Trial · NCT03811002
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)
NCT03811002, Phase 3, Active not recruiting, National Cancer Institute (NCI); results first posted 2025-06-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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). Trials, record NCT03811002. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03811002
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 544 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- 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
- First posted
- 2019-01-22
- Last updated
- 2026-08-27
- Results first posted
- 2025-06-12
- Limitations and caveats
The second planned interim efficacy analysis met the early stopping rule for futility. Per the protocol, the second planned interim analysis occurred after 222 deaths had been reported across both arms combined. The final analysis would have otherwise taken place after 315 deaths.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Randomization to date of death due or last follow-up. Median follow-up at the time of analysis was 23.8 months. | Survival rates and median survival time are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis. |
| Secondary | Progression Free Survival (PFS) | From randomization to progression or death due to any cause, whichever occurs first, or last tumor assessment if alive. MMedian follow-up at the time of analysis was 23.8 months. | PFS failure event is defined as progressive disease (PD) determined by investigator per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause. PD is defined as at least a 20% increase in the sum of longest diameters of target lesions, and an absolute increase of at least 5 mm. The appearance of any new lesions is also considered progression. PFS rates and median PFS time are estimated using the Kaplan-Meier method, censoring participants alive without progression at the date of their last evaluable radiographic tumor assessment. |
| Secondary | Number of Participants by Highest Grade Adverse Event Reported | Randomization to last follow-up. Median follow-up at the time of analysis was 23.8 months. | Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. |
| Secondary | Percentage of Participants With Confirmed Objective Response (Objective Response Rate (ORR)) | Randomization to last radiographic tumor assessment. Median follow-up at the time of analysis was 23.8 months. | Objective response rate (ORR) is defined as the proportion of subjects whose best overall response (BOR) is a confirmed complete or partial response as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 on two consecutive occasions ≥4 weeks apart. |
| Secondary | Percentage of Participants With Local Progression | From randomization to local progression, other progression, or death, whichever occurs first, or last tumor assessment if alive. Median follow-up at the time of analysis was 23.8 months. 1-, 2-, and 3-year rates are reported. | Local progression is defined as intrathoracic tumor progression (failure in the lobe of the primary tumor or mediastinal lymph nodes) by RECIST 1.1 criteria determined by the investigator. Local progression rates are estimated by the cumulative incidence method, treating non-local progression (i.e., distant metastasis or failure in a different lung) and death without local progression as competing risks, and otherwise censoring participants alive at last tumor assessment. Treatment effect comparisons will utilize a cause-specific hazard function in which competing risks are censored. |
| Secondary | Distant Metastases-free Survival (DMFS) | Randomization to DMFS event or local progression, whichever occurs first, or last tumor assessment if alive. Median follow-up at the time of analysis was 23.8 months. | DMFS failure event is defined as first date of documented distant metastases (or failures in a different lung lobe) or death due to any cause, whichever occurs first. Participants with local progression prior to such an event are censored on the date of local progression. Participants with no post-baseline tumor assessment and alive at last follow-up are censored on the date of randomization. Participants alive without distant metastasis, failures in a different lung lobe, or local progression are censored on the date of their last evaluable radiographic tumor assessment. DMFS rates and median DMFS time are estimated using the Kaplan-Meier method. |
