Study of Durvalumab Given With Chemoradiation Therapy in Patients With Unresectable Non-small Cell Lung Cancer

NCT ID: NCT03519971

Last Updated: 2025-10-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 328 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-29
• Study Completion Date: 2025-12-01

Brief Summary

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, international study assessing the efficacy and safety of durvalumab given concurrently with platinum-based CRT (durvalumab + standard of care [SoC] CRT) in patients with locally advanced, unresectable NSCLC (Stage III).

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1: Durvalumab + platinum-based chemotherapy and radiation

Durvalumab ((MEDI4736) in concurrence with platinum-based chemo-radiation therapy.

All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on Investigator discretion, in addition to radiation therapy:

• cisplatin/etoposide
• carboplatin/paclitaxel
• pemetrexed/cisplatin
• pemetrexed/carboplatin

At the completion of standard of care chemoradiation therapy (SoC CRT), patients with complete response, partial response or stable disease will continue to receive durvalumab as consolidation treatment.

Group Type: EXPERIMENTAL

Durvalumab

Intervention Type: DRUG

Durvalumab IV (intravenous infusion)

Cisplatin/ Etoposide

Intervention Type: DRUG

Cisplatin/ Etoposide, as per standard of care

Carboplatin/ Paclitaxel

Intervention Type: DRUG

Carboplatin /Paclitaxel, as per standard of care

Pemetrexed/ Cisplatin

Intervention Type: DRUG

Pemetrexed / Cisplatin, as per standard of care

Pemetrexed/ Carboplatin

Intervention Type: DRUG

Pemetrexed / Carboplatin , as per standard of care

Radiation

Intervention Type: RADIATION

5 fractions/ week for \~6 weeks (±3 days) (Total 60 Gy)

Arm 2: Placebo + platinum-based chemotherapy and radiation

Placebo in concurrence with platinum-based chemo-radiation therapy.

All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on Investigator discretion, in addition to radiation therapy:

• cisplatin/etoposide
• carboplatin/paclitaxel
• pemetrexed/cisplatin
• pemetrexed/carboplatin

At the completion of standard of care chemoradiation therapy (SoC CRT), patients with complete response, partial response or stable disease will continue to receive placebo as consolidation treatment.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo IV (intravenous infusion)

Cisplatin/ Etoposide

Intervention Type: DRUG

Cisplatin/ Etoposide, as per standard of care

Carboplatin/ Paclitaxel

Intervention Type: DRUG

Carboplatin /Paclitaxel, as per standard of care

Pemetrexed/ Cisplatin

Intervention Type: DRUG

Pemetrexed / Cisplatin, as per standard of care

Pemetrexed/ Carboplatin

Intervention Type: DRUG

Pemetrexed / Carboplatin , as per standard of care

Radiation

Intervention Type: RADIATION

5 fractions/ week for \~6 weeks (±3 days) (Total 60 Gy)

Interventions

Durvalumab

Durvalumab IV (intravenous infusion)

Intervention Type: DRUG

Placebo

Placebo IV (intravenous infusion)

Intervention Type: OTHER

Cisplatin/ Etoposide

Cisplatin/ Etoposide, as per standard of care

Intervention Type: DRUG

Carboplatin/ Paclitaxel

Carboplatin /Paclitaxel, as per standard of care

Intervention Type: DRUG

Pemetrexed/ Cisplatin

Pemetrexed / Cisplatin, as per standard of care

Intervention Type: DRUG

Pemetrexed/ Carboplatin

Pemetrexed / Carboplatin , as per standard of care

Intervention Type: DRUG

Radiation

5 fractions/ week for \~6 weeks (±3 days) (Total 60 Gy)

Intervention Type: RADIATION

Other Intervention Names

MEDI4736

Eligibility Criteria

Inclusion Criteria

• Subjects with histologically- or cytologically-documented NSCLC
• Locally advanced, unresectable (Stage III) NSCLC
• World Health Organisation (WHO) performance status 0-1
• At least one measurable lesion, not previously irradiated
• Must have a life expectancy of at least 12 weeks at randomization

Exclusion Criteria

• Receipt of prior or current cancer treatment, including but not limited to, radiation therapy, investigational agents, chemotherapy, Durvalumab and mAbs.
• Prior exposure to immune-mediated therapy, including but not limited to, other anti CTLA-4, anti-PD-1, anti-PD-L1, and anti PD L2 antibodies, excluding therapeutic anticancer vaccines.
• History of allogeneic organ transplantation
• Active or prior documented autoimmune or inflammatory disorders
• Uncontrolled intercurrent illness
• History of another primary malignancy / leptomeningeal carcinomatosis / active primary immunodeficiency
• Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus
• Mixed small cell and NSCLC histology
• Any medical contraindication to treatment with platinum-based doublet chemotherapy as listed in the local labelling
• Known allergy or hypersensitivity to any of the IPs or any of the IP excipients.
• Patients whose radiation treatment plans are likely to encompass a volume of whole lung receiving ≥20 Gy in total (V20) of more than 35% of lung volume.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 130 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Bradley, MD

