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)

Phase 2

Completed

• Conditions: on-Small Cell Lung Cancer

• Registration Number: JPRN-jRCT2080222742
• Lead Sponsor: AstraZeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-03
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: Not specified

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

- 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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified