Study Comparing Chemotherapy Plus Immunotherapy vs. Immunotherapy Alone for Older Adults with Advanced Lung Cancer (ACHIEVE Trial)

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06096844

Provider View

This clinical trial is exploring whether adding chemotherapy to immunotherapy is more effective than using immunotherapy alone in treating older adults with advanced lung cancer. The study aims to see if this combination can improve survival and control the cancer better.

Patient Parameters

Program Overview

This study is testing if combining chemotherapy with the immunotherapy drug pembrolizumab is more effective than using pembrolizumab alone for treating older adults with advanced lung cancer (stage IIIB-IV). Immunotherapy helps the immune system attack cancer cells, while chemotherapy stops cancer cells from growing and spreading. The goal is to see if this combination can better stabilize lung cancer.

Description

The main goal of this study is to find out if adding chemotherapy to pembrolizumab improves overall survival in older adults with advanced lung cancer compared to using pembrolizumab alone. Researchers will also look at how long patients live without the cancer getting worse, the response rate to the treatment, and any side effects. They will also assess patients' quality of life during the study.

Participants will be randomly assigned to one of two groups:

  • Group A (Immunotherapy Only): Patients receive pembrolizumab through an IV every 21 days for 4 cycles. If the cancer does not progress and there are no severe side effects, they continue receiving pembrolizumab every 21 or 42 days for up to 2 years.

  • Group B (Chemotherapy + Immunotherapy): Patients receive pembrolizumab and a chemotherapy regimen chosen by the doctor. Options include combinations of drugs like pemetrexed, carboplatin, nab-paclitaxel, and paclitaxel. Treatment is given every 21 days for 4 cycles, followed by pembrolizumab alone every 21 or 42 days for up to 2 years if the cancer does not progress and there are no severe side effects.

All participants will have imaging tests like MRI, CT, or PET scans at the start and during the study to monitor the cancer. Stool samples may also be collected.

After finishing the study treatment, patients will have follow-up visits every 3 months for the first 2 years and every 6 months for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Must be 70 years or older.
  • Have confirmed non-small cell lung cancer (NSCLC) with a PD-L1 score of 1-49%.
  • Have stage IIIB, IIIC, or IV lung cancer and not be suitable for combined chemo-radiation.
  • Tumor must not have certain genetic mutations that require different treatments.
  • Have a performance status score of 2, meaning some limitations but able to care for oneself.
  • Agree not to father children during the study and for 6 months after treatment.
  • Able to understand and sign a consent form, or have a representative to do so.
  • Meet specific blood count and organ function requirements.
  • HIV-positive patients must have an undetectable viral load.
  • Hepatitis B and C infections must be under control or treated.
  • No symptomatic brain metastases unless treated and stable.
  • No prior chemotherapy or immunotherapy for metastatic disease.
  • No uncontrolled autoimmune conditions, except for certain stable conditions.
  • Not on high-dose immunosuppressive medications.
  • Must complete a Geriatric Assessment before randomization.

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