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca

Locations

Research Site

Barretos, , Brazil

Research Site

Curitiba, , Brazil

Research Site

Florianópolis, , Brazil

Research Site

Fortaleza, , Brazil

Research Site

Porto Alegre, , Brazil

Research Site

Porto Alegre, , Brazil

Research Site

Porto Alegre, , Brazil

Research Site

Ribeirão Preto, , Brazil

Research Site

Ribeirão Preto, , Brazil

Research Site

São José do Rio Preto, , Brazil

Research Site

São Paulo, , Brazil

Research Site

Brno, , Czechia

Research Site

Ostrava, , Czechia

Research Site

Prague, , Czechia

Research Site

Budapest, , Hungary

Research Site

Budapest, , Hungary

Research Site

Győr, , Hungary

Research Site

Gyula, , Hungary

Research Site

Törökbálint, , Hungary

Research Site

Bangalore, , India

Research Site

Chennai, , India

Research Site

Gurgaon, , India

Research Site

Karamsad, , India

Research Site

Mumbai, , India

Research Site

Nashik, , India

Research Site

New Delhi, , India

Research Site

Vadodara, , India

Research Site

Bunkyō City, , Japan

Research Site

Fukuoka, , Japan

Research Site

Kōtoku, , Japan

Research Site

Kyoto, , Japan

Research Site

Nagoya, , Japan

Research Site

Sayama, , Japan

Research Site

Sendai, , Japan

Research Site

Yokohama, , Japan

Research Site

Aguascalientes, , Mexico

Research Site

Guadalajara, , Mexico

Research Site

Mexico City, , Mexico

Research Site

Mérida, , Mexico

Research Site

México, , Mexico

Research Site

Orizaba, , Mexico

Research Site

La Libertad, , Peru

Research Site

Lima, , Peru

Research Site

Lima, , Peru

Research Site

Lima, , Peru

Research Site

Lima, , Peru

Research Site

Lima, , Peru

Research Site

Cebu City, , Philippines

Research Site

City of Taguig, , Philippines

Research Site

Iloilo City, , Philippines

Research Site

Makati, , Philippines

Research Site

Manila, , Philippines

Research Site

Quezon City, , Philippines

Research Site

Bydgoszcz, , Poland

Research Site

Elblag, , Poland

Research Site

Gdansk, , Poland

Research Site

Olsztyn, , Poland

Research Site

Warsaw, , Poland

Research Site

Arkhangelsk, , Russia

Research Site

Chelyabinsk, , Russia

Research Site

Moscow, , Russia

Research Site

Moscow, , Russia

Research Site

Moscow, , Russia

Research Site

Omsk, , Russia

Research Site

Rostov-on-Don, , Russia

Research Site

Saint Petersburg, , Russia

Research Site

Busan, , South Korea

Research Site

Chungcheongbuk-do, , South Korea

Research Site

Gyeongsangnam-do, , South Korea

Research Site

Seoul, , South Korea

Research Site

Seoul, , South Korea

Research Site

Seoul, , South Korea

Research Site

Bangkok, , Thailand

Research Site

Bangkok, , Thailand

Research Site

Hat Yai, , Thailand

Research Site

Khon Kaen, , Thailand

Research Site

Mueang, , Thailand

Research Site

Ankara, , Turkey (Türkiye)

Research Site

Ankara, , Turkey (Türkiye)

Research Site

Antalya, , Turkey (Türkiye)

Research Site

Diyarbakır, , Turkey (Türkiye)

Research Site

Istanbul, , Turkey (Türkiye)

Research Site

Izmir, , Turkey (Türkiye)

Research Site

Hanoi, , Vietnam

Research Site

Hanoi, , Vietnam

Research Site

Ho Chi Minh City, , Vietnam

Countries

Brazil; Czechia; Hungary; India; Japan; Mexico; Peru; Philippines; Poland; Russia; South Korea; Thailand; Turkey (Türkiye); Vietnam

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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SAP

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CSP

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CSR Synopsis

Other Identifiers

2017-004397-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D933KC00001

Identifier Type: -

Identifier Source: org_study_id