Pembrolizumab for Non-Small Cell Lung Carcinoma (NSCLC)

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Non-Small Cell Lung Carcinoma (NSCLC)+11 More
Pembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the addition of the immunotherapy drug pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB IIIA or IIIB non-small cell lung cancer.

Eligible Conditions
  • Non-Small Cell Lung Carcinoma (NSCLC)
  • Stage IIIB Lung Cancer AJCC v8
  • Malignant Neoplasms
  • Stage IIA Lung Cancer AJCC v8
  • Carcinoma, Squamous Cell, Non-small-cell Lung
  • Stage IIB Lung Cancer AJCC v8

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Up to 10 years

Year 8
OS between combination pembrolizumab with standard of care vs. sequential pembrolizumab
OS between each experimental pembrolizumab plus standard of care arms vs. standard of care
Overall survival (OS)
Year 5
DFS between combination pembrolizumab with standard of care versus (vs.) sequential pembrolizumab
DFS between each experimental pembrolizumab plus standard of care arms vs. standard of care
Disease free survival (DFS)
Up to 10 years
Incidence of adverse events

Trial Safety

Safety Progress

3 of 3
This is further along than 85% 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

3 Treatment Groups

Arm A (platinum doublet, observation)
1 of 3
Arm C (platinum doublet, combination pembrolizumab)
1 of 3
Arm B (platinum doublet, sequential pembrolizumab)
1 of 3

Active Control

Experimental Treatment

1210 Total Participants · 3 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 3

Arm C (platinum doublet, combination pembrolizumab)Experimental Group · 8 Interventions: Questionnaire Administration, Pembrolizumab, Gemcitabine Hydrochloride, Paclitaxel, Quality-of-Life Assessment, Pemetrexed Disodium, Cisplatin, Carboplatin · Intervention Types: Other, Biological, Drug, Drug, Other, Drug, Drug, Drug
Arm B (platinum doublet, sequential pembrolizumab)Experimental Group · 8 Interventions: Questionnaire Administration, Pembrolizumab, Gemcitabine Hydrochloride, Paclitaxel, Quality-of-Life Assessment, Pemetrexed Disodium, Cisplatin, Carboplatin · Intervention Types: Other, Biological, Drug, Drug, Other, Drug, Drug, Drug
Arm A (platinum doublet, observation)ActiveComparator Group · 8 Interventions: Questionnaire Administration, Gemcitabine Hydrochloride, Observation, Paclitaxel, Quality-of-Life Assessment, Pemetrexed Disodium, Cisplatin, Carboplatin · Intervention Types: Other, Drug, Other, Drug, Other, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Gemcitabine
FDA approved
Paclitaxel
FDA approved
Pemetrexed
FDA approved
Cisplatin
FDA approved
Carboplatin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 10 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,000 Previous Clinical Trials
41,299,697 Total Patients Enrolled
80 Trials studying Non-Small Cell Lung Carcinoma (NSCLC)
19,546 Patients Enrolled for Non-Small Cell Lung Carcinoma (NSCLC)
Jacob M SandsPrincipal InvestigatorAlliance for Clinical Trials in Oncology

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 19th, 2021

Last Reviewed: November 11th, 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.

Who else is applying?

What state do they live in?
California100.0%
What site did they apply to?
Kaiser Permanente-San Francisco100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%