← Back to Search

Alkylating agents

Pembrolizumab + Chemotherapy/Radiotherapy for Non-Small Cell Lung Cancer (KEYNOTE-799 Trial)

Phase 2

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Male/female participants, at least 18 years of age with previously untreated, unresectable, pathologically confirmed NSCLC and Stage IIIA, IIIB or IIIC NSCLC by American Joint Committee on Cancer Version 8

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 1 1/4 years

Awards & highlights

KEYNOTE-799 Trial Summary

This trial is testing a new cancer treatment combining immunotherapy and chemotherapy, followed by immunotherapy alone. The goal is to see if this can help people with Stage III non-small cell lung cancer who can't have surgery.

Who is the study for?

Adults with Stage III non-small cell lung cancer (NSCLC) that can't be surgically removed. Participants must be at least 18, have good performance status (ECOG 0 or 1), no metastatic disease, adequate organ and pulmonary function, and agree to use contraception. Excluded are those with prior thoracic radiotherapy, certain immunodeficiencies or treatments, active infections requiring systemic therapy, severe allergies to trial drugs or their components.Check my eligibility

What is being tested?

The trial tests pembrolizumab combined with platinum-based chemotherapy and standard thoracic radiation followed by pembrolizumab alone in NSCLC patients. It aims to see if this combination is safe (specifically looking at pneumonitis rates ≤10%) and effective based on the objective response rate.See study design

What are the potential side effects?

Possible side effects include immune-related inflammation of organs like lungs (pneumonitis), infusion reactions from the drug entering the body, fatigue from treatment exhaustion, blood disorders due to bone marrow suppression by chemotherapy drugs, increased risk of infection due to weakened immune defenses.

KEYNOTE-799 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active or can carry out light work.

Select...

I am 18 or older with a type of lung cancer that hasn't been treated and can't be surgically removed.

Select...

I agree to use birth control and not donate sperm until the end of my treatment.

Select...

My scans show no signs of cancer spread.

KEYNOTE-799 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 1 1/4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 1 1/4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 1 1/4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

Percentage of Participants Who Developed Grade 3 or Higher Pneumonitis

Secondary outcome measures

Number of Participants Who Discontinued From Study Treatment Due to an AE

Number of Participants Who Experienced an Adverse Event (AE)

Overall Survival (OS)

+1 more

KEYNOTE-799 Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort BExperimental Treatment4 Interventions

Participants received 3 cycles of cisplatin 75 mg/m^2 with pemetrexed 500 mg/m^2 and pembrolizumab 200 mg on Day 1 of each cycle. Treatment was given in conjunction with standard TRT (60 Gy in 2 Gy fractions administered 5 days per week for 6 weeks) in cycles 2 and 3. Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.

Group II: Cohort AExperimental Treatment6 Interventions

Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray [Gy] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab 200 mg

2013

Completed Phase 3

~930

Paclitaxel 45 mg/m^2

2018

Completed Phase 2

~220

Carboplatin AUC6

2018

Completed Phase 2

~220

Cisplatin 75 mg/m^2

2013

Completed Phase 2

~310

Pemetrexed 500 mg/m^2

2013

Completed Phase 2

~310

Thoracic Radiation Therapy (TRT)

2018

Completed Phase 3

~820

Paclitaxel 200 mg/m^2

2013

Completed Phase 2

~310

Carboplatin AUC2

2018

Completed Phase 2

~220

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,581,611 Total Patients Enrolled

Merck Sharp & Dohme LLCLead Sponsor

3,886 Previous Clinical Trials

5,054,336 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,269 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03631784 — Phase 2

Non-Small Cell Lung Cancer Research Study Groups: Cohort A, Cohort B

Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03631784 — Phase 2

Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03631784 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this experiment still open?

"At this moment, the trial is not accepting new participants. The clinical study was initially posted on October 19th 2018 and its information last edited on October 6th 2022. For those interested in other trials, there are 1945 active studies looking for individuals with carcinoma non-small cell lung cancer and 2321 ongoing investigations targeting patients suitable to receive Thoracic Radiation Therapy (TRT)."

Answered by AI

How many participants have signed up for the trial to date?

"This clinical trial is not currently taking on new participants. It was initially posted in October 2018 and last updated in October 2022. Alternately, there are 1945 studies for carcinoma non-small cell lung cancer which actively recruiting as well as 2321 studies focusing on Thoracic Radiation Therapy (TRT) that are also registering patients."

Answered by AI

Has Thoracic Radiation Therapy attained FDA authorization?

"Our evaluation assigned Thoracic Radiation Therapy (TRT) a score of 2, given that Phase 2 trials have provided some proof for safety but none for efficacy."

Answered by AI

What venues are presently offering this trial?

"Currently, this trial is enlisting patients from 10 distinct medical centres. Worcester, New Brunswick and Detroit are some of the cities with a recruitment site present. To reduce travel time for participants, it's advised to choose the closest available location."

Answered by AI

What key objectives has this research endeavor been set to accomplish?

"The primary purpose of this three-year study is to analyse the Overall Response Rate (ORR) for patients using the RECIST 1.1 guidelines. Secondary objectives include recording and analysing any Adverse Events that occur in participants, assessing Progression Free Survival per RECIST 1.1 criteria, as well as measuring PFS from enrollment until death or disease progression."

Answered by AI

What findings have been reported in prior experiments related to Thoracic Radiation Therapy (TRT)?

"The first research on Thoracic Radiation Therapy (TRT) was published in 1997 at the City of Hope Comprehensive Cancer Center. Fast forward to today, and there have been 2610 completed studies as well as 2321 active trials with a major concentration located in Worcester, Massachusetts."

Answered by AI

What maladies are typically addressed with Thoracic Radiation Therapy (TRT)?

"Thoracic Radiation Therapy (TRT) is a common form of management for malignant neoplasms. This technique may also be beneficial in the treatment of other illnesses such as unresectable melanoma, microsatellite instability high and locally advanced nonsquamous non-small cell lung cancer."

Answered by AI

Recent research and studies

JAMA OncologyJournal

Pembrolizumab Plus Concurrent Chemoradiation Therapy in Patients with Unresectable, Locally Advanced, Stage III Non–small Cell Lung Cancer

Jabbour, Salma K., Ki Hyeong Lee, Nikolaj Frost, Valeriy Breder, Dariusz M. Kowalski, Theodore Pollock, Evgeny Levchenko, et al.. 2021. “Pembrolizumab Plus Concurrent Chemoradiation Therapy in Patients with Unresectable, Locally Advanced, Stage III Non–small Cell Lung Cancer”. JAMA Oncology. American Medical Association (AMA). doi:10.1001/jamaoncol.2021.2301.

clinicaltrials.govStudy

A Trial of Pembrolizumab in Combination With Chemotherapy and Radiotherapy in Stage III NSCLC (KEYNOTE-799, MK-3475-799)

2018. "A Trial of Pembrolizumab in Combination With Chemotherapy and Radiotherapy in Stage III NSCLC (KEYNOTE-799, MK-3475-799)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03631784.