PROSPECT-LUNG: A National Clinical Trials Network Trial Advancing Pragmatic Innovation in Cancer Clinical Trials.
Allison Booth, Shauna Hillman, Kristina Laumann...
https://pubmed.ncbi.nlm.nih.gov/41747891/Actively Recruiting
Led by Alliance for Clinical Trials in Oncology · Updated on 2026-08-05
1100
Participants Needed
415
Research Sites
52 weeks
Total Duration
Researchers are comparing two treatment approaches for patients with stage II-IIIB non-small cell lung cancer NSCLC that can be removed by surgery. The study evaluates whether giving standard therapy before and after surgery perioperative is better than giving it only after surgery adjuvant. This phase III trial focuses on chemotherapy and immunotherapy, which are current standard treatments aimed at controlling tumor growth and helping the immune system fight cancer. Patients are divided into two groups. One group undergoes surgery followed by chemotherapy and immunotherapy for up to one year if the disease does not progress or cause severe side effects. The other group receives chemotherapy combined with immunotherapy before surgery, then surgery, followed by immunotherapy alone for up to one year. Chemotherapy drugs may include cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, or vinorelbine. Imaging tests like CT, MRI, or PETCT scans are done throughout the study. Participants will have surgery within a month of joining and receive treatments according to their assigned group. They will be monitored with scans and followed up every six months for up to 10 years to assess survival, disease progression, surgical outcomes, side effects, and immune responses. Researchers will measure event-free survival and overall survival as main results, as well as response rates and safety information over the long term.
CONDITIONS
Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non-small Cell Lung Cancer
K
Kathryn Kelley, MPH
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Alliance for Clinical Trials in Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Neoadjuvant systemic therapy, then surgery and adjuvant systemic therapy | Surgery followed by adjuvant systemic therapy |
|---|---|---|
| What is it? | Participants receive protocol-based neoadjuvant systemic therapy—including chemotherapy and possibly immunotherapy—prior to surgery, followed by post-surgical (adjuvant) systemic therapy as clinically indicated. | Patients undergo complete surgical resection first, then receive protocol-defined adjuvant systemic therapy, which may include platinum-based chemotherapy, and immune checkpoint inhibitors such as nivolumab, pembrolizumab, or atezolizumab, based on tumor histology and eligibility. |
| Role in this trial | Examines whether giving systemic therapy before and after surgery improves outcomes compared to adjuvant-only therapy. | Serves as a direct comparator for evaluating outcomes of immediate surgery with standard adjuvant systemic therapy. |
| Primary use or goal | To determine if adding pre-operative systemic therapy to the treatment sequence results in better event-free and overall survival than adjuvant therapy alone. | To reduce the risk of disease recurrence and improve overall survival through surgical tumor removal followed by adjuvant systemic treatment. |
| How is it given? | Participants are treated with intravenous systemic therapy—potentially both chemotherapy and immunotherapy drugs—before surgery, with additional post-surgical therapy according to protocol and pathology results. | After surgery, patients receive intravenous chemotherapy and, for some, immune checkpoint inhibitors as per protocol. Dosing and schedule are chosen according to clinical criteria and tumor characteristics. |
| Evidence status | Multiple recent clinical trials support the use of neoadjuvant systemic therapy in resectable NSCLC, but longer-term real-world effectiveness data are still being collected. | Substantial published evidence and guideline recommendations support the use of surgery followed by adjuvant chemotherapy or immunotherapy for resectable stage II-III NSCLC. |
| Important limitations | Risks include incomplete tumor response to neoadjuvant therapy, potential disease progression during neoadjuvant phase, or perioperative complications impacting post-surgical treatment. The ideal sequencing for all patients is not yet established. | Not all eligible patients may tolerate adjuvant systemic therapy after surgery, and delays or adverse events may limit treatment completion. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 year for immunotherapy; chemotherapy cycles and surgery timing vary
Participants are randomly assigned to one of two groups: surgery followed by chemotherapy and immunotherapy, or chemotherapy and immunotherapy before surgery followed by immunotherapy after surgery. Chemotherapy is given in up to 4 cycles and immunotherapy for up to 1 year if tolerated and without disease progression.
Surgery within 28 days of registration; chemotherapy cycles and immunotherapy visits per guidelines
Duration - Up to 10 years
Participants are monitored with CT scans and possibly MRI or PET/CT scans throughout the study and followed every 6 months for up to 10 years to assess survival, disease progression, and side effects.
Follow-up visits every 6 months
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Allison Booth, Shauna Hillman, Kristina Laumann...
https://pubmed.ncbi.nlm.nih.gov/41747891/Alliance for Clinical Trials in Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborating Sponsor