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Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non-small Cell Lung Cancer

StatusActive, Not Recruiting
PhasePhase 3
Started2024-12-11
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 97% 1100 → 37 participants
See other at-risk trials from Alliance for Clinical Trials in Oncology

Amendment history

2026-09-01
minor
Study Status, Contacts/Locations v20
Trial sites expanded: 411 → 415 locations
2026-08-20
critical
Study Status, Study Design, Contacts/Locations v19
Enrollment closed, study ongoing
Enrollment reduced: 1100 → 37 participants
Trial sites reduced: 415 → 411 locations
2026-08-04
minor
Study Status, Contacts/Locations v18
Trial sites expanded: 382 → 415 locations
2026-07-01
minor
Study Status, Contacts/Locations v17
Trial sites expanded: 378 → 382 locations
2026-06-01
minor
Study Status, Contacts/Locations v16
Study sites377→378
2026-05-07
minor
Study Status, Contacts/Locations v15
Study sitesdetails revised at 38 of 377 sites
2026-04-06
minor
Study Status, Contacts/Locations v14
Trial sites expanded: 370 → 377 locations
2026-03-02
minor
Study Status, Contacts/Locations v13
Study sites369→370
2026-02-03
minor
Study Status, Contacts/Locations v12
Study sites367→369
2026-01-06
minor
Study Status, Contacts/Locations v11
Study sites357→367
2025-12-08
minor
Study Status, Contacts/Locations v10
Study sites349→357
2025-11-04
minor
Study Status, Contacts/Locations v9
Study sites346→349
2025-10-07
minor
Study Status, Contacts/Locations v8
Study sites343→346
2025-09-05
minor
Study Status, Contacts/Locations v7
Study sites328→343
2025-06-24
minor
Study Status, Oversight, Contacts/Locations, IPDSharing v6
Study sites227→328
2025-05-22
minor
Study Status, Oversight, Contacts/Locations, IPDSharing v5
Re-verified, no change to tracked fields
2025-03-28
minor
Study Status, Contacts/Locations v4
Study sites18→227
2025-01-18
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-05-30→confirmed 2024-12-11
Study sitesdetails revised at 18 of 18 sites
2025-01-02
minor
Study Status, Contacts/Locations v2
Study sites0→18
2024-12-24
minor
Study Identification, Study Status v1
Re-verified, no change to tracked fields
2024-10-07
minor
Original filing
This phase III trial compares standard therapy given after surgery (adjuvant) to standard therapy given before and after surgery (perioperative) in treating patients with stage II-IIIB non-small cell lung cancer (NSCLC) that can be removed by surgery (resectable). The usual approach for patients with resectable NSCLC is chemotherapy and/or immunotherapy before surgery, after surgery, or both before and after surgery. This study is being done to find out which approach is better at treating patients with lung cancer. Treatment will be administered according to the current standard of care at the time of enrollment. Chemotherapy options may include cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and vinorelbine at standard doses according to the treating physician. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Other chemotherapy drugs, such as vinorelbine, 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 . Immunotherapy with monoclonal antibodies, such as nivolumab, pembrolizumab, and atezolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with chemotherapy and immunotherapy prior to surgery and continuing treatment after surgery may be a more effective treatment option than adjuvant therapy alone in patients with stage II-IIIB resectable NSCLC.
Trial Details
NCT Number NCT06632327
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
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
Enrollment 37 participants
Start Date 2024-12-11
Primary Completion 2029-04-30 (estimated)
Study Completion 2030-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-02