Study on Atezolizumab Compared to Best Supportive Care After Chemotherapy in Lung Cancer Patients [IMpower010]
Sponsor: Hoffmann-La Roche
ClinicalTrials ID:NCT02486718
This clinical trial is comparing the effects of the drug atezolizumab to the best supportive care in patients with non-small cell lung cancer (NSCLC) who have already had surgery and chemotherapy. The study aims to see which treatment helps patients live longer without the cancer returning.
Patient Parameters
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Program Overview
This study is looking at how well the drug atezolizumab works compared to the best supportive care in patients with Stage IB to Stage IIIA non-small cell lung cancer (NSCLC) after they have had surgery and chemotherapy. The main goals are to see if atezolizumab can help patients live longer without the cancer coming back and to compare overall survival rates between the two groups. Participants will be randomly assigned to receive either atezolizumab for 16 cycles or the best supportive care after completing up to 4 cycles of chemotherapy.
Eligibility Criteria
Inclusion Criteria
- Must be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have a confirmed diagnosis of Stage IB-IIIA non-small cell lung cancer (NSCLC) based on specific medical criteria.
- Must have had complete surgical removal of the lung cancer 4 to 12 weeks before joining the study and be fully recovered from surgery.
- Must have had specific lymph node sampling during surgery unless certain conditions are met.
- Eligible to receive a cisplatin-based chemotherapy regimen.
- Must have adequate blood cell counts and organ function.
- Women who are not postmenopausal or surgically sterile must have a negative pregnancy test before starting chemotherapy or atezolizumab.
Exclusion Criteria
- Have any illness or condition that may interfere with understanding or following the study procedures.
- Pregnant or breastfeeding women.
- Have had prior chemotherapy for early-stage cancer within the last 5 years, unless approved by the study team.
- Have had hormonal or radiation therapy for cancer within the last 5 years.
- Have received any other investigational treatment within 28 days before joining the study.
- Have hearing impairment or known allergies to the study drugs.
- Have had previous treatments with certain immune therapies.
- Have had other cancers within the last 5 years, except for certain non-threatening types.
- Have severe allergies to certain antibodies or proteins.
- Have autoimmune diseases or certain infections like HIV, hepatitis B, or C.
- Have significant heart or lung diseases.
- Have had a bone marrow or organ transplant.
- Have any other condition that may pose a risk during the study.
- Have known PD-L1 expression status from other studies.
- Have signs of infection or have taken antibiotics recently.
- Have had major surgery recently or need major surgery during the study.
- Have received a live vaccine recently or need one during the study.
- Have taken certain immune-stimulating or suppressing medications recently.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Highlands Oncology Group | 72703 | Fayetteville | Arkansas |
| California Cancer Associates for Research & Excellence, Inc. | 92024 | Encinitas | California |
| Compassionate Cancer Care Medical Group, Inc | 92708 | Fountain Valley | California |
| University of California Los Angeles | 90024 | Los Angeles | California |
| Kaiser Permanente | 94589 | Vallejo | California |
| Kaiser Permanente - Walnut Creek | 94596 | Walnut Creek | California |
| Eastern Connecticut Hematology and Oncology Associates | 06360 | Norwich | Connecticut |
| Lynn Cancer Institute - West | 33486 | Boca Raton | Florida |
| University of Miami School of Medicine - Sylvester at Deerfield | 33442 | Deerfield Beach | Florida |
| SCRI Florida Cancer Specialists North | 33705 | St. Petersburg | Florida |
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