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Monoclonal Antibodies

Arm B (pembrolizumab, chemotherapy) for Lung Cancer

Phase 3

Recruiting

Led By Megan A Baumgart

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to documented disease progression per response evaluation criteria in solid tumors (recist) 1.1 or death from any cause, whichever occurs first, assessed up to 5 years

Awards & highlights

Study Summary

"This trial is comparing the benefits of using chemotherapy along with immunotherapy (pembrolizumab) versus just using immunotherapy alone to treat patients with advanced lung cancer. The goal is to see

Who is the study for?

This trial is for older adults (70+) with stage IIIB-IV non-small cell lung cancer and a PD-L1 score of 1-49%. They must have adequate blood counts, not be candidates for chemo-radiation, and lack certain gene mutations. An ECOG status of 2 is required, indicating they can perform self-care but cannot work. Participants must agree to avoid fathering children during the study.Check my eligibility

What is being tested?

The ACHIEVE trial compares adding chemotherapy (Pemetrexed, Nab-paclitaxel, Paclitaxel or Carboplatin) to immunotherapy (pembrolizumab) versus just immunotherapy alone in treating lung cancer. It will assess if combining these treatments helps stabilize the disease better than immunotherapy by itself.See study design

What are the potential side effects?

Possible side effects include immune system reactions that may affect organs, infusion-related symptoms like fever or chills, fatigue from treatment burden on the body's energy resources, digestive issues such as nausea or diarrhea due to chemotherapy's effect on rapidly dividing cells including those in the gut lining.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to documented disease progression per response evaluation criteria in solid tumors (recist) 1.1 or death from any cause, whichever occurs first, assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to documented disease progression per response evaluation criteria in solid tumors (recist) 1.1 or death from any cause, whichever occurs first, assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to documented disease progression per response evaluation criteria in solid tumors (recist) 1.1 or death from any cause, whichever occurs first, assessed up to 5 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 survival

Secondary outcome measures

Best objective response

Evaluation of quality of life (QOL) measures

Incidence of adverse events

+2 more

Other outcome measures

Gut microbe abundances

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm B (pembrolizumab, chemotherapy)Experimental Treatment11 Interventions

See Detailed Description

Group II: Arm A (pembrolizumab)Active Control7 Interventions

INDUCTION: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 or 42 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo MRI at baseline and CT and/or PET on the trial at baseline and throughout the trial. Patients may also undergo stool sample collection at baseline and on the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5380

Computed Tomography

2017

Completed Phase 2

~2720

Pemetrexed

2014

Completed Phase 3

~5250

Carboplatin

2014

Completed Phase 3

~6670

Nab-paclitaxel

2014

Completed Phase 3

~2030

Pembrolizumab

2017

Completed Phase 2

~2010

Positron Emission Tomography

2008

Completed Phase 2

~2240

Biospecimen Collection

2004

Completed Phase 2

~1700

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,669 Previous Clinical Trials

40,926,097 Total Patients Enrolled

Megan A BaumgartPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Frequently Asked Questions

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

In how many distinct locations is this investigation currently being conducted?

"There are four active sites for this investigation, including Lankenau Medical Center in Wynnewood, Riddle Memorial Hospital in Media, and Bryn Mawr Hospital in Bryn Mawr."

Answered by AI

Are participants currently being actively recruited for this study?

"Affirmative. Records on clinicaltrials.gov indicate that this research endeavor is presently seeking individuals for participation. Initially shared on November 11, 2024, and last modified on March 1, 2024, the trial aims to enroll a total of 304 volunteers from four distinct locations."

Answered by AI

What is the current number of individuals receiving medical care as part of this research project?

"Indeed, the details on clinicaltrials.gov confirm that this research endeavor is actively seeking eligible participants. This investigative study was initially disclosed on November 11th, 2024 and underwent its most recent revision on March 1st, 2024. The objective is to enroll a total of 304 patients distributed among four distinct sites."

Answered by AI

What levels of risk are associated with Arm B (pembrolizumab, chemotherapy) for individuals?

"Our evaluation at Power rates the safety of Arm B (pembrolizumab with chemotherapy) as 3, reflecting our confidence due to the Phase 3 trial's established efficacy and extensive safety data."

Answered by AI