The ACHIEVE Trial: Chemotherapy and Immunotherapy for Advanced Lung Cancer
The ACHIEVE Trial is studying whether adding chemotherapy (Carboplatin, Nab-paclitaxel, or Paclitaxel) to immunotherapy (pembrolizumab) is more effective than immunotherapy alone for older adults (age 70 and above) with advanced non-small cell lung cancer (Stage IIIB, IIIC, or IV). Immunotherapy like pembrolizumab helps your body's immune system fight cancer, while chemotherapy drugs aim to stop cancer cell growth. To join, you must have non-small cell lung cancer with a specific PD-L1 Tumor Proportion Score (1-49%). Researchers will measure how long patients live (overall survival) for up to 5 years to see if the combined treatment is better. The study is planning to enroll 304 participants, but its current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 304 participants. It compares two treatment approaches: chemotherapy combined with pembrolizumab versus pembrolizumab alone.
- What's involved
- Participants will receive treatments intravenously (IV) and undergo procedures such as CT scans and MRIs. The specific schedule of visits and procedures is not detailed.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for overall survival for up to 5 years after randomization.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06096844
Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial
Recruiting
PHASE3Ages 70+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~304 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:CarboplatinComputed TomographyMagnetic Resonance ImagingNab-paclitaxelPaclitaxelPembrolizumab
At a glance
Recruiting sites
271 of 324 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival (OS)
Measured over From randomization to death from any cause, and patients who are alive at the time of final analysis will be censored at the last date of contact, assessed up to 5 years
Conditions
Where it's being run
324 sites across 37 statesWisconsin51
Illinois29
Michigan29
Ohio25
California20
Minnesota18
Florida16
Missouri13
Study leadership
- Megan A Baumgart · PRINCIPAL_INVESTIGATOR · ECOG-ACRIN Cancer Research Group
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 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 trial measures
- Overall survival (OS)From randomization to death from any cause, and patients who are alive at the time of final analysis will be censored at the last date of contact, assessed up to 5 years
Will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate hazard ratios. Comparison of OS will use a logrank test stratified on the randomization stratification factors with a one-sided type I error rate of 0.025. Other comparisons of groups will be made using the log rank test and Cox modeling.