Clinical trial · Interventional
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)
NCT03519971CI-TRIAL-00117877completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin/ Paclitaxel | Drug | Carboplatin/Paclitaxel Regimen | ALIAS |
| Cisplatin/ Etoposide | Drug | — | UNRESOLVED |
| Durvalumab | Drug | Durvalumab | ALIAS |
| Pemetrexed/ Carboplatin | Drug | — | UNRESOLVED |
| Pemetrexed/ Cisplatin | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
| Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: Durvalumab + platinum-based chemotherapy and radiation
- description
- 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.
- interventionNames
- Drug: Durvalumab
- Drug: Cisplatin/ Etoposide
- Drug: Carboplatin/ Paclitaxel
- Drug: Pemetrexed/ Cisplatin
- Drug: Pemetrexed/ Carboplatin
- Radiation: Radiation
- type
- PLACEBO_COMPARATOR
- label
- Arm 2: Placebo + platinum-based chemotherapy and radiation
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.