Testing the Addition of a New Immunotherapy Drug, Atezolizumab (MPDL3280A), to the Usual Chemorad… (NCT03811002) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Testing the Addition of a New Immunotherapy Drug, Atezolizumab (MPDL3280A), to the Usual Chemoradiation (CRT) Therapy Treatment for Limited Stage Small Cell Lung Cancer (LS-SCLC)
United States, Japan544 participantsStarted 2019-07-26
Plain-language summary
This phase 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pathologically (histologically or cytologically) proven diagnosis of limited stage small cell lung cancer (Stage Tx, T1-T4, N0-3, M0, American Joint Committee on Cancer \[AJCC\] staging, 8th edition \[Ed.\]), within 60 days prior to registration
* Patients must have received one cycle of platinum/etoposide chemotherapy pre-registration (prior to study entry). Study registration must be within 21 days from day 1 of the pre-registration cycle of chemotherapy.
* Patients must have had measurable disease (per Response Evaluation Criteria in Solid Tumors \[RECIST\], version 1.1) prior to the required pre-registration cycle of platinum/etoposide chemotherapy
* Minimal staging requirements include:
* History/physical examination within 30 days prior to registration
* Positron emission tomography (PET)/computed tomography (CT) scan for staging within 60 days prior to registration
* CT chest and CT abdomen with IV contrast (unless contraindicated based on kidney function) within 60 days prior to registration; magnetic resonance imaging (MRI) abdomen with IV contrast allowed in place of CT abdomen
* Note: If contrast allergy exists, premedication per institutional guidelines should be performed prior to obtaining CT with contrast. The only exception to this is a documented life-threatening allergy
* MRI scan of the brain with contrast (preferred) or CT scan of the brain with contrast (allowable if there is a contraindication with MRI with contrast) …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Phase 3 and is actively measuring overall survival — what does that tell us about how much is already known about whether adding atezolizumab to chemoradiation is safe and beneficial for limited stage small cell lung cancer?
2Since this trial is no longer recruiting new patients, is there any way I could still access atezolizumab through a compassionate use program, expanded access, or another related trial that might be open?
3How does adding an immunotherapy drug like atezolizumab to standard chemoradiation compare to just doing chemoradiation alone — what are the potential additional risks or side effects I should be aware of?
4Given that my cancer is classified as limited stage, which can range from Stage I to Stage III, how does my specific stage affect whether this kind of combined approach might or might not make sense for my situation?
5Before considering an immunotherapy combination like this, should I first go through standard chemoradiation on its own, and what would help us decide whether adding something like atezolizumab is the right next step for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Survival
Timeframe: Randomization to date of death due or last follow-up. Median follow-up at the time of analysis was 23.8 months.