Clinical trial · Interventional
A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, International Study of MEDI4736 as Sequential Therapy in Patients With Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy (PACIFIC)
NCT02125461CI-TRIAL-00070316PACIFICcompletedPhase 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)
A Global Study to Assess the Effects of MEDI4736 following concurrent chemoradiation in Patients with Stage III Unresectable Non-Small Cell Lung Cancer.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MEDI4736 | Drug | Durvalumab | ALIAS |
| PLACEBO | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MEDI4736
- description
- MEDI4736 (intravenous infusion)
- interventionNames
- Drug: MEDI4736
- type
- PLACEBO_COMPARATOR
- label
- PLACEBO
- description
- Placebo (matching placebo for intravenous infusion)
- interventionNames
- Other: PLACEBO
Primary outcomes (2)
- measure
- Progression Free Survival Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
- timeFrame
- Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age at least 18 years. 2. Documented evidence of NSCLC (locally advanced, unresectable, Stage III) 3. Patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy. 4. World Health Organisation (WHO) Performance Status of 0 to 1. 5. Estimated life expectancy of more than 12 weeks. Exclusion Criteria: 1. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody. 2. Active or prior autoimmune disease or history of immunodeficiency. 3. Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV. 4. Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris. 5. Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy. 6. Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
References
Publications (16)
- DERIVEDBrunetti L, Santo V, Pinato DJ, Citarella F, Orlando S, Acker F, Colella V, Ricciuti B, Naidoo J, Nassar A, Wakelee HA, Takada K, Naqash AR, Garassino MC, Greco C, Ramella S, Pantano F, Tonini G, Vincenzi B, Arlunno B, Remon J, Parisi C, Planchard D, Besse B, Desilets A, Routy B, Elkrief A, Barlesi F, Derosa L, Cortellini A. Differential impact of proton pump inhibitors and antibiotics on immunotherapy efficacy after chemoradiotherapy in locally advanced non-small-cell lung cancer: a post-hoc analysis of the PACIFIC trial. Lancet Oncol. 2026 Aug;27(8):1043-1056. doi: 10.1016/S1470-2045(26)00191-9. Epub 2026 Jul 3. PMID 42398520
- DERIVEDNaidoo J, Antonia S, Wu YL, Cho BC, Thiyagarajah P, Mann H, Newton M, Faivre-Finn C. Brief Report: Durvalumab After Chemoradiotherapy in Unresectable Stage III EGFR-Mutant NSCLC: A Post Hoc Subgroup Analysis From PACIFIC. J Thorac Oncol. 2023 May;18(5):657-663. doi: 10.1016/j.jtho.2023.02.009. Epub 2023 Feb 24. PMID 36841540
- DERIVEDSenan S, Ozguroglu M, Daniel D, Villegas A, Vicente D, Murakami S, Hui R, Faivre-Finn C, Paz-Ares L, Wu YL, Mann H, Dennis PA, Antonia SJ. Outcomes with durvalumab after chemoradiotherapy in stage IIIA-N2 non-small-cell lung cancer: an exploratory analysis from the PACIFIC trial. ESMO Open. 2022 Apr;7(2):100410. doi: 10.1016/j.esmoop.2022.100410. Epub 2022 Mar 2. PMID 35247871
- DERIVEDNaidoo J, Vansteenkiste JF, Faivre-Finn C, Ozguroglu M, Murakami S, Hui R, Quantin X, Broadhurst H, Newton M, Thiyagarajah P, Antonia SJ. Characterizing immune-mediated adverse events with durvalumab in patients with unresectable stage III NSCLC: A post-hoc analysis of the PACIFIC trial. Lung Cancer. 2022 Apr;166:84-93. doi: 10.1016/j.lungcan.2022.02.003. Epub 2022 Feb 9. PMID 35245844
- DERIVEDSpigel DR, Faivre-Finn C, Gray JE, Vicente D, Planchard D, Paz-Ares L, Vansteenkiste JF, Garassino MC, Hui R, Quantin X, Rimner A, Wu YL, Ozguroglu M, Lee KH, Kato T, de Wit M, Kurata T, Reck M, Cho BC, Senan S, Naidoo J, Mann H, Newton M, Thiyagarajah P, Antonia SJ. Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. J Clin Oncol. 2022 Apr 20;40(12):1301-1311. doi: 10.1200/JCO.21.01308. Epub 2022 Feb 2.