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Comparison · NCT03811002-720cc045

Arm I (Chemotherapy, Radiation Therapy) vs Arm II (Chemotherapy, Radiation Therapy, Atezolizumab): Percent of Participants With Deterioration in Functional Assessment of Cancer Therapy-Trial Outcome Index (FACT-TOI)

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Arm I (Chemotherapy, Radiation Therapy) vs Arm II (Chemotherapy, Radiation Therapy, Atezolizumab): Percent of Participants With Deterioration in Functional Assessment of Cancer Therapy-Trial Outcome Index (FACT-TOI). Trial comparisons, record NCT03811002-720cc045. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03811002-720cc045

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.3240.2410.419wilson
Risk in group 20.3550.2710.447wilson
Risk difference, group 1 minus group 2-0.031-0.1560.0958newcombe hybrid score
Risk ratio, group 1 over group 20.9130.6261.33log
Odds ratio, group 1 over group 20.8710.4921.54log
Number needed to treat, for one fewer participant with the outcome on Arm I (Chemotherapy, Radiation Therapy) than on Arm II (Chemotherapy, Radiation Therapy, Atezolizumab)32.2from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Arm 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.
33102OG000
Group 2Arm 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.
39110OG001

Outcome

Type
SECONDARY
Title
Percent of Participants With Deterioration in Functional Assessment of Cancer Therapy-Trial Outcome Index (FACT-TOI)
Description
FACT-TOI is a measure of 21 items that sums the functional well-being (FWB), physical well-being (PWB), and the lung cancer subscale (LCS) of the Functional Assessment of Cancer Therapy - Lung (FACT-L) quality of life (QOL) instrument. The FACT-TOI total score ranges from 0 to 84 with higher scores indicating better quality of life and functioning. Clinically meaningful decline is defined as a decrease from baseline of at least 5 points.
Time frame
Baseline and 15 months after completion of chemoradiation (approximately 18 months after randomization)
Population
Intent-to-treat participants with FACT-TOI at baseline and 15 months after completion of chemoradiation (approximately 18 months after randomization).

Source ClinicalTrials.gov

Trial

Title
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)
NCT number
NCT03811002
Phases
PHASE3
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
Interventions
3-Dimensional Conformal Radiation Therapy, Atezolizumab, Biospecimen Collection, Carboplatin, Cisplatin, Etoposide, Intensity-Modulated Radiation Therapy, Quality-of-Life Assessment, Questionnaire Administration
Lead sponsor
National Cancer Institute (NCI)
Results first posted
2025-06-12

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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