Pembrolizumab for Stage IVA Lung Cancer AJCC v8

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Stage IVA Lung Cancer AJCC v8+11 More
Pembrolizumab - Biological
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing immunotherapy treatment with N-803 and pembrolizumab for advanced non-small cell lung cancer. N-803 may activate natural killer cells so that they can stimulate an immune response to help fight cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Eligible Conditions
  • Stage IVA Lung Cancer AJCC v8
  • Malignant Neoplasms
  • Non-Small Cell Lung Carcinoma
  • Stage IIIB Lung Cancer AJCC v8
  • Stage IIIC Lung Cancer AJCC v8
  • Stage IVB Lung Cancer AJCC v8

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Up to 2 years

Year 2
Duration of response (DoR)
Year 2
Investigator-assessed progression-free survival (IA-PFS)
Up to 2 years
Overall survival

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Pembrolizumab+EP
54%Neutropenia
45%Anaemia
38%Nausea
34%Alopecia
31%Decreased appetite
29%Constipation
27%Fatigue
26%Thrombocytopenia
22%Leukopenia
21%Diarrhoea
20%Cough
17%Asthenia
17%Dyspnoea
16%Vomiting
14%Pyrexia
14%Dizziness
13%Arthralgia
13%Rash
13%Headache
12%Hypothyroidism
11%Insomnia
11%Pruritus
11%Back pain
10%Weight decreased
9%Hyponatraemia
9%Aspartate aminotransferase increased
8%Oedema peripheral
8%Upper respiratory tract infection
8%Alanine aminotransferase increased
8%Pneumonia
7%Abdominal pain
7%Blood creatinine increased
7%Hypokalaemia
7%Febrile neutropenia
6%Abdominal pain upper
6%Stomatitis
6%Dysgeusia
6%Erythema
6%Dry skin
5%Hyperthyroidism
5%Dyspepsia
5%Dysphagia
5%Chest pain
5%Blood alkaline phosphatase increased
5%Musculoskeletal pain
5%Hypertension
5%Nasopharyngitis
5%Musculoskeletal chest pain
5%Pain in extremity
4%Urinary tract infection
4%Hypotension
2%Death
2%Acute kidney injury
2%Pneumonitis
2%Pulmonary embolism
2%Atrial fibrillation
1%Neutropenic sepsis
1%Inappropriate antidiuretic hormone secretion
1%Diabetes mellitus
1%Hemiparesis
1%Transient ischaemic attack
1%Superior vena cava syndrome
1%Pneumothorax
1%Gastritis
1%Aortic aneurysm
1%Sepsis
1%Pleural infection
1%Infusion related reaction
1%Clostridium difficile colitis
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab+EP ARM group. Side effects include: Neutropenia with 54%, Anaemia with 45%, Nausea with 38%, Alopecia with 34%, Decreased appetite with 31%.

Trial Design

2 Treatment Groups

Arm A (standard of care)
1 of 2
Arm B (pembrolizumab, nogapendekin alfa)
1 of 2

Active Control

Experimental Treatment

478 Total Participants · 2 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2 & 3

Arm B (pembrolizumab, nogapendekin alfa)Experimental Group · 2 Interventions: Pembrolizumab, Nogapendekin Alfa · Intervention Types: Biological, Drug
Arm A (standard of care)ActiveComparator Group · 7 Interventions: Docetaxel, Dexamethasone, Cobalamin, Ramucirumab, Folic Acid, Pemetrexed, Gemcitabine · Intervention Types: Drug, Drug, DietarySupplement, Biological, DietarySupplement, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

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

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
384 Previous Clinical Trials
260,332 Total Patients Enrolled
7 Trials studying Stage IVA Lung Cancer AJCC v8
591 Patients Enrolled for Stage IVA Lung Cancer AJCC v8
National Cancer Institute (NCI)NIH
13,000 Previous Clinical Trials
41,300,429 Total Patients Enrolled
70 Trials studying Stage IVA Lung Cancer AJCC v8
8,844 Patients Enrolled for Stage IVA Lung Cancer AJCC v8
John M WranglePrincipal InvestigatorSouthwest Oncology Group

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 29th, 2021

Last Reviewed: November 23rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.