Pembrolizumab for Non-Small Cell Lung Cancer

GSK Investigational Site, Jena, Germany
Non-Small Cell Lung CancerPembrolizumab - Drug
Eligibility
18+
All Sexes

Study Summary

This trial is testing if adding niraparib to pembrolizumab maintenance therapy could improve progression-free survival and overall survival in participants with advanced or metastatic non-small cell lung cancer who have achieved stable disease, partial response, or complete response following completion of standard of care first-line platinum-based induction chemotherapy with pembrolizumab.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Treatment Effectiveness

Phase-Based Effectiveness

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

Similar Trials

1
Single
1
osimertinib
2
pembrolizumab

Study Objectives

4 Primary · 17 Secondary · Reporting Duration: Up to approximately 5 years

Year 3
Change from Baseline in HRQoL and symptoms by EORTC QLQ-LC13 (Scores on a scale)
Change from Baseline in Health-related quality of life (HRQoL) and symptoms by EORTC 30-item Core module (EORTC QLQ-C30) (Scores on a scale)
Change from Baseline in Health-related quality of life (HRQoL) and symptoms by EORTC QLQ-C30-item Core module (EORTC QLQ-C30) (Scores on a scale)
Year 3
CNS PFS as assessed by BICR using RANO-BM
Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
PFS as assessed by BICR using RECIST v1.1 by programmed cell death-ligand 1 (PD-L1) status
PFS assessed by BICR using RECIST v 1.1 in complete and partial response (CR/PR) population
PFS assessed by BICR using RECIST v 1.1 in non-squamous histology (NSQ) population
PFS by investigator assessment
PFS by investigator assessment using RECIST v1.1
PFS by programmed cell death-ligand 1 (PD-L1) status
Plasma concentrations of niraparib
Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1
Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 in overall population
Time to Deterioration (TTD) in Lung Symptoms
Time to progression (TTP)
Year 5
OS by PD-L1 status
OS in CR/PR population
OS in NSQ population
Overall survival (OS)
Overall survival (OS) in overall population

Trial Safety

Phase-Based Safety

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

Similar Trials

2
Single
2
osimertinib
3
pembrolizumab

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%Dyspnoea
17%Asthenia
16%Vomiting
14%Dizziness
14%Pyrexia
13%Arthralgia
13%Rash
13%Headache
12%Hypothyroidism
11%Pruritus
11%Insomnia
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%Hypokalaemia
7%Blood creatinine increased
7%Abdominal pain
7%Febrile neutropenia
6%Abdominal pain upper
6%Stomatitis
6%Dysgeusia
6%Erythema
6%Dry skin
5%Blood alkaline phosphatase increased
5%Dyspepsia
5%Dysphagia
5%Chest pain
5%Musculoskeletal pain
5%Hyperthyroidism
5%Hypertension
5%Nasopharyngitis
5%Musculoskeletal chest pain
5%Pain in extremity
4%Hypotension
4%Urinary tract infection
2%Death
2%Pulmonary embolism
2%Acute kidney injury
2%Pneumonitis
2%Atrial fibrillation
1%Hemiparesis
1%Inappropriate antidiuretic hormone secretion
1%Superior vena cava syndrome
1%Neutropenic sepsis
1%Transient ischaemic attack
1%Diabetes mellitus
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%.

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2 Treatment Groups

Participants receiving niraparib plus pembrolizumab
1 of 2
Participants receiving placebo plus pembrolizumab
1 of 2

Experimental Treatment

Non-Treatment Group

666 Total Participants · 2 Treatment Groups

Primary Treatment: Pembrolizumab · Has Placebo Group · Phase 3

Participants receiving niraparib plus pembrolizumabExperimental Group · 2 Interventions: Niraparib, Pembrolizumab · Intervention Types: Drug, Drug
Participants receiving placebo plus pembrolizumabPlaceboComparator Group · 2 Interventions: Placebo, Pembrolizumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 5 years

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,674 Previous Clinical Trials
7,959,198 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,573 Previous Clinical Trials
6,136,424 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your doctor expects you to live for at least 3 months (12 weeks).
References

Frequently Asked Questions

Has Pembrolizumab been cleared by the FDA?

"Pembrolizumab has been studied in Phase 3 trials, so we have some data to support its efficacy. Furthermore, there is extensive safety data supporting the use of this medication." - Anonymous Online Contributor

Unverified Answer

How many people can sign up for this clinical trial in total?

"The trial is currently ongoing, as indicated by the information available on clinicaltrials.gov. This specific study was first posted on October 26th 2020 and was last edited on August 26th 2022. In total, 650 patients are needed for the trial across 32 different enrolment sites." - Anonymous Online Contributor

Unverified Answer

In how many places is this trial being conducted?

"There are a total of 32 enrolment sites for this trial, which are situated in Skokie, Chattanooga, Portland and other locations. If you decide to participate in this study, try to enroll at the location closest to you to reduce travel time commitments." - Anonymous Online Contributor

Unverified Answer

Are new participants being accepted into this experiment right now?

"That is correct, the online information specifies that this trial is currently looking for participants. This particular study was first advertised on October 26th 2020 and was last updated on August 26th 2022. There are 650 slots open for patients across 32 different locations." - Anonymous Online Contributor

Unverified Answer

What are the goals that researchers are hoping to achieve with this experiment?

"The primary objective of this study, as indicated by the sponsor GlaxoSmithKline, is to measure overall survival (OS) over a period of up to 3 years. In addition to the primary outcome, this study will also be measuring secondary outcomes including OS by PD-L1 status and PFS by investigator assessment. The change from baseline in health-related quality of life (HRQoL) and symptoms will also be measured using the EORTC 30-item Core module (EORTC QLQ-C30)." - Anonymous Online Contributor

Unverified Answer

What other research has there been on Pembrolizumab?

"City of Hope first studied pembrolizumab in 2010 and, since then, 18545 clinical trials have completed. Presently, 1094 medical studies are actively recruiting with a high concentration in Skokie, Illinois." - Anonymous Online Contributor

Unverified Answer

For what purpose is Pembrolizumab most commonly prescribed?

"Pembrolizumab is an immunotherapy medication that can be used to effectively treat patients with malignant neoplasms, unresectable melanoma, and microsatellite instability high." - 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.

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