MEDI4736 for Non-Small Cell Lung Cancer

Research Site, Lublin, Poland
Non-Small Cell Lung CancerMEDI4736 - Drug
Eligibility
18 - 130
All Sexes
What conditions do you have?
Select

Study 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

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 12 Secondary · Reporting Duration: 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.

Year 4
Time to Deterioration of Global Health Status / Health-Related Quality of Life (HRQoL), Assessed Using European Organization for Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30)
Malignant Neoplasms
Year 4
Time to Second Progression or Death (PFS2)
Year 4
Overall Survival
Percentage of Patients Alive at 24 Months (OS24)
Week 48
Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations
Week 48
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab
Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab
Year 3
Proportion of Patients Alive and Progression Free at 12 Months From (APF12) Based on BICR Assessments According to RECIST 1.1
Proportion of Patients Alive and Progression Free at 18 Months From (APF18) Based on BICR Assessments According to RECIST 1.1
Year 4
Duration of Response (DoR) Based on BICR Assessments According to RECIST 1.1
Objective Response Rate (ORR) Based on BICR Assesments According to RECIST 1.1
Time to Death or Distant Metastasis (TTDM) Based on BICR Assessments According to RECIST 1.1
Year 3
Progression Free Survival Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Side Effects for

Standard of Care (SoC)
23%Anaemia
23%Asthenia
20%Decreased appetite
17%Nausea
15%Rash
15%Fatigue
13%Neutropenia
13%Diarrhoea
12%Constipation
12%Alopecia
12%Pyrexia
11%Stomatitis
10%Neck pain
10%Neuropathy peripheral
8%Vomiting
8%Thrombocytopenia
8%Weight decreased
8%Dyspnoea
8%Cough
8%Hypomagnesaemia
8%Dysphagia
7%Dermatitis acneiform
7%Mucosal inflammation
7%Alanine aminotransferase increased
7%Headache
6%Aspartate aminotransferase increased
5%Gamma-glutamyltransferase increased
5%Leukopenia
4%Pruritus
4%Pneumonia
3%Blood alkaline phosphatase increased
3%Hypertension
3%Hyponatraemia
3%Insomnia
3%Hypercalcaemia
2%Sepsis
2%Hypothyroidism
1%Lung infection
1%Pneumonia aspiration
1%Respiratory failure
1%Death
1%Tumour haemorrhage
1%Device occlusion
1%Localised infection
1%Asphyxia
This histogram enumerates side effects from a completed 2020 Phase 3 trial (NCT02369874) in the Standard of Care (SoC) ARM group. Side effects include: Anaemia with 23%, Asthenia with 23%, Decreased appetite with 20%, Nausea with 17%, Rash with 15%.

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2 Treatment Groups

MEDI4736
1 of 2
PLACEBO
1 of 2

Experimental Treatment

Non-Treatment Group

713 Total Participants · 2 Treatment Groups

Primary Treatment: MEDI4736 · Has Placebo Group · Phase 3

MEDI4736
Drug
Experimental Group · 1 Intervention: MEDI4736 · Intervention Types: Drug
PLACEBO
Other
PlaceboComparator Group · 1 Intervention: PLACEBO · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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.

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,051 Previous Clinical Trials
240,384,153 Total Patients Enrolled
Phil Dennis, MDStudy DirectorAstraZeneca

Eligibility Criteria

Age 18 - 130 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are expected to live for at least another 12 weeks.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.