NCT06096844From ClinicalTrials.govRecruiting

Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial

A Randomized Phase III Trial of Chemo-Immunotherapy vs Immunotherapy Alone for the Vulnerable Older Adult With Advanced Non-Small Cell Lung Cancer: The ACHIEVE Study

Advanced Lung Non-Small Cell Carcinoma
Stage IIIB Lung Cancer AJCC v8
Stage IIIC Lung Cancer AJCC v8
Stage IV Lung Cancer AJCC v8

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: National Cancer Institute (NCI)
Enrolment target: 304
Started: 19 July 2024
Main results due: 1 April 2039
Study sites: 325
Registry updated: 24 September 2026

Can you take part?

Aged 70 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria:

* STEP 1 REGISTRATION
* Patient must be ≥ 70 years of age
* Patient must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with PD-L1 Tumor Proportion Score (TPS) range of 1-49%
* Patient must have Stage IIIB, IIIC or IV disease and not be candidates for combined chemo-radiation. NOTE: Prior chemo-radiation therapy (RT) for stage III with recurrence is allowed
* Patient must have a tumor that is negative for EGFR mutation/ALK translocations or other actionable first line mutations in which patients would receive first-line oral tyrosine kinase inhibitors
* Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
* Patient must agree not to father children while on study and for 6 months after the last dose of protocol treatment
* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
* Absolute neutrophil count (ANC) ≥ 1,500/uL (obtained within 14 days prior to Step 1 registration)
* Platelets ≥ 75,000/uL (obtained within 14 days prior to Step 1 registration)
* Hemoglobin (Hgb) ≥ 8.0 g/dL (obtained within 14 days prior to Step 1 registration)
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (obtained within 14 days prior to Step 1 registration)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 3.0 × institutional ULN (obtained within 14 days prior to Step 1 registration)
* Creatinine clearance (CrCL) ≥ 45 mL/min (estimated using Cockcroft-Gault method with actual body weight or measured) (obtained within 14 days prior to Step 1 registration)
* Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months of Step 1 registration are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have undetectable HCV viral
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Patient must be English or Spanish speaking to be eligible for the QOL component of the study

  * NOTE: Sites cannot translate the associated GA or QOL forms
* Patient must not have symptomatic central nervous system disease (CNS) metastases. Patients with a clinical history of CNS metastases or cord compression are eligible if they have been definitively treated and are clinically stable for at least 14 days prior to Step 1 registration and off all steroids for at least 24 hours prior to Step 1 registration. Patients with asymptomatic CNS metastases are eligible
* Patient must not have had any prior cytotoxic chemotherapy regimen for metastatic disease. Chemotherapy given in the setting of adjuvant therapy or locally advanced disease is allowed as long as treatment was completed, and they have fully recovered from treatment related adverse events prior to Step 1 registration
* Patient must not have had any prior immunotherapy for metastatic disease. Immunotherapy given in the setting of adjuvant therapy or locally advanced disease is allowed as long as treatment was completed greater than 6 months prior to Step 1 registration
* Patient must not have a history of uncontrolled autoimmune conditions with the following exceptions, which are allowed: alopecia, vitiligo, rheumatoid arthritis, psoriasis/psoriatic arthritis, Hashimoto's thyroiditis, lupus, inflammatory bowel disease
* Patient must not be on immunosuppressive medication, including steroids (if doses exceed the equivalent of prednisone 10 mg daily). Short courses of steroids which are discontinued prior to randomization are acceptable. Patients on inhaled, intranasal and/or topical steroids are eligible
* Patient must have baseline imaging done assessing all measurable or non-measurable sites of disease within 45 days prior to Step 1 registration
* Investigator must declare their intended chemotherapy regimen should their patient be randomized to Arm B (doublet versus\[vs\] singlet)
* STEP 2 RANDOMIZATION
* Patient must have completed the baseline Geriatric Assessment (GA) after Step 1 registration and prior to Step 2 randomization

What this study is about

In the sponsor’s own words, from the registry.

