A Phase II,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

Official Summary

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

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 446 participants

Interventions

• DRUG: MEDI4736 — MEDI4736 (durvalumab) by intravenous infusion every two weeks. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier. Patients who achieve CR, PR or SD through the end of the initial 12-month treatment period can restart treatment with MEDI4736 (durvalumab) when they eventually do progress. This retreatment period can continue for as long as the investigator considers to patient to be receiving clinical benefit.

Primary Outcomes

• Objective Response Rate (ORR) (Responses recorded during initial 12 month treatment period (up to primary analysis DCO))

Secondary Outcomes

• Time to Response (TTR) (Responses recorded during initial 12 month treatment period (up to primary analysis DCO))
• Duration of Response (DoR) (Time from response to progression, death, or last assessment (up to approximately 2 years 3 months for the primary analysis DCO))
• Overall Survival (OS) (From date of first treatment until final DCO (up to approximately 3 years 8 months))

Eligibility Criteria

Inclusion Criteria:

* Aged at least 18 years.
* 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%of tumour cells with membrane staining (Cohort 1 and 2) or PD-L1 positive with ≥90% 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, treated 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 immune-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)

Trial Locations

• Research Site, Goodyear, Arizona, United States
• Research Site, Santa Rosa, California, United States
• Research Site, New Haven, Connecticut, United States
• Research Site, Port Saint Lucie, Florida, United States
• Research Site, Tampa, Florida, United States
• Research Site, Lawrenceville, Georgia, United States
• Research Site, Waterloo, Iowa, United States
• Research Site, Topeka, Kansas, United States
• Research Site, Bethesda, Maryland, United States
• Research Site, Burlington, Massachusetts, United States
• ...and 10 more locations

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