NCT03519971|Active Not RecruitingPhase 3ResultsDMCFDA Drug

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

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)

AstraZeneca ClinicalTrials.gov

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2 other identifiers

D933KC000012017-004397-34

Study Type

interventional

Target

328

Locations

14 countries

Sites

Timeline

RegisteredMay 2018

StartedMar 2018

CompletionDec 2025

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).

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

328

participants targeted

Target at P25-P50 for phase_3 nonsmall-cell-lung-cancer

Timeline

Completed

Started Mar 2018

Longer than P75 for phase_3 nonsmall-cell-lung-cancer

Geographic Reach

14 countries

86 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.7 years study duration

First Submitted

Initial submission to the registry

March 23, 2018

Completed

6 days until next milestone

Study Start

First participant enrolled

March 29, 2018

Completed

1 month until next milestone

First Posted

Study publicly available on registry

May 9, 2018

Completed

5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2023

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

January 7, 2025

Completed

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed

Last Updated

October 28, 2025

Status Verified

October 1, 2025

Enrollment Period

5.4 years

First QC Date

March 23, 2018

Results QC Date

September 6, 2024

Last Update Submit

October 27, 2025

Conditions

Non-Small Cell Lung Cancer

Keywords

Locally Advanced, Unresectable NSCLC, Carcinoma, NSCLC

Outcome Measures

Primary Outcomes (1)

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).

Secondary Outcomes (12)

Objective Response Rate (ORR)
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).
Overall Survival (OS)
From screening until confirmed PD, assessed up to the DCO date (a maximum of approximately 1988 days).
Percentage of Participants Alive at 24 Months From Randomization (OS24)
Month 24
Complete Response Rate (CRR)
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).
Duration of Response (DoR)
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).
+7 more secondary outcomes

Study Arms (2)

Arm 1: Durvalumab + platinum-based chemotherapy and radiation

EXPERIMENTAL

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.

Drug: DurvalumabDrug: Cisplatin/ EtoposideDrug: Carboplatin/ PaclitaxelDrug: Pemetrexed/ CisplatinDrug: Pemetrexed/ CarboplatinRadiation: Radiation

Arm 2: Placebo + platinum-based chemotherapy and radiation

PLACEBO COMPARATOR

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.

Other: PlaceboDrug: Cisplatin/ EtoposideDrug: Carboplatin/ PaclitaxelDrug: Pemetrexed/ CisplatinDrug: Pemetrexed/ CarboplatinRadiation: Radiation

Interventions

DurvalumabDRUG

Durvalumab IV (intravenous infusion)

Also known as: MEDI4736

Arm 1: Durvalumab + platinum-based chemotherapy and radiation

PlaceboOTHER

Placebo IV (intravenous infusion)

Arm 2: Placebo + platinum-based chemotherapy and radiation

Cisplatin/ EtoposideDRUG

Cisplatin/ Etoposide, as per standard of care