Actively Recruiting
Perioperative Versus Adjuvant Systemic Therapy in Patients With Resectable Non-Small Cell Lung Cancer - PROSPECT LUNG
Led by Alliance for Clinical Trials in Oncology · Updated on 2026-06-02
1100
Participants Needed
378
Research Sites
52 weeks
Total Duration
On this page
Sponsors
A
Alliance for Clinical Trials in Oncology
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two treatment approaches for patients with stage II to IIIB non-small cell lung cancer NSCLC that can be surgically removed. The study evaluates whether giving standard therapy both before and after surgery perioperative is more effective than giving it only after surgery adjuvant. The trial is phase III and aims to understand which approach leads to better survival and fewer complications in patients with resectable lung cancer. Participants are randomly assigned to one of two treatment groups. In the first group, patients have surgery within 28 days of joining the study, followed by up to four cycles of platinum-based chemotherapy and up to one year of immunotherapy if the cancer does not progress or cause unacceptable side effects. In the second group, patients receive chemotherapy combined with immunotherapy before surgery, then undergo surgery, and continue immunotherapy after surgery for up to one year under similar conditions. Throughout the study, patients may have CT scans, and possibly MRI or PETCT scans at the start. During the trial, researchers will monitor patients closely over time, including follow-up visits every six months for up to 10 years after treatment ends. They will assess outcomes such as survival without events like cancer recurrence or progression, overall survival, rates of surgery and complete tumor removal, side effects leading to treatment stops or hospitalizations, and the bodys response to treatment. This comprehensive monitoring helps evaluate the benefits and risks of each treatment approach.
CONDITIONS
Brief Title
Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed surgically resectable stage IIA to IIIB non-small cell lung cancer according to AJCC 9th edition (up to single station N2 per AJCC 8th edition)
- Patients with resectable stage N2a or T4 are eligible; patients with stage N2b or N3 are not eligible
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 or Karnofsky score 60% or higher
- No prior systemic treatment for NSCLC within 5 years except for stage 1 or 2 cancers treated with curative intent
- No treatment for another malignancy within 3 years prior to registration except for certain early-stage cancers treated with curative intent and disease-free for one year
- No active autoimmune disease, interstitial lung disease, or transplant that prevents safe treatment with immune checkpoint inhibitors
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible
You will not qualify if you...
- Patients with stage N2b or N3 non-small cell lung cancer
- Patients with known EGFR or ALK genetic alterations
- Active autoimmune diseases or interstitial lung disease that preclude safe immunotherapy
- History of organ transplant that prevents safe treatment with immune checkpoint inhibitors
- Prior systemic treatment for NSCLC within 5 years except for stage 1 or 2 cancers treated with curative intent
- Treatment for another malignancy within 3 years prior to registration except certain early-stage cancers treated curatively and disease-free for one year
Research Team
K
Kathryn Kelley, MPH
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