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

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

Eligibility Criteria

Sex

ALL

Age

70 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Carboplatin — DRUG
  Given IV
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Nab-paclitaxel — DRUG
  Given IV
• Paclitaxel — DRUG
  Given IV
• Pembrolizumab — BIOLOGICAL
  Given IV
• Pemetrexed — DRUG
  Given IV
• Positron Emission Tomography — PROCEDURE
  Undergo PET
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Jul 19, 2024

Status verified

May 2026

Primary completion

Jan 31, 2035

Completion

Jan 31, 2035

Study Design

Enrollment

304 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A (pembrolizumab)
  INDUCTION: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 or 42 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo MRI at baseline and CT and/or PET on the trial at baseline and throughout the trial.
• Experimental: Arm B (pembrolizumab, chemotherapy)
  See Detailed Description

Primary Outcome Measure

Overall survival (OS) [ Time Frame: 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 ]

Locations (318)

Find similar trials in Fayetteville, AR

Related Studies

• Intravenous and Intrathecal Nivolumab in Treating Patients With Leptomeningeal Disease
  PHASE1 · Recruiting · M.D. Anderson Cancer Center · Houston, Texas
• Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
  PHASE2 · Recruiting · National Cancer Institute (NCI) · Anchorage, Alaska
• Panitumumab-IRDye800 in Detecting Cancer in Participants With Lung Cancer During Surgery
  PHASE1/PHASE2 · Recruiting · Stanford University · Palo Alto, California
• Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer
  PHASE1 · Recruiting · M.D. Anderson Cancer Center · Houston, Texas