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Monoclonal Antibodies

Chemotherapy + Immunotherapy vs. Immunotherapy for Advanced 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

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall survival
Secondary study objectives
Best objective response
Evaluation of quality of life (QOL) measures
Incidence of adverse events
+2 more
Other study objectives
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
~5810
Computed Tomography
2017
Completed Phase 2
~2740
Pemetrexed
2014
Completed Phase 3
~5550
Carboplatin
2014
Completed Phase 3
~6120
Nab-paclitaxel
2014
Completed Phase 3
~1950
Pembrolizumab
2017
Completed Phase 2
~2070
Positron Emission Tomography
2011
Completed Phase 2
~2200
Biospecimen Collection
2004
Completed Phase 3
~2020
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,696 Total Patients Enrolled
Megan A BaumgartPrincipal InvestigatorECOG-ACRIN Cancer Research Group
~203 spots leftby Jun 2026
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