TriangleNCT02763579 · CITED IN SOURCE DOCUMENTS
A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2023-07-28
This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study was designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC. Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin + etoposide or placebo + carboplatin + etoposide on 21-day cycles for four cycles in the induction phase followed by maintenance with atezolizumab or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1 in the Global Population
Duration of Overall Survival (OS) in the Global Population
Percentage of Participants With Objective Response Rate (ORR) as Assessed by the Investigator Using RECIST v1.1 in the Global Population
Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1 in the Global Population
PFS Rate at 6 Months and at 1 Year in Global Population
OS Rate at 1 Year and 2 Years in the Global Population
Time to Deterioration (TTD) Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30) and Supplemental Lung Cancer Module (QLQ-LC13) in the Global Population
Percentage of Participants With at Least One Adverse Event in the Global Population
Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab in the Global Population
Maximum Observed Serum Concentration (Cmax) of Atezolizumab in the Global Population
Minimum Observed Serum Concentration (Cmin) of Atezolizumab in the Global Population
Plasma Concentration of Carboplatin in the Global Population
Plasma Concentration of Etoposide in the Global Population
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system) * No prior systemic treatment for ES-SCLC * Eastern Cooperative Oncology Group performance status of 0 or 1 * Measurable disease, as defined by RECIST v1.1 * Adequate hematologic and end organ function * Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC Exclusion Criteria: * Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation * Malignancies other than SCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome * Pregnant or lactating women * History of autoimmune disease * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted. * Positive test result for human immunodeficiency virus (HIV) * Active hepatitis B or hepatitis C * Severe infections at the time of randomization * Significant cardiovascular disease * Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1 (PD-1), and anti-PD-L1 therapeutic antibody * History of severe (or known) hypersensitivity to chimeric or humanized antibodies or fusion proteins or any component of atezolizumab formulation.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
- intervention Names
- Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
- Drug: Carboplatin
- Drug: Etoposide
- label
- Atezolizumab + Carboplatin + Etoposide
- type
- EXPERIMENTAL
- description
- Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
- intervention Names
- Drug: Carboplatin
- Drug: Etoposide
- Drug: Placebo
- label
- Placebo + Carboplatin + Etoposide
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Atezolizumab + Carboplatin + Etoposide
- description
- Atezolizumab intravenous infusion was administered at a dose of 1200 mg on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4) and maintenance phase (Cycle 5 onward).
- name
- Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
- other Names
- MPDL3280A, RO5541267, Tecentriq
- type
- DRUG
- arm Group Labels
- Atezolizumab + Carboplatin + Etoposide
- Placebo + Carboplatin + Etoposide
- description
- Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).
- name
- Carboplatin
- type
- DRUG
- arm Group Labels
- Atezolizumab + Carboplatin + Etoposide
- Placebo + Carboplatin + Etoposide
- description
- Etoposide intravenous infusion was administered at a dose of 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle during the induction phase (Cycles 1-4).
- name
- Etoposide
- type
- DRUG
- arm Group Labels
- Placebo + Carboplatin + Etoposide
- description
- Placebo intravenous infusion was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4) and maintenance phase (Cycle 5 onward).
- name
- Placebo
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- DOUBLE
- who Masked
- PARTICIPANT
- INVESTIGATOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 503
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least 20% increase in the sum of the longest diameter of target lesions compared to baseline, or unequivocal progression in non-target lesion(s), or the appearance of new lesion(s).
- measure
- Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1 in the Global Population
- time Frame
- Baseline until PD or death, whichever occurs first (up to approximately 23 months)
- description
- OS is defined as the time from randomization to death from any cause.
- measure
- Duration of Overall Survival (OS) in the Global Population
- time Frame
- Baseline until death from any cause (up to approximately 23 months)
- secondary Outcomes
- description
- Objective response (OR) is defined as complete response (CR) or partial response (PR) as determined by the investigator according to RECIST v1.1.
- measure
- Percentage of Participants With Objective Response Rate (ORR) as Assessed by the Investigator Using RECIST v1.1 in the Global Population
- time Frame
- Baseline until partial response (PR) or complete response (CR), whichever occurs first (up to approximately 23 months)
- description
- DOR is defined as the time interval from first occurrence of a documented objective response to the time of disease progression as determined by the investigator using RECIST v1.1 or death from any cause, whichever comes first.
- measure
- Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1 in the Global Population
- time Frame
- First occurrence of PR or CR until PD or death, whichever occurs first (up to approximately 23 months)
- description
- PFS rates at 6 months and at 1 year is defined as the proportion of participants who are alive without disease progression 6 months and 1 year after randomization, respectively.
