A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 16 October 2023
• Main ID: NCT02352948
• Date of registration: 28/01/2015
• Prospective Registration: No
• Primary sponsor: AstraZeneca
• Public title: A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer ARCTIC
• Scientific title: A Phase III, Open Label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum Based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC).
• Date of first enrolment: January 13, 2015
• Target sample size: 597
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02352948
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Bulgaria, Canada, Chile, Czech Republic, Czechia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Republic of, Netherlands, Philippines, Poland, Romania, Russian Federation, Serbia, Singapore, South Africa, Spain, Taiwan, Thailand, Turkey, United Kingdom, United States

Contacts

• Name: Paul Stockman, MBChB, PhD
• Affiliation: AstraZeneca

Key inclusion & exclusion 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 regimen and
at least 1 additional regimen for treatment of NSCLC

- World Health Organization (WHO) Performance Status of 0 or 1

- Estimated life expectancy more than 12 weeks

Exclusion Criteria:

- Prior exposure to any anti-PD-1 or anti-PD-L1 antibody or anti-CTLA4

- Brain metastases or spinal cord compression unless asymptomatic, treated and stable
(not requiring steroids)

- Active or prior documented autoimmune disease within the past 2 years

- Evidence of severe or uncontrolled systemic disease, including active bleeding
diatheses or active infections including hepatitis B, C and HIV

- Any unresolved toxicity CTCAE (Common Terminology Criteria of Adverse Events) >Grade 2
from previous anti-cancer therapy

- Known EGFR TK activating mutations or ALK rearrangements

- 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)



Age minimum: 18 Years
Age maximum: 130 Years
Gender: All

Health Condition(s) or Problem(s) studied

Non - Small Cell Lung Cancer NSCLC

Intervention(s)

Drug: Erlotinib

Drug: Gemcitabine

Drug: MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4)

Drug: tremelimumab (anti-CTLA4)

Drug: Vinorelbine

Drug: MEDI4736 (durvalumab)

Primary Outcome(s)

Overall Survival (OS) [Time Frame: From randomization (Day 1) until death due to any cause, approximately 36 months]

Progression-Free Survival (PFS) [Time Frame: Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.]

Secondary Outcome(s)

Percentage of Participants Alive and Progression Free at 6 Months (APF6) [Time Frame: Tumour scans performed at baseline then every ~8 weeks up to 6 months]

Percentage of Participants Alive at 12 Months (OS12) [Time Frame: From randomization (Day 1) up to 12 months]

Duration of Response (DoR) [Time Frame: Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.]

PFS, Contribution of the Components Analysis of Sub-study B [Time Frame: Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.]

Objective Response Rate (ORR) [Time Frame: Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.]

OS, Contribution of the Components Analysis of Sub-study B [Time Frame: From randomization (Day 1) until death due to any cause, approximately 36 months]

Percentage of Participants Alive and Progression Free at 12 Months (APF12) [Time Frame: Tumour scans performed at baseline then every ~8 weeks up to 12 months.]

Time From Randomisation to Second Progression (PFS2) of Sub-study B [Time Frame: Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until first progression. Disease then assessed per local practice until 2nd progression. Assessed up to a maximum of approximately 3 years.]

Secondary ID(s)

2014-000338-46

D4191C00004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/04/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02352948