency. - Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV. - Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris. - Any unresolved toxicity CTCAE >Grade 2 from previous anti-cancer therapy. - Any prior Grade 3 or more 3 immune or more-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1. - Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).

Design outcomes

Primary

Measure	Time frame
Objective Response Rate (ORR) Patients commenced treatment with durvalumab on Day 1 and continued on a Q2W schedule for a maximum of 12 months. Tumor assessments using computed tomography / magnetic resonance imaging were performed every 8 weeks. Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) measurements as given by the Independent Central Review (ICR) were used to derive the primary variable of ORR .	—

Measure

Time frame

Objective Response Rate (ORR) Patients commenced treatment with durvalumab on Day 1 and continued on a Q2W schedule for a maximum of 12 months. Tumor assessments using computed tomography / magnetic resonance imaging were performed every 8 weeks. Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) measurements as given by the Independent Central Review (ICR) were used to derive the primary variable of ORR .

—

Countries

Australia, Belgium, Canada, Czech Republic, France, Germany, Hungary, Italy, Philippines, Poland, Singapore, South Korea, Spain, Taiwan, Thailand, United Kingdom, United States of America

Contacts

Public ContactKazushige Hibi

Astrazeneka K.K

RD-clinical-information-Japan@astrazeneca.com+81-6-4802-3600

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026