Durvalumab for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Stanford University, Stanford, CANon-Small Cell Lung Cancer+2 MoreDurvalumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if adding chemotherapy to the standard treatment can lower the number of cancer cells in the blood.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 2 years

12 weeks
Change in ctDNA Level Following Chemotherapy
Presence of Detectable ctDNA Following Chemotherapy
13 months
Durvalumab related Adverse Events (Cohort 1 MRD+ only)
2 years
Overall Survival (OS)
Progression free survival (PFS)

Trial Safety

Safety Progress

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

Side Effects for

DUR + R-CHOP
60%Fatigue
49%Peripheral sensory neuropathy
47%Neutropenia
40%Nausea
28%Diarrhoea
26%Decreased appetite
26%Insomnia
23%Headache
23%Alopecia
23%Dyspnoea
21%Vomiting
21%Constipation
21%Pyrexia
21%Dizziness
21%Dysgeusia
19%Hypokalaemia
19%Cough
19%Stomatitis
16%Leukopenia
16%Dry mouth
16%Anaemia
16%Rash
16%Weight decreased
16%Myalgia
14%Back pain
14%Oropharyngeal pain
14%Febrile neutropenia
12%Infusion related reaction
12%Oedema peripheral
12%Oral candidiasis
12%Abdominal pain upper
9%Thrombocytopenia
9%Urinary tract infection
9%Fall
9%Mucosal inflammation
9%Chills
9%Pruritus
7%Muscle spasms
7%Dry skin
7%Abdominal pain
7%Hypotension
7%Pain in extremity
7%Arthralgia
7%Hot flush
7%Lung infection
7%Vision blurred
7%Nasopharyngitis
7%Hypomagnesaemia
5%General physical health deterioration
5%Dysuria
5%Oral herpes
5%Atrial fibrillation
5%Pneumonia
5%Influenza
5%Infection
2%Tumour pain
2%Pulmonary embolism
2%Erythema
2%Spinal pain
2%Perirectal abscess
2%Pancytopenia
2%Seborrhoeic dermatitis
2%Deep vein thrombosis
2%Venous thrombosis
2%Gastrooesophageal reflux disease
2%Clear cell renal cell carcinoma
2%Cardiac arrest
2%Viral diarrhoea
2%Myocardial ischaemia
2%Autoimmune hepatitis
2%Device related infection
2%Lymphoma
2%Cerebrovascular accident
2%Restless legs syndrome
2%Acute kidney injury
2%Hyponatraemia
2%Histiocytosis haematophagic
This histogram enumerates side effects from a completed 2022 Phase 2 trial (NCT03003520) in the DUR + R-CHOP ARM group. Side effects include: Fatigue with 60%, Peripheral sensory neuropathy with 49%, Neutropenia with 47%, Nausea with 40%, Diarrhoea with 28%.

Trial Design

2 Treatment Groups

Cohort 1 minimal residual disease positive (MRD+)
1 of 2
Cohort 2 minimal residual disease negative (MRD )
1 of 2

Experimental Treatment

48 Total Participants · 2 Treatment Groups

Primary Treatment: Durvalumab · No Placebo Group · Phase 3

Cohort 1 minimal residual disease positive (MRD+)Experimental Group · 6 Interventions: Pemetrexed, AVENIO ctDNA Surveillance Kit, Carboplatin, Durvalumab, Cisplatin, Paclitaxel · Intervention Types: Drug, Device, Drug, Drug, Drug, Drug
Cohort 2 minimal residual disease negative (MRD )Experimental Group · 2 Interventions: AVENIO ctDNA Surveillance Kit, Durvalumab · Intervention Types: Device, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed
FDA approved
Carboplatin
FDA approved
Durvalumab
FDA approved
Cisplatin
FDA approved
Paclitaxel
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Joel NealLead Sponsor
3 Previous Clinical Trials
58 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,182 Previous Clinical Trials
35,790,705 Total Patients Enrolled
Maximilian DiehnLead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,014 Previous Clinical Trials
240,372,617 Total Patients Enrolled
Maximilian Diehn, MDPrincipal InvestigatorStanford Universiy

Eligibility Criteria

Age 18+ · All Participants · 17 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You may need to receive additional chemotherapy with specific drugs (carboplatin and pemetrexed or carboplatin and paclitaxel) as part of the study.

Frequently Asked Questions

Are patients presently being enrolled in this medical study?

"Yes, the trial is still recruiting according to the information on clinicaltrials.gov. This particular study was posted on 8/25/2021 and was updated 8/31/2021. They are looking for 48 patients from 1 site." - Anonymous Online Contributor

Unverified Answer

Is this a large-scale study or a smaller one?

"Yes, this is an ongoing trial that is currently seeking participants. According to the information available on clinicaltrials.gov, the trial was first posted on 8/25/2021, and the most recent update was on 8/31/2021. They are looking for 48 participants total, at 1 site." - Anonymous Online Contributor

Unverified Answer

For what purpose is Durvalumab most often prescribed?

"Durvalumab can be used as a therapeutic intervention for patients suffering from malignant neoplasms, locally advanced nonsquamous non-small cell lung cancer, and conditioning regimens for allogeneic stem cell transplantation therapy." - Anonymous Online Contributor

Unverified Answer

Is Durvalumab known to have any negative health effects?

"Power has given Durvalumab a safety score of 3. This is based on the fact that it is a Phase 3 trial, which suggests that not only is there some evidence of its efficacy, but also that there is repeated evidence of its safety." - 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.