Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial
NCT06096844 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 304
Last updated 2026-05-22
Summary
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.
Conditions
- Advanced Lung Non-Small Cell Carcinoma
- Stage IIIB Lung Cancer AJCC v8
- Stage IIIC Lung Cancer AJCC v8
- Stage IV Lung Cancer AJCC v8
Interventions
- PROCEDURE
-
Computed Tomography
Undergo CT scan
- PROCEDURE
-
Magnetic Resonance Imaging
Undergo MRI
- DRUG
-
Given IV
- DRUG
-
Given IV
- BIOLOGICAL
-
Given IV
- DRUG
-
Pemetrexed
Given IV
- PROCEDURE
-
Positron Emission Tomography
Undergo PET
- OTHER
-
Questionnaire Administration
Ancillary studies
- DRUG
-
Given IV
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Megan A Baumgart · ECOG-ACRIN Cancer Research Group
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-19
- Primary Completion
- 2035-01-31
- Completion
- 2035-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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