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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab Given Concurrently With Platinum-based Chemoradiation Therapy in Patients With Locally Advanced, Unresectable NSCLC (Stage III) (PACIFIC2)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03519971
• Other study ID #: D933KC00001
• Secondary ID: 2017-004397-34
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 29, 2018
• Est. completion date: March 31, 2025

Study information

• Verified date: May 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 328
• Est. completion date: March 31, 2025
• Est. primary completion date: September 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

Principal 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

Principal 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Durvalumab
Durvalumab IV (intravenous infusion)

Other:
• Placebo
Placebo IV (intravenous infusion)

Drug:
• Cisplatin/ Etoposide
Cisplatin/ Etoposide, as per standard of care
• Carboplatin/ Paclitaxel
Carboplatin /Paclitaxel, as per standard of care
• Pemetrexed/ Cisplatin
Pemetrexed / Cisplatin, as per standard of care
• Pemetrexed/ Carboplatin
Pemetrexed / Carboplatin , as per standard of care

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

Locations

Country	Name	City	State
Brazil	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	Sao Paulo
Czechia	Research Site	Brno
Czechia	Research Site	Ostrava
Czechia	Research Site	Praha 2
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Gyor
Hungary	Research Site	Gyula
Hungary	Research Site	Törökbálint
India	Research Site	Bangalore
India	Research Site	Chennai
India	Research Site	Gurgaon
India	Research Site	Karamsad
India	Research Site	Mumbai
India	Research Site	Nasik
India	Research Site	New Delhi
India	Research Site	Vadodara
Japan	Research Site	Bunkyo-ku
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Koto-ku
Japan	Research Site	Kyoto
Japan	Research Site	Nagoya-shi
Japan	Research Site	Osakasayama
Japan	Research Site	Sendai-shi
Japan	Research Site	Yokohama-shi
Korea, Republic of	Research Site	Busan
Korea, Republic of	Research Site	Chungcheongbuk-do
Korea, Republic of	Research Site	Gyeongsangnam-do
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Mexico	Research Site	Aguascalientes
Mexico	Research Site	Guadalajara
Mexico	Research Site	Mérida
Mexico	Research Site	México
Mexico	Research Site	Mexico City
Mexico	Research Site	Orizaba
Peru	Research Site	La Libertad
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Philippines	Research Site	Cebu City
Philippines	Research Site	Iloilo
Philippines	Research Site	Iloilo City
Philippines	Research Site	Makati
Philippines	Research Site	Manila
Philippines	Research Site	Quezon City
Philippines	Research Site	Taguig City
Poland	Research Site	Bydgoszcz
Poland	Research Site	Elblag
Poland	Research Site	Gdansk
Poland	Research Site	Olsztyn
Poland	Research Site	Warszawa
Russian Federation	Research Site	Arkhangelsk
Russian Federation	Research Site	Chelyabinsk
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Omsk
Russian Federation	Research Site	Rostov-on-Don
Russian Federation	Research Site	Saint-Petersburg
Thailand	Research Site	Bangkok
Thailand	Research Site	Bangkok
Thailand	Research Site	Hat Yai
Thailand	Research Site	Khon Kaen
Thailand	Research Site	Mueang
Turkey	Research Site	Ankara
Turkey	Research Site	Ankara
Turkey	Research Site	Antalya
Turkey	Research Site	Diyarbakir
Turkey	Research Site	Istanbul
Turkey	Research Site	Izmir
Vietnam	Research Site	Hanoi
Vietnam	Research Site	Hanoi
Vietnam	Research Site	Ho Chi Minh
Vietnam	Research Site	Ho Chi Minh city

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Brazil,  Czechia,  Hungary,  India,  Japan,  Korea, Republic of,  Mexico,  Peru,  Philippines,  Poland,  Russian Federation,  Thailand,  Turkey,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events		From the date of randomization until disease progression, assessed up to 4 years.
Primary	Progression-free survival (PFS)		From date of randomization until the date of objective disease progression or death, assessed up to 4 years.
Secondary	Overall Survival (OS)		From the date of randomization until death due to any cause, assessed up to 4 years.
Secondary	Objective Response Rate (ORR)		From the date of Randomisaton until the date of objective disease progression or death, assessed up to 4 years
Secondary	Overall Survival at 24 months		From the date of randomization until 24 months
Secondary	Rate of complete response		From the date of Randomisaton until the date of objective disease progression or death, assessed up to 4 years
Secondary	Duration of response (DoR)		From the date of first documented response (RECIST 1.1.) until the first date of documented progression or death in the absence of disease progression, assessed up to 4 years.
Secondary	Disease Control Rate (DCR)		From the date of randomization until 24 weeks.
Secondary	Time from randomization to second progression PFS2		From the date of randomization to the earliest progression event subsequent to that used for the PFS endpoint or death, up to 4 years
Secondary	Time to death or distant metastasis (TTDM)		From the date of randomization to until the first date of distant metastasis or death in the absence of distant metastasis, assessed up to 4 years
Secondary	Presence of ADA for durvalumab in combination with CRT		From the date of randomization until 6 months after date of last IP dose.
Secondary	To assess symptoms and health-related QoL in patients treated with durvalumab + SoC CRT compared with placebo + SoC CRT using EORTC QLQ-C30 v3		From the date of randomisation until PFS2.
Secondary	To assess symptoms and health-related QoL in patients treated with durvalumab + SoC CRT compared with placebo + SoC CRT using QLQ-LC13		From the date of randomisation until PFS2.
Secondary	To assess the PK of durvalumab in blood (peak trough concentration) when in combination with CRT		From the date of randomization until 3 months after date of last IP dose.