Comparing treatment timing for lung cancer surgery
Perioperative Versus Adjuvant Systemic Therapy in Patients With Resectable Non-Small Cell Lung Cancer - PROSPECT LUNG
PHASE3 · Alliance for Clinical Trials in Oncology · NCT06632327
This study is testing whether giving standard cancer treatment before and after surgery helps people with resectable stage II-IIIB lung cancer live longer and have fewer problems compared to only giving it after surgery.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alliance for Clinical Trials in Oncology (other) |
| Drugs / interventions | nivolumab, pembrolizumab, atezolizumab, chemotherapy, immunotherapy |
| Locations | 377 sites (Birmingham, Alabama and 376 other locations) |
| Trial ID | NCT06632327 on ClinicalTrials.gov |
What this trial studies
This phase III trial evaluates the effectiveness of administering standard therapy before and after surgery (perioperative) versus only after surgery (adjuvant) in patients with resectable stage II-IIIB non-small cell lung cancer (NSCLC). The study aims to determine which treatment approach leads to better event-free survival and overall survival rates. Patients will receive chemotherapy and/or immunotherapy based on current standard care protocols, with various drug options available. The trial will also assess surgical outcomes and adverse events associated with each treatment arm.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed resectable stage IIA to IIIB NSCLC and an ECOG performance status of 2 or lower.
Not a fit: Patients with known EGFR or ALK alterations or those with advanced stage N2b or N3 lung cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could identify a more effective treatment strategy for patients with resectable lung cancer, potentially improving survival rates.
How similar studies have performed: Other studies have explored similar treatment timing approaches in lung cancer, showing promising results, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically or cytologically confirmed surgically resectable stage IIA to IIIB NSCLC according to the American Joint Committee on Cancer (AJCC) 9th edition (stage IIA to IIIB NSCLC up to single station N2, according to the AJCC 8th edition) \* Note: Patients with resectable stage N2a or T4 are eligible, but patients with stage N2b or N3 are not eligible. Patients with known EGFR or ALK alterations are excluded * Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (or Karnofsky ≥ 60%) * No prior systemic treatment for NSCLC within 5 years except stage 1 and 2 cancers treated with curative intent * No treatment for another malignancy within 3 years prior to registration, except for stage 1 or 2 cancers treated for curative intent; patients must be disease free for one year prior to registration. Patients with non-melanoma skin cancer, urothelial carcinoma in situ (Tis), noninvasive papillary carcinoma of the urinary bladder (Ta), prostatic intraepithelial neoplasia (PIN), ductal carcinoma in situ (DCIS) of the breast, or cervical intraepithelial neoplasia (CIN) of the uterine cervix are also eligible * No active autoimmune disease, interstitial lung disease, or transplant that precludes safe treatment with immune checkpoint inhibitors * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
Where this trial is running
Birmingham, Alabama and 376 other locations
- University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States (ACTIVE_NOT_RECRUITING)
- Cancer Center at Saint Joseph's — Phoenix, Arizona, United States (RECRUITING)
- Mayo Clinic Hospital in Arizona — Phoenix, Arizona, United States (RECRUITING)
- Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States (RECRUITING)
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas, United States (RECRUITING)
- CARTI Cancer Center — Little Rock, Arkansas, United States (RECRUITING)
- Kaiser Permanente-Deer Valley Medical Center — Antioch, California, United States (ACTIVE_NOT_RECRUITING)
- Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California, United States (RECRUITING)
- Mercy Cancer Center - Carmichael — Carmichael, California, United States (RECRUITING)
