pembrolizumab for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Non-Small Cell Lung Cancerpembrolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying a gene therapy called Reqorsa given with the drug pembrolizumab to see if it can help to treat patients with previously treated non-small cell lung cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: Approximately 8 months

Approximately 8 months
Progression-free Survival (PFS) - Phase 2
First 21-days at each dose level
Maximum Tolerated Dose (MTD) - Phase 1
Recommended Phase 2 Dose (RP2D) - Phase 1

Trial Safety

Safety Progress

1 of 3

Side Effects for

Pembrolizumab
17%Decreased appetite
16%Fatigue
16%Dyspnoea
16%Cough
15%Anaemia
12%Constipation
12%Hypothyroidism
11%Nausea
11%Diarrhoea
11%Rash
10%Weight decreased
10%Pruritus
10%Asthenia
10%Pyrexia
10%Alanine aminotransferase increased
10%Back pain
9%Arthralgia
9%Aspartate aminotransferase increased
8%Vomiting
8%Chest pain
7%Pneumonia
7%Headache
7%Haemoptysis
6%Hyperthyroidism
6%Upper respiratory tract infection
6%Blood alkaline phosphatase increased
6%Musculoskeletal pain
6%Hypertension
5%Oedema peripheral
5%Pain in extremity
5%Myalgia
5%Insomnia
4%Pneumonitis
4%Dizziness
3%Stomatitis
3%Malaise
2%Death
2%Pleural effusion
2%Pulmonary embolism
2%Leukopenia
1%Pericardial effusion
1%Colitis
1%Neutrophil count decreased
1%Platelet count decreased
1%White blood cell count decreased
1%Autoimmune hepatitis
1%Bronchitis
1%Sepsis
1%Interstitial lung disease
1%Pulmonary haemorrhage
1%Respiratory failure
1%Neutropenia
1%Thrombocytopenia
1%Neuropathy peripheral
1%Peripheral sensory neuropathy
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT02220894) in the Pembrolizumab ARM group. Side effects include: Decreased appetite with 17%, Fatigue with 16%, Dyspnoea with 16%, Cough with 16%, Anaemia with 15%.

Trial Design

4 Treatment Groups

Phase 2 Active Comparator
1 of 4
Phase 2
1 of 4
Phase 1
1 of 4
Phase 2 Combination
1 of 4

Active Control

Experimental Treatment

156 Total Participants · 4 Treatment Groups

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

Phase 1Experimental Group · 3 Interventions: Pembrolizumab Injection [Keytruda], quaratusugene ozeplasmid, pembrolizumab · Intervention Types: Drug, Biological, Drug
Phase 2 CombinationExperimental Group · 3 Interventions: Pembrolizumab Injection [Keytruda], quaratusugene ozeplasmid, pembrolizumab · Intervention Types: Drug, Biological, Drug
Phase 2 Active ComparatorActiveComparator Group · 2 Interventions: Ramucirumab Injection [Cyramza], Docetaxel injection · Intervention Types: Drug, Drug
Phase 2ActiveComparator Group · 2 Interventions: docetaxel, ramucirumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
pembrolizumab
2016
Completed Phase 3
~6490

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 8 months

Who is running the clinical trial?

Genprex, Inc.Lead Sponsor
2 Previous Clinical Trials
183 Total Patients Enrolled
Daniel Morgensztern, MDPrincipal InvestigatorWashington University School of Medicine
3 Previous Clinical Trials
170 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have hemoglobin ≥ 9.0 g/dL ≥ 4 weeks without transfusions.
Patients must have received prior therapy with pembrolizumab or pembrolizumab/platinum-based chemotherapy for at least 3 months and subsequently progressed as confirmed by radiological tumor assessment.
You have an age of at least 18 years.\n
You have histologically or cytologically documented NSCLC with locally advanced or metastatic disease.
Patients with genetic alterations with FDA-approved therapy (such as EGFR or anaplastic lymphoma kinase [ALK] mutations) must have disease progression after treatment with appropriate targeted therapy and must be eligible for immunotherapy as determined by the investigator.
You have a performance score of 0 to 1.
You have an absolute neutrophil count (ANC) of at least 1,500/μL.

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Millennium Oncology100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%