Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC)

Conditions

• Non-Small-Cell Lung Carcinoma NSCLC

Eligibility Criteria

Sex

ALL

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• MEDI4736 (Durvalumab) — BIOLOGICAL
• MEDI4736 (Durvalumab)+Tremelimumab — BIOLOGICAL
• Paclitaxel + Carboplatin — DRUG
  Chemotherapy Agents
• Gemcitabine + Cisplatin — DRUG
  Chemotherapy Agents
• Gemcitabine + Carboplatin — DRUG
  Chemotherapy Agents
• Pemetrexed + Cisplatin — DRUG
  Chemotherapy Agents
• Pemetrexed + Carboplatin — DRUG
  Chemotherapy Agents
• Tremelimumab — BIOLOGICAL

Study Details

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally advanced or metastatic NSCLC

Key Dates

Start date

Jul 21, 2015

Status verified

May 2026

Primary completion

Oct 4, 2018

Completion

Dec 31, 2026

Study Design

Enrollment

1,118 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Monotherapy
  PD-L1 monoclonal Antibody monotherapy.
• Experimental: Combination Therapy
  PD-L1+Tremelimumab combination therapy
• Active Comparator: Standard of Care
  Standard of Care chemotherapy treatment

Primary Outcome Measure

Overall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy [ Time Frame: From baseline (Day 1, Week 0) until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years). ]

Locations (35)

Find similar trials in Scottsdale, AZ