This phase III trial compares the effect of adding chemotherapy to immunotherapy (pembrolizumab) versus immunotherapy alone in treating patients with stage IIIB-IV lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab and chemotherapy may help stabilize lung cancer.

Study sites(325)

Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas, United States
Recruiting
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
Recruiting
Highlands Oncology Group - Rogers
Rogers, Arkansas, United States
Recruiting
Highlands Oncology Group
Springdale, Arkansas, United States
Recruiting
Kaiser Permanente Dublin
Dublin, California, United States
Active, not recruiting
Kaiser Permanente-Fremont
Fremont, California, United States
Active, not recruiting
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, United States
Active, not recruiting
Kaiser Permanente-Fresno
Fresno, California, United States
Active, not recruiting
Kaiser Permanente- Modesto MOB II
Modesto, California, United States
Active, not recruiting
Kaiser Permanente-Modesto
Modesto, California, United States
Active, not recruiting
Kaiser Permanente-Oakland
Oakland, California, United States
Active, not recruiting
VA Palo Alto Health Care System
Palo Alto, California, United States
Active, not recruiting
Kaiser Permanente-Roseville
Roseville, California, United States
Active, not recruiting
Kaiser Permanente Downtown Commons
Sacramento, California, United States
Active, not recruiting
Kaiser Permanente-South Sacramento
Sacramento, California, United States
Active, not recruiting
Kaiser Permanente-San Francisco
San Francisco, California, United States
Active, not recruiting
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States
Active, not recruiting
Kaiser Permanente San Leandro
San Leandro, California, United States
Active, not recruiting
Kaiser San Rafael-Gallinas
San Rafael, California, United States
Active, not recruiting
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
Active, not recruiting
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States
Active, not recruiting
Kaiser Permanente-South San Francisco
South San Francisco, California, United States
Active, not recruiting
Kaiser Permanente-Vallejo
Vallejo, California, United States
Active, not recruiting
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States
Active, not recruiting
Stamford Hospital/Bennett Cancer Center
Stamford, Connecticut, United States
Recruiting
Veterans Affairs Connecticut Healthcare System-West Haven Campus
West Haven, Connecticut, United States
Recruiting
George Washington University Medical Center
Washington D.C., District of Columbia, United States
Recruiting
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, United States
Recruiting
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States
Recruiting
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States
Recruiting
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Recruiting
Malcom Randall Veterans Administration Medical Center
Gainesville, Florida, United States
Recruiting
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States
Recruiting
The Watson Clinic
Lakeland, Florida, United States
Recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Recruiting
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States
Recruiting
Sacred Heart Hospital
Pensacola, Florida, United States
Recruiting
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States
Recruiting
Moffitt Cancer Center-International Plaza
Tampa, Florida, United States
Recruiting
James A. Haley Veterans Affairs Hospital
Tampa, Florida, United States
Recruiting
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, United States
Recruiting
Moffitt Cancer Center
Tampa, Florida, United States
Recruiting
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, United States
Recruiting
CTCA at Southeastern Regional Medical Center
Newnan, Georgia, United States
Recruiting
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, United States
Active, not recruiting
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Recruiting
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, United States
Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States
Recruiting
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, United States
Recruiting
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States
Recruiting
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States
Recruiting
Rush-Copley Medical Center
Aurora, Illinois, United States
Recruiting
Advocate Outpatient Center - Aurora
Aurora, Illinois, United States
Recruiting
Advocate Good Shepherd Hospital
Barrington, Illinois, United States
Recruiting
SIH Cancer Institute
Carterville, Illinois, United States
Recruiting
Rush MD Anderson Cancer Center
Chicago, Illinois, United States
Recruiting
University of Illinois
Chicago, Illinois, United States
Recruiting
Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States
Recruiting
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, United States
Recruiting
Carle at The Riverfront
Danville, Illinois, United States
Recruiting

Showing 60 of 325 sites — filter to narrow it down. 265 of the 325 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06096844. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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