- Mercy San Juan Medical Center — Carmichael, California, United States (RECRUITING)
- Enloe Medical Center — Chico, California, United States (RECRUITING)
- Kaiser Permanente Dublin — Dublin, California, United States (ACTIVE_NOT_RECRUITING)
- Mercy Cancer Center - Elk Grove — Elk Grove, California, United States (RECRUITING)
- Kaiser Permanente-Fremont — Fremont, California, United States (ACTIVE_NOT_RECRUITING)
- Fresno Cancer Center — Fresno, California, United States (ACTIVE_NOT_RECRUITING)
- Kaiser Permanente Fresno Orchard Plaza — Fresno, California, United States (ACTIVE_NOT_RECRUITING)
- Kaiser Permanente-Fresno — Fresno, California, United States (ACTIVE_NOT_RECRUITING)
- UC San Diego Moores Cancer Center — La Jolla, California, United States (RECRUITING)
- Fremont - Rideout Cancer Center — Marysville, California, United States (RECRUITING)
- Mercy Cancer Center — Merced, California, United States (RECRUITING)
- Kaiser Permanente- Modesto MOB II — Modesto, California, United States (ACTIVE_NOT_RECRUITING)
- Kaiser Permanente-Modesto — Modesto, California, United States (ACTIVE_NOT_RECRUITING)
- Kaiser Permanente Oakland-Broadway — Oakland, California, United States (ACTIVE_NOT_RECRUITING)
- Kaiser Permanente-Oakland — Oakland, California, United States (ACTIVE_NOT_RECRUITING)
- Kaiser Permanente-Rancho Cordova Cancer Center — Rancho Cordova, California, United States (ACTIVE_NOT_RECRUITING)
- Kaiser Permanente- Marshall Medical Offices — Redwood City, California, United States (ACTIVE_NOT_RECRUITING)
- Kaiser Permanente-Richmond — Richmond, California, United States (ACTIVE_NOT_RECRUITING)
- Mercy Cancer Center - Rocklin — Rocklin, California, United States (RECRUITING)
- Rohnert Park Cancer Center — Rohnert Park, California, United States (ACTIVE_NOT_RECRUITING)
- Kaiser Permanente-Roseville — Roseville, California, United States (ACTIVE_NOT_RECRUITING)
- The Permanente Medical Group-Roseville Radiation Oncology — Roseville, California, United States (ACTIVE_NOT_RECRUITING)
- Kaiser Permanente Downtown Commons — Sacramento, California, United States (ACTIVE_NOT_RECRUITING)
- Mercy Cancer Center - Sacramento — Sacramento, California, United States (RECRUITING)
- University of California Davis Comprehensive Cancer Center — Sacramento, California, United States (RECRUITING)
- Kaiser Permanente-South Sacramento — Sacramento, California, United States (ACTIVE_NOT_RECRUITING)
- South Sacramento Cancer Center — Sacramento, California, United States (ACTIVE_NOT_RECRUITING)
- Kaiser Permanente-San Francisco — San Francisco, California, United States (ACTIVE_NOT_RECRUITING)
- Kaiser Permanente-Santa Teresa-San Jose — San Jose, California, United States (ACTIVE_NOT_RECRUITING)
- Kaiser Permanente San Leandro — San Leandro, California, United States (ACTIVE_NOT_RECRUITING)
- Pacific Central Coast Health Center-San Luis Obispo — San Luis Obispo, California, United States (RECRUITING)
- Kaiser San Rafael-Gallinas — San Rafael, California, United States (ACTIVE_NOT_RECRUITING)
- Kaiser Permanente Medical Center - Santa Clara — Santa Clara, California, United States (ACTIVE_NOT_RECRUITING)
- Mission Hope Medical Oncology - Santa Maria — Santa Maria, California, United States (RECRUITING)
- Kaiser Permanente-Santa Rosa — Santa Rosa, California, United States (ACTIVE_NOT_RECRUITING)
- Kaiser Permanente Cancer Treatment Center — South San Francisco, California, United States (ACTIVE_NOT_RECRUITING)
- Kaiser Permanente-South San Francisco — South San Francisco, California, United States (ACTIVE_NOT_RECRUITING)
- Saint Joseph's Medical Center — Stockton, California, United States (RECRUITING)
- Kaiser Permanente-Stockton — Stockton, California, United States (ACTIVE_NOT_RECRUITING)
- Kaiser Permanente Medical Center-Vacaville — Vacaville, California, United States (ACTIVE_NOT_RECRUITING)
- Kaiser Permanente-Vallejo — Vallejo, California, United States (ACTIVE_NOT_RECRUITING)
+327 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Kathryn Kelley, MPH
- Email: kathryn.kelley@bsd.uchicago.edu
- Phone: (773) 702-9171
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Resectable Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8