| Secondary | Percent of Participants With Deterioration in Functional Assessment of Cancer Therapy-Trial Outcome Index (FACT-TOI) | Baseline and 15 months after completion of chemoradiation (approximately 18 months after randomization) | 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. |
| Secondary | Quality-adjusted Survival Months | Baseline to death, last follow-up or two years, whichever occurs first. | Quality-adjusted survival is calculated as the sum of weighted time intervals. Weight is the EuroQol 5-dimensional 5-level (EQ-5d-5L) index score, which measures health-related quality of life and ranges from 0 (death) to 1 (full health). |
| Secondary | Change From Baseline in the 7 Item Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Score | Baseline and 15 months after completion of chemoradiation (approximately 18 months after randomization) | The PROMIS fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible scores range from 29.4 to 83.2, with higher scores indicating more fatigue. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased fatigue. |
| Secondary | Molecular Subtyping | Up to 5 years |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | Randomization to date of death due or last follow-up. Median follow-up at the time of analysis was 23.8 months. | Intent-to-treat population | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | From randomization to progression or death due to any cause, whichever occurs first, or last tumor assessment if alive. MMedian follow-up at the time of analysis was 23.8 months. | Intent-to-treat population | months | MEDIAN |
| SECONDARY | Number of Participants by Highest Grade Adverse Event Reported | Randomization to last follow-up. Median follow-up at the time of analysis was 23.8 months. | Adverse event population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Confirmed Objective Response (Objective Response Rate (ORR)) | Randomization to last radiographic tumor assessment. Median follow-up at the time of analysis was 23.8 months. | Intent-to-treat population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Local Progression | From randomization to local progression, other progression, or death, whichever occurs first, or last tumor assessment if alive. Median follow-up at the time of analysis was 23.8 months. 1-, 2-, and 3-year rates are reported. | Intent-to-treat population | percentage of participants | NUMBER |
| SECONDARY | Distant Metastases-free Survival (DMFS) | Randomization to DMFS event or local progression, whichever occurs first, or last tumor assessment if alive. Median follow-up at the time of analysis was 23.8 months. | Intent-to-treat population | months | MEDIAN |
| SECONDARY | Percent of Participants With Deterioration in Functional Assessment of Cancer Therapy-Trial Outcome Index (FACT-TOI) | Baseline and 15 months after completion of chemoradiation (approximately 18 months after randomization) | Intent-to-treat participants with FACT-TOI at baseline and 15 months after completion of chemoradiation (approximately 18 months after randomization). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Quality-adjusted Survival Months | Baseline to death, last follow-up or two years, whichever occurs first. | Eligible participants with baseline EQ-5D-5L index score and at least one follow-up EQ-5D-5L index score. | months | MEAN |
| SECONDARY | Change From Baseline in the 7 Item Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Score | Baseline and 15 months after completion of chemoradiation (approximately 18 months after randomization) | Intent-to-treat participants with score at baseline and 15 months after completion of chemoradiation (approximately 18 months after randomization). | score on a scale | MEAN |
| SECONDARY | Molecular Subtyping | Up to 5 years |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group77
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Arm I (Chemotherapy, Radiation Therapy) | 36.1 | 95% Confidence Interval 28.1 to 42.5 | months | |
| Overall Survival | Arm II (Chemotherapy, Radiation Therapy, Atezolizumab) | 31.1 | 95% Confidence Interval 28.5 to 44.7 | months | |
| Progression Free Survival (PFS) | Arm I (Chemotherapy, Radiation Therapy) | 11.4 | 95% Confidence Interval 10.3 to 13.2 | months | |
