PACIFIC2

A Phase 3, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab Given Concurrently With Platinum-based Chemoradiation Therapy in Patients With Locally Advanced, Unresectable Non-small Cell Lung Cancer (Stage 3)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223897

Enrollment

300

Registered

2018-05-11

Start date

2018-04-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Interventions

investigational material(s) Generic name etc : Durvalumab, Cisplatin/ Etoposide, Carboplatin/ Paclitaxel, Pemetrexed/ Cisplatin, Pemetrexed/ Carboplatin, Radiation INN of investigational material : T

Eligibility

Sex/Gender

All

Inclusion 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

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 more than in total (V20) of more than 35% of lung volume.

Design outcomes

Primary

Measure	Time frame
Progression-Free Survival (PFS) The PFS per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) using blinded independent central review (BICR) assessments was defined as the time from the date of randomization until the date of objective PD or death (by any cause in the absence of progression) regardless of whether the participant withdrew from therapy or received another anti-cancer therapy prior to progression. The PD was defined as at least a 20% increase in the sum of diameters of target lesions. Median PFS was calculated using the Kaplan-Meier technique. Tumour scans performed at screening, 16 weeks +-1 week after randomization, then every 8 weeks +-1 week up to 48 weeks, and then every 12 weeks +-1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days).	—

Measure

Time frame

Progression-Free Survival (PFS) The PFS per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) using blinded independent central review (BICR) assessments was defined as the time from the date of randomization until the date of objective PD or death (by any cause in the absence of progression) regardless of whether the participant withdrew from therapy or received another anti-cancer therapy prior to progression. The PD was defined as at least a 20% increase in the sum of diameters of target lesions. Median PFS was calculated using the Kaplan-Meier technique. Tumour scans performed at screening, 16 weeks +-1 week after randomization, then every 8 weeks +-1 week up to 48 weeks, and then every 12 weeks +-1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days).

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Countries

Brazil, Czech Republic, France, Hungary, India, Mexico, Peru, Philippines, Poland, Russian Federation, South Korea, Taiwan, Thailand, Turkey, Ukraine, Vietnam

Contacts

Public ContactKazushige Hibi

Astrazeneka K.K

RD-clinical-information-Japan@astrazeneca.com+81-6-4802-3600

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026