Pembrolizumab for Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Lung Cancer+3 More
Pembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a combination of drugs to treat squamous cell non-small cell lung cancer. The drugs are given to see if they work better than just the chemotherapy drugs carboplatin and gemcitabine.

Eligible Conditions
  • Lung Cancer
  • Malignant Neoplasms
  • Carcinoma, Squamous Cell, Non-small-cell Lung

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Up to 12 months post treatment

Month 12
PFS in the subset of patients with ATM-deficient squamous cell non-small cell lung cancer
Progression-free survival (PFS) (Phase 2)
Month 12
ATM assay
Determination if features of whole exome and ribonucleic acid (RNA) sequencing are predictive OR, OS, or PFS
Inflammation
Overall response (OR)
Overall survival (OS)
Worst grade of adverse events
Up to completion of cycle 1
Recommended phase 2 dose (RP2D) (Phase 1B)

Trial Safety

Safety Progress

1 of 3

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 B (pembrolizumab, gemcitabine, carboplatin)
1 of 2
Arm A (pembrolizumab, gemcitabine, carboplatin, M6620)
1 of 2
Active Control
Experimental Treatment

106 Total Participants · 2 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 1 & 2

Arm A (pembrolizumab, gemcitabine, carboplatin, M6620)Experimental Group · 7 Interventions: Computed Tomography, Magnetic Resonance Imaging, Biospecimen Collection, Carboplatin, Berzosertib, Gemcitabine Hydrochloride, Pembrolizumab · Intervention Types: Procedure, Procedure, Procedure, Drug, Drug, Drug, Biological
Arm B (pembrolizumab, gemcitabine, carboplatin)ActiveComparator Group · 6 Interventions: Computed Tomography, Magnetic Resonance Imaging, Biospecimen Collection, Carboplatin, Gemcitabine Hydrochloride, Pembrolizumab · Intervention Types: Procedure, Procedure, Procedure, Drug, Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~3410
Magnetic Resonance Imaging
2017
Completed Phase 2
~1100
Biospecimen Collection
2004
Completed Phase 1
~670
Carboplatin
FDA approved
Gemcitabine
FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months post treatment

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
12,989 Previous Clinical Trials
41,298,952 Total Patients Enrolled
Liza C VillaruzPrincipal InvestigatorUniversity of Pittsburgh Cancer Institute LAO
1 Previous Clinical Trials
66 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must have tumor tissue available at time of enrollment, or be willing to undergo a biopsy for integrated biomarker studies.
Patients with prior immunotherapy given as neoadjuvant, adjuvant, or consolidation therapy for early stage or loco-regionally advanced disease are eligible, if treatment is completed one year prior to initiation of treatment.
You have a performance status of 0-1 (Karnofsky > 60%).
The drug combination of dexamethasone and rituximab is well tolerated in patients with relapsed or refractory Hodgkin lymphoma.
The absolute neutrophil count is greater than the lower limit of normal.
Platelets > 10,000/microL.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 14th, 2021

Last Reviewed: October 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.