| Progression Free Survival (PFS) | Arm II (Chemotherapy, Radiation Therapy, Atezolizumab) | 12.1 | 95% Confidence Interval 10.9 to 15.2 | months | |
| Number of Participants by Highest Grade Adverse Event Reported | Arm I (Chemotherapy, Radiation Therapy) | Overall / None reported | 4 | Participants | |
| Number of Participants by Highest Grade Adverse Event Reported | Arm II (Chemotherapy, Radiation Therapy, Atezolizumab) | Overall / None reported | 0 | Participants | |
| Number of Participants by Highest Grade Adverse Event Reported | Arm I (Chemotherapy, Radiation Therapy) | Overall / Grade 1 | 3 | Participants | |
| Number of Participants by Highest Grade Adverse Event Reported | Arm II (Chemotherapy, Radiation Therapy, Atezolizumab) | Overall / Grade 1 | 0 | Participants | |
| Number of Participants by Highest Grade Adverse Event Reported | Arm I (Chemotherapy, Radiation Therapy) | Overall / Grade 2 | 8 | Participants | |
| Number of Participants by Highest Grade Adverse Event Reported | Arm II (Chemotherapy, Radiation Therapy, Atezolizumab) | Overall / Grade 2 | 9 | Participants |
1 to 10 of 77Source ClinicalTrials.gov
See all 77 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Chemotherapy, Radiation Therapy) | 270 | |
| Overall Study | STARTED | Arm II (Chemotherapy, Radiation Therapy, Atezolizumab) | 274 | |
| Overall Study | Adverse Event Population | Arm I (Chemotherapy, Radiation Therapy) | 257 | |
| Overall Study | Adverse Event Population | Arm II (Chemotherapy, Radiation Therapy, Atezolizumab) | 264 | |
| Overall Study | Intent-to-treat (ITT) | Arm I (Chemotherapy, Radiation Therapy) | 270 | |
| Overall Study | Intent-to-treat (ITT) | Arm II (Chemotherapy, Radiation Therapy, Atezolizumab) | 274 | |
| Overall Study | COMPLETED | Arm I (Chemotherapy, Radiation Therapy) | 270 | |
| Overall Study | COMPLETED | Arm II (Chemotherapy, Radiation Therapy, Atezolizumab) | 274 | |
| Overall Study | NOT COMPLETED | Arm I (Chemotherapy, Radiation Therapy) | 0 | |
| Overall Study | NOT COMPLETED | Arm II (Chemotherapy, Radiation Therapy, Atezolizumab) | 0 |
Source ClinicalTrials.gov
Adverse events502
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Arm I (Chemotherapy, Radiation Therapy) | 210 | 257 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Chemotherapy, Radiation Therapy, Atezolizumab) | 220 | 264 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm I (Chemotherapy, Radiation Therapy) | 18 | 257 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm II (Chemotherapy, Radiation Therapy, Atezolizumab) | 8 | 264 | |
| other | Palpitations | Cardiac disorders | Arm I (Chemotherapy, Radiation Therapy) | 12 | 257 | |
| other | Palpitations | Cardiac disorders | Arm II (Chemotherapy, Radiation Therapy, Atezolizumab) | 24 | 264 | |
| other | Sinus tachycardia | Cardiac disorders | Arm I (Chemotherapy, Radiation Therapy) | 35 | 257 | |
| other | Sinus tachycardia | Cardiac disorders | Arm II (Chemotherapy, Radiation Therapy, Atezolizumab) | 41 | 264 | |
| other | Tinnitus | Ear and labyrinth disorders | Arm I (Chemotherapy, Radiation Therapy) | 43 | 257 | |
| other | Tinnitus | Ear and labyrinth disorders | Arm II (Chemotherapy, Radiation Therapy, Atezolizumab) | 26 | 264 |
1 to 10 of 502Source ClinicalTrials.gov
See all 502 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Chemotherapy, Radiation Therapy) | 120 | 270 |
| Total, all-cause mortality | Arm II (Chemotherapy, Radiation Therapy, Atezolizumab) | 132 | 274 |
| Total, other adverse events | Arm I (Chemotherapy, Radiation Therapy) | 253 | 257 |
| Total, other adverse events | Arm II (Chemotherapy, Radiation Therapy, Atezolizumab) | 263 | 264 |
| Total, serious adverse events | Arm I (Chemotherapy, Radiation Therapy) | 106 | 257 |
| Total, serious adverse events | Arm II (Chemotherapy, Radiation Therapy, Atezolizumab) | 159 | 264 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
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 |
| Arm I (Chemotherapy, Radiation Therapy) vs Arm II (Chemotherapy, Radiation Therapy, Atezolizumab): deaths from any cause | Trial comparisons |
| Arm I (Chemotherapy, Radiation Therapy) vs Arm II (Chemotherapy, Radiation Therapy, Atezolizumab): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03811002
GET https://conductscience.org/api/trials/v1/NCT03811002/results?page=2