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)

Conditions

• Limited Stage Lung Small Cell Carcinoma
• Stage I Lung Cancer AJCC v8
• Stage II Lung Cancer AJCC v8
• Stage III Lung Cancer AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 3-Dimensional Conformal Radiation Therapy — RADIATION
  Undergo 3D-CRT
• Atezolizumab — DRUG
  Given IV
• Biospecimen Collection — PROCEDURE
  Correlative studies
• Carboplatin — DRUG
  Given IV
• Cisplatin — DRUG
  Given IV
• Etoposide — DRUG
  Given IV
• Intensity-Modulated Radiation Therapy — RADIATION
  Undergo IMRT
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Jul 26, 2019

Status verified

Feb 2026

Primary completion

Apr 21, 2024

Completion

Feb 21, 2029

Study Design

Enrollment

544 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (chemotherapy, radiation therapy)
  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.
• Experimental: Arm II (chemotherapy, radiation therapy, atezolizumab)
  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.

Primary Outcome Measure

Overall Survival [ Time Frame: Randomization to date of death due or last follow-up. Median follow-up at the time of analysis was 23.8 months. ]

Locations (533)

Related coverage on Hipa.ai

• Atezolizumab Plus Chemoradiation Lacks OS Benefit in Limited Stage SCLC
  Atezolizumab · Jun 12, 2025 · ClinicalTrials.gov
• Atezolizumab Phase 3 for LS-SCLC: No Significant OS or PFS Improvement
  Atezolizumab · Apr 21, 2024 · ClinicalTrials.gov

Find similar trials in Birmingham, AL

Related Studies

• Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer
  PHASE1 · Recruiting · M.D. Anderson Cancer Center · Houston, Texas
• Dyadic Yoga Intervention in Improving Physical Performance and Quality of Life in Patients With Stage I-IV Non-small Cell Lung or Esophageal Cancer Undergoing Radiotherapy and Their Caregivers
  Recruiting · M.D. Anderson Cancer Center · Houston, Texas
• Respiratory Muscle Training Before Surgery in Preventing Lung Complications in Patients With Stage I-IIIB Lung Cancer
  PHASE2 · Recruiting · Roswell Park Cancer Institute · Buffalo, New York
• Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])
  PHASE3 · Recruiting · National Cancer Institute (NCI) · Anchorage, Alaska