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
National Cancer Institute (NCI)
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.
Description
PRIMARY OBJECTIVE: I. To evaluate whether there is an improvement in overall survival (OS) with chemotherapy combined with pembrolizumab compared to single agent pembrolizumab in this vulnerable older adult patient population. SECONDARY OBJECTIVES: I. To evaluate any difference in progression free survival (PFS) with chemotherapy combined with pembrolizumab as compared to single agent pembrolizumab. II. To evaluate the difference in PFS rate at 3 months and at 6 months with chemotherapy combined with pembrolizumab as compared to single agent pembrolizumab. III. To evaluate the difference…
Eligibility
- Age range
- 70+ years
- Sex
- All
- Healthy volunteers
- No
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 kina…
Interventions
- DrugCarboplatin
Given IV
- ProcedureComputed Tomography
Undergo CT scan
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- DrugNab-paclitaxel
Given IV
- DrugPaclitaxel
Given IV
- BiologicalPembrolizumab
Given IV
- DrugPemetrexed
Given IV
Locations (318)
- Highlands Oncology Group - FayettevilleFayetteville, Arkansas
- Mercy Hospital Fort SmithFort Smith, Arkansas
- Highlands Oncology Group - RogersRogers, Arkansas
- Highlands Oncology GroupSpringdale, Arkansas
- Kaiser Permanente DublinDublin, California
- Kaiser Permanente-FremontFremont, California