- measure
- PFS Rate at 6 Months and at 1 Year in Global Population
- time Frame
- 6 months, 1 year
- description
- OS rates at 1 and 2 years is defined as the proportion of participants who are alive 1 year and 2 years after randomization, respectively.
- measure
- OS Rate at 1 Year and 2 Years in the Global Population
- time Frame
- 1 year, 2 years
- description
- TTD according to the EORTC QLQ-C30 and EORTC QLQ-LC13 measures were evaluated in each of the following linearly transformed symptom scores: cough, dyspnea (single item), dyspnea (multi-item subscale), chest pain, or arm/shoulder pain. The linear transformation gives each individual symptom subscale a possible score of 0 to 100. For the symptom to be considered "deteriorated," a score increase of ≥10 points above baseline must be held for at least two consecutive assessments or an initial score increase of ≥10 points is followed by death within 3 weeks from the last assessment. A ≥ 10-point change in the symptoms subscale score is perceived by participants as clinically significant.
- measure
- Time to Deterioration (TTD) Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30) and Supplemental Lung Cancer Module (QLQ-LC13) in the Global Population
- time Frame
- Baseline until deterioration per symptom subscale (up to approximately 23 months)
- description
- The percentage of participants with at least one adverse event in the global population.
- measure
- Percentage of Participants With at Least One Adverse Event in the Global Population
- time Frame
- Baseline until up to 90 days after end of treatment (up to approximately 49 months)
- description
- The baseline prevalence and post-baseline incidence of ADAs against atezolizumab.
- measure
- Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab in the Global Population
- time Frame
- Predose (0 hours [H]) on Day (D) 1 of Cycles (C) 1, 2, 3, 4, 8, 16, and every 8 cycles (Q8C) thereafter (cycle = 21 days) until treatment discontinuation (up to 23 months) and 120 days after last dose (up to approximately 23 months overall)
- description
- Atezolizumab maximum observed plasma concentration (Cmax; 30 minutes following the end of the atezolizumab infusion) for each respective day.
- measure
- Maximum Observed Serum Concentration (Cmax) of Atezolizumab in the Global Population
- time Frame
- Post-dose Day 1 of Cycle 1 (cycle length = 21 days)
- description
- Atezolizumab pre-dose plasma concentration (Cmin) for each respective day.
- measure
- Minimum Observed Serum Concentration (Cmin) of Atezolizumab in the Global Population
- time Frame
- Predose on Day 1 of Cycles 1, 3, 4, 8, 16 and 24 (cycle length = 21 days)
- description
- Plasma concentration of carboplatin in the Global population.
- measure
- Plasma Concentration of Carboplatin in the Global Population
- time Frame
- Predose, before end of infusion, and after end of carboplatin infusion on Day 1 of Cycle 1 and Cycle 3 (cycle = 21 days)
- description
- Plasma concentration of etoposide in the Global Population.
- measure
- Plasma Concentration of Etoposide in the Global Population
- time Frame
- Predose, before end of infusion, 1 and 4 hours after end of carboplatin infusion on Day 1 of Cycle 1 and Cycle 3 (cycle = 21 days)
Full study description
- brief Summary
- This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study was designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC. Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin + etoposide or placebo + carboplatin + etoposide on 21-day cycles for four cycles in the induction phase followed by maintenance with atezolizumab or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.
Source references
- references
- citation
- Bernabe R, Liu SV, Sanchez-Gastaldo A, Alonso Garcia M. Long-Term Survival and Stable Disease in a Patient with Extensive-Stage Small-Cell Lung Cancer after Treatment with Carboplatin, Etoposide and Atezolizumab. Oncol Ther. 2024 Mar;12(1):175-182. doi: 10.1007/s40487-023-00257-0. Epub 2024 Jan 27.
- pmid
- 38280181
- type
- DERIVED
- citation
- Liu SV, Mok TSK, Nabet BY, Mansfield AS, De Boer R, Losonczy G, Sugawara S, Dziadziuszko R, Krzakowski M, Smolin A, Hochmair MJ, Garassino MC, Gay CM, Heymach JV, Byers LA, Lam S, Cardona A, Morris S, Adler L, Shames DS, Reck M. Clinical and molecular characterization of long-term survivors with extensive-stage small cell lung cancer treated with first-line atezolizumab plus carboplatin and etoposide. Lung Cancer. 2023 Dec;186:107418. doi: 10.1016/j.lungcan.2023.107418. Epub 2023 Oct 31.
