This phase II/III trial studies how well chemotherapy and radiation therapy (chemoradiation), with or without atezolizumab, works in treating patients with limited-stage small cell lung cancer. Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, 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. Radiation therapy uses high energy X-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving chemoradiation with or without atezolizumab may work better in treating patients with limited stage small cell lung cancer.
Accepting new patients
The primary objectives of this study are to determine:
To be determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Will compare the distributions of PFS between treatment arms using a one-sided stratified log-rank test in all randomized eligible patients. The rates at various timepoints (e.g., every six months after randomization) and medians of PFS for each arm will be estimated using the Kaplan-Meier method (1958). The associated 95 percent confidence interval (CI) will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Results from an unstratified analysis will also be provided.
The primary hypotheses for the phase II and III portions will be evaluated by comparing arm 1 to arm 2 based on PFS (phase II) and OS (phase III) using a stratified log-rank test. Hazard ratios will be estimated using a stratified Cox regression model. Event rates over time will be estimated within each treatment group using the Kaplan-Meier method.
Note: This is only a partial list of eligibility criteria.
Including patients who:
Excluding patients who:
Accepting new patients
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Principal Investigator(s)