OncRef

Clinical Trial: NCT06096844

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

Status:

RECRUITING

Phase:

Phase 3

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-10-08

Study Overview

Brief 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.

Official Title

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

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

Intervention / Treatment

  • Drug: Carboplatin
  • Procedure: Computed Tomography
  • Procedure: Magnetic Resonance Imaging
  • Drug: Nab-paclitaxel
  • Drug: Paclitaxel
  • Biological: Pembrolizumab
  • Drug: Pemetrexed
  • Procedure: Positron Emission Tomography
  • Other: Questionnaire Administration

Other Study ID Numbers

  • NCI-2023-08628
  • NCI-2023-08628
  • EA5221
  • EA5221
  • U10CA180820

Start Date (Actual)

2024-07-19

Primary Completion Date (Estimated)

2039-04-01

Study Completion Date (Estimated)

2039-04-01

Enrollment (Estimated)

304

Study Type

Interventional

Phase

Phase 3