Comparing Treatment Timing for Stage II-IIIB Resectable Non-small Cell Lung Cancer

Sponsor: Alliance for Clinical Trials in Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06632327

Provider View

This study is exploring whether starting treatment before surgery, in addition to after surgery, is more effective than only treating after surgery for patients with stage II-IIIB non-small cell lung cancer that can be surgically removed.

Patient Parameters

Program Overview

This phase III clinical trial is investigating the best timing for treatment in patients with stage II-IIIB non-small cell lung cancer (NSCLC) that can be surgically removed. The study compares the usual approach of giving chemotherapy and/or immunotherapy after surgery to giving these treatments both before and after surgery. The goal is to determine which approach is more effective in treating lung cancer. Chemotherapy options may include drugs like cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and vinorelbine. Immunotherapy may involve drugs such as nivolumab, pembrolizumab, and atezolizumab, which help the immune system attack cancer cells. The study aims to find out if starting treatment before surgery and continuing it afterward is better than only treating after surgery.

Description

The study has two main parts:

Primary Objectives:

  • To compare the 3-year survival rates and overall survival between patients receiving treatment before and after surgery (perioperative) and those receiving treatment only after surgery (adjuvant).

Secondary Objectives:

  • To compare the success rates of surgery between the two groups.
  • To compare the rates of complete tumor removal between the two groups.
  • To summarize and compare side effects that lead to stopping treatment, hospitalization, or death between the two groups.
  • To evaluate the link between complete tumor response and survival in patients receiving treatment before surgery.
  • To compare survival rates beyond 3 years for patients who do not experience cancer recurrence by that time.

Exploratory Objectives:

  • To compare outcomes based on the specific treatments given in each group.
  • To compare where cancer returns between the two treatment groups.

Study Design:

  • Arm 1 (Adjuvant Therapy): Patients undergo surgery and then receive chemotherapy and immunotherapy for up to 1 year, unless the cancer progresses or side effects are too severe.
  • Arm 2 (Perioperative Therapy): Patients receive chemotherapy and immunotherapy before surgery, undergo surgery, and then continue with immunotherapy for up to 1 year, unless the cancer progresses or side effects are too severe.

Patients will have regular CT scans and may have MRI or PET/CT scans during the study. After treatment, patients will be followed up every 6 months for up to 10 years.

Eligibility Criteria

Inclusion Criteria

  • Have stage IIA to IIIB non-small cell lung cancer that can be surgically removed.
  • Be 18 years or older.
  • Have a performance status that allows for daily activities with some limitations.
  • Have not received systemic treatment for lung cancer in the past 5 years, except for early-stage cancers treated with the intent to cure.
  • Have not been treated for another cancer in the past 3 years, except for certain early-stage cancers.
  • Do not have active autoimmune disease, lung disease, or a transplant that would make immune therapy unsafe.
  • HIV-positive patients can participate if they are on effective treatment with an undetectable viral load.

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