Atezolizumab + Chemoradiation for Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+563 other locations

Overseen ByKristin A Higgins

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults with a confirmed diagnosis of limited stage small cell lung cancer. Participants must have had one cycle of specific chemotherapy, be in good physical condition (ECOG 0-2), and have proper organ function. Pregnant women, those with certain medical conditions or previous treatments like immunotherapy, and individuals not using contraception are excluded.

Inclusion Criteria

I am 18 years old or older.

I was mostly active and able to care for myself within the last month.

I have completed one cycle of platinum/etoposide chemotherapy.

My cancer was measurable before starting specific chemotherapy.

I've had a CT scan of my chest and abdomen or an MRI of my abdomen with contrast in the last 60 days.

Exclusion Criteria

I've had radiation to my chest area that overlaps with new treatment areas.

I have an active hepatitis B or C infection.

I am not pregnant and willing to use contraception if of childbearing potential.

I have received an organ from another person.

I have a condition that weakens my immune system.

I have a serious lung condition affecting the tissue and space around the air sacs.

I have had more than one round of platinum-based chemotherapy for small cell lung cancer.

I had surgery to remove small cell lung cancer.

I have or had inflammatory bowel disease.

I take more than 10 mg of prednisone daily for my COPD.

I have previously received atezolizumab or another immunotherapy.

My cancer has spread to other parts of my body.

I have active tuberculosis.

I have a significant liver condition.

I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 3 months.

I have an autoimmune disease.

Participant Groups

The study is examining the effectiveness of adding Atezolizumab to standard chemoradiation therapy for treating small cell lung cancer. It compares outcomes between patients receiving usual treatment alone versus those also getting this new immunotherapy drug.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (chemotherapy, radiation therapy, atezolizumab)Experimental Treatment9 Interventions

Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.

Group II: Arm I (chemotherapy, radiation therapy)Active Control8 Interventions

Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.

3-Dimensional Conformal Radiation Therapy is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

🇺🇸 Approved in United States as 3D-CRT for: