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Pembrolizumab for Non-Small-Cell Lung Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Non-Small-Cell Lung CarcinomaPembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the combination of pembrolizumab with different chemotherapies and/or other immunotherapy drugs to see if it is more effective and has fewer side effects than other treatments for people with squamous or non-squamous NSCLC.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
risdiplam
1
Talazoparib
1
EDP-323 SAD Cohorts

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to approximately 27 months

Month 24
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Month 27
Number of Participants Who Experience One or More Adverse Events (AEs)

Trial Safety

Safety Progress

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

Similar Trials

1
risdiplam
1
Talazoparib
1
EDP-323 SAD Cohorts

Trial Design

8 Treatment Groups

Pembrolizumab+Vibostolimab+Carboplatin + Paclitaxel
1 of 8
Pembrolizumab+MK-0482+Carboplatin+Paclitaxel
1 of 8
Pembrolizumab+MK-0482+Carboplatin+Pemetrexed
1 of 8
Pembrolizumab+Vibostolimab+Carboplatin + Pemetrexed
1 of 8
Pembrolizumab+MK-5890+Carboplatin+Paclitaxel
1 of 8
Pembrolizumab+MK-5890+Carboplatin+Pemetrexed
1 of 8
Pembrolizumab+MK-4830+Carboplatin+Paclitaxel
1 of 8
Pembrolizumab+MK-4830+Carboplatin+Pemetrexed
1 of 8

Experimental Treatment

360 Total Participants · 8 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

Pembrolizumab+Vibostolimab+Carboplatin + PaclitaxelExperimental Group · 4 Interventions: Pembrolizumab, Vibostolimab, Paclitaxel, Carboplatin · Intervention Types: Biological, Biological, Drug, Drug
Pembrolizumab+MK-0482+Carboplatin+Paclitaxel
Biological
Experimental Group · 1 Intervention: MK-0482 · Intervention Types: Biological
Pembrolizumab+MK-0482+Carboplatin+Pemetrexed
Biological
Experimental Group · 1 Intervention: MK-0482 · Intervention Types: Biological
Pembrolizumab+Vibostolimab+Carboplatin + PemetrexedExperimental Group · 4 Interventions: Pemetrexed, Pembrolizumab, Vibostolimab, Carboplatin · Intervention Types: Drug, Biological, Biological, Drug
Pembrolizumab+MK-5890+Carboplatin+PaclitaxelExperimental Group · 4 Interventions: Pembrolizumab, Paclitaxel, MK-5890, Carboplatin · Intervention Types: Biological, Drug, Biological, Drug
Pembrolizumab+MK-5890+Carboplatin+PemetrexedExperimental Group · 4 Interventions: Pemetrexed, Pembrolizumab, MK-5890, Carboplatin · Intervention Types: Drug, Biological, Biological, Drug
Pembrolizumab+MK-4830+Carboplatin+PaclitaxelExperimental Group · 4 Interventions: Pembrolizumab, Paclitaxel, MK-4830, Carboplatin · Intervention Types: Biological, Drug, Biological, Drug
Pembrolizumab+MK-4830+Carboplatin+PemetrexedExperimental Group · 4 Interventions: Pemetrexed, Pembrolizumab, MK-4830, Carboplatin · Intervention Types: Drug, Biological, Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed
FDA approved
Pembrolizumab
FDA approved
Paclitaxel
FDA approved
Carboplatin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 27 months

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,577,987 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,684 Previous Clinical Trials
4,957,768 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,639 Previous Clinical Trials
7,941,978 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
, whichever is longer A woman who is not able to have children or who agrees to use contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab and for at least 180 days after the last dose of chemotherapy, whichever is longer.
The person has a Stage IV squamous or nonsquamous NSCLC which has been confirmed by histology or cytology.
or chemo-radiotherapy (CRT) may be eligible for pemetrexed Participants with nonsquamous NSCLC who are not eligible for an approved targeted therapy or chemo-radiotherapy (CRT) may be eligible for pemetrexed if they have a performance status of 0-1 and have not received prior chemo-radiotherapy.
We are able to provide archived tumor tissue samples that were collected either within 5 years or within the interval from completion of last treatment but before entering the screening period
The person has not received treatment for their metastatic NSCLC before.
You are able to complete all screening procedures within the 35-day screening window.
The patient will have adequete organ function within 10 days of starting the study treatment.
Male participants who receive pembrolizumab must use contraception and not donate sperm during the treatment period and for at least 120 days after the last dose of pembrolizumab and for at least 180 days after the last dose of chemotherapy.
References

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