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MEDI4736 for Non-Small Cell Lung Cancer (PACIFIC Trial)

Phase 3

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

PACIFIC Trial Summary

This trial will study the effects of the immunotherapy drug MEDI4736 in patients with stage III unresectable NSCLC who are also receiving concurrent chemoradiation therapy.

Eligible Conditions

Non-Small Cell Lung Cancer

PACIFIC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival

Progression Free Survival Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

Secondary outcome measures

Duration of Response (DoR) Based on BICR Assessments According to RECIST 1.1

Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab

Objective Response Rate (ORR) Based on BICR Assesments According to RECIST 1.1

+8 more

Side effects data

From 2023 Phase 3 trial • 713 Patients • NCT02125461

36%

Cough

24%

Fatigue

22%

Dyspnoea

18%

Diarrhoea

17%

Arthralgia

17%

Radiation pneumonitis

15%

Pyrexia

15%

Decreased appetite

14%

Nausea

13%

Pruritus

13%

Rash

12%

Upper respiratory tract infection

12%

Constipation

11%

Asthenia

11%

Hypothyroidism

11%

Headache

11%

Back pain

10%

Productive cough

10%

Pneumonia

Pneumonitis

Nasopharyngitis

Insomnia

Musculoskeletal pain

Vomiting

Oedema peripheral

Myalgia

Dry skin

Hyperthyroidism

Anaemia

Bronchitis

Dizziness

Non-cardiac chest pain

Pain in extremity

Urinary tract infection

Hypertension

Hypokalaemia

Paraesthesia

Musculoskeletal chest pain

Lung infection

Atrial fibrillation

Myocardial infarction

Cardiac failure congestive

Sepsis

Herpes zoster

Chronic obstructive pulmonary disease

Acute kidney injury

100%

80%

60%

40%

20%

Study treatment Arm

Durvalumab (MEDI4736)

Placebo

PACIFIC Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MEDI4736Experimental Treatment1 Intervention

MEDI4736 (intravenous infusion)

Group II: PLACEBOPlacebo Group1 Intervention

Placebo (matching placebo for intravenous infusion)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MEDI4736

2016

Completed Phase 3

~5560

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,259 Previous Clinical Trials

288,593,189 Total Patients Enrolled

Phil Dennis, MDStudy DirectorAstraZeneca

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other ongoing trials using MEDI4736?

"As of now, there are 338 ongoing clinical trials investigating MEDI4736. Out of those, 51 have reached Phase 3. MEDI4736 is being studied mostly in Wakayama-shi and Texas, but there are 12902 total locations running trials for this medication."

Answered by AI

Are there any conditions that would make a person ineligible to participate in this research?

"This study is testing a new cancer medication and is only open to patients with non-small-cell lung carcinoma between the ages of 18 and 130. A total of 713 people can take part in this clinical trial."

Answered by AI

Does this research project only allow young people, or are seniors also welcome to participate?

"This study is enrolling people who are older than 18 and younger than 130."

Answered by AI

What are the recorded negative effects of MEDI4736?

"There is some evidence from earlier phases of testing as well as multiple rounds of safety testing that support the use of MEDI4736, so it received a score of 3."

Answered by AI

What are the most popular MEDI4736 treatments?

"MEDI4736 is the most standard form of treatment for unresectable stage iii non-small cell lung cancer. However, this immunotherapy can also help patients with metastatic ureter urothelial carcinoma and advance directives."

Answered by AI

Recent research and studies

Future OncologyJournal

Patient-reported Outcomes with Durvalumab by PD-L1 Expression and Prior Chemoradiotherapy-related Variables in Unresectable Stage III Non-small-cell Lung Cancer

Garassino, Marina C, Luis Paz-Ares, Rina Hui, Corinne Faivre-Finn, Alex Spira, David Planchard, Mustafa Özgüroğlu, et al.. 2021. “Patient-reported Outcomes with Durvalumab by PD-L1 Expression and Prior Chemoradiotherapy-related Variables in Unresectable Stage III Non-small-cell Lung Cancer”. Future Oncology. Future Medicine Ltd. doi:10.2217/fon-2020-1102.

Journal of the National Comprehensive Cancer NetworkJournal

Cost-effectiveness of Durvalumab After Chemoradiotherapy in Unresectable Stage III NSCLC: A US Healthcare Perspective

Mehra, Ranee, Candice Yong, Brian Seal, Marjolijn van Keep, Angie Raad, and Yiduo Zhang. 2021. “Cost-effectiveness of Durvalumab After Chemoradiotherapy in Unresectable Stage III NSCLC: A US Healthcare Perspective”. Journal of the National Comprehensive Cancer Network. Harborside Press, LLC. doi:10.6004/jnccn.2020.7621.

Journal of Thoracic OncologyJournal

Four-year Survival with Durvalumab After Chemoradiotherapy in Stage III Nsclc—an Update from the PACIFIC Trial

Faivre-Finn, Corinne, David Vicente, Takayasu Kurata, David Planchard, Luis Paz-Ares, Johan F. Vansteenkiste, David R. Spigel, et al.. 2021. “Four-year Survival with Durvalumab After Chemoradiotherapy in Stage III Nsclc—an Update from the PACIFIC Trial”. Journal of Thoracic Oncology. Elsevier BV. doi:10.1016/j.jtho.2020.12.015.

Lung CancerJournal