- pmid
- 37931445
- type
- DERIVED
- citation
- Liu SV, Reck M, Mansfield AS, Mok T, Scherpereel A, Reinmuth N, Garassino MC, De Castro Carpeno J, Califano R, Nishio M, Orlandi F, Alatorre-Alexander J, Leal T, Cheng Y, Lee JS, Lam S, McCleland M, Deng Y, Phan S, Horn L. Updated Overall Survival and PD-L1 Subgroup Analysis of Patients With Extensive-Stage Small-Cell Lung Cancer Treated With Atezolizumab, Carboplatin, and Etoposide (IMpower133). J Clin Oncol. 2021 Feb 20;39(6):619-630. doi: 10.1200/JCO.20.01055. Epub 2021 Jan 13.
- pmid
- 33439693
- type
- DERIVED
- citation
- Mansfield AS, Kazarnowicz A, Karaseva N, Sanchez A, De Boer R, Andric Z, Reck M, Atagi S, Lee JS, Garassino M, Liu SV, Horn L, Wen X, Quach C, Yu W, Kabbinavar F, Lam S, Morris S, Califano R. Safety and patient-reported outcomes of atezolizumab, carboplatin, and etoposide in extensive-stage small-cell lung cancer (IMpower133): a randomized phase I/III trial. Ann Oncol. 2020 Feb;31(2):310-317. doi: 10.1016/j.annonc.2019.10.021. Epub 2019 Dec 9.
- pmid
- 31959349
- type
- DERIVED
- citation
- Nishio M, Sugawara S, Atagi S, Akamatsu H, Sakai H, Okamoto I, Takayama K, Hayashi H, Nakagawa Y, Kawakami T. Subgroup Analysis of Japanese Patients in a Phase III Study of Atezolizumab in Extensive-stage Small-cell Lung Cancer (IMpower133). Clin Lung Cancer. 2019 Nov;20(6):469-476.e1. doi: 10.1016/j.cllc.2019.07.005. Epub 2019 Jul 31.
- pmid
- 31466854
- type
- DERIVED
- citation
- Horn L, Mansfield AS, Szczesna A, Havel L, Krzakowski M, Hochmair MJ, Huemer F, Losonczy G, Johnson ML, Nishio M, Reck M, Mok T, Lam S, Shames DS, Liu J, Ding B, Lopez-Chavez A, Kabbinavar F, Lin W, Sandler A, Liu SV; IMpower133 Study Group. First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer. N Engl J Med. 2018 Dec 6;379(23):2220-2229. doi: 10.1056/NEJMoa1809064. Epub 2018 Sep 25.
- pmid
- 30280641
- type
- DERIVED
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-5492dd0c4143ef8070f1
- requested nct id
- NCT02763579
- primary nct id
- NCT02763579
- source kind
- fda_spl_label
- source record id
- 87c7ca7b-0b4e-456a-8338-80c9613edb36
- source file sha256
- 424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
- payload sha256
- b2f0bdbd4c7c17282ac8d7557fd7a4f0b9659896a4f3bd99ec42b398ae1d495d
- payload
- application numbers
- BLA761347
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-5492dd0c4143ef8070f1
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT02763579
- occurrences
- context exact
- orte studies). Small Cell Lung Cancer (SCLC) IMpower133 The efficacy of intravenous atezolizumab with carboplatin and etoposide was investigated in IMpower133 (NCT02763579), a randomized (1:1), multicenter, double-blind, placebo-controlled trial in 403 patients with ES-SCLC. IMpower133 enrolled patients with ES-SCLC who had recei
- end
- 31269
- exact text
- NCT02763579
- start
- 31258
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00500.json
- source file sha256
- 424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
- source json pointer
- /results/4/clinical_studies/0
- source kind
- fda_spl_label
- source record id
- 87c7ca7b-0b4e-456a-8338-80c9613edb36
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 7749bbeab1cb94c0f70463dfb63f7695d79c0493295eb253176c583eaf254925
- spl effective time
- 20260520
- spl set id
- a617b089-ce66-464b-987b-b45d029b4d6f
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-e50e72865737d0ac33db
- requested nct id
- NCT02763579
- primary nct id
- NCT02763579
- source kind
- fda_spl_label
- source record id
- 4b922b35-c401-4189-a8b2-9f9a820878db
- source file sha256
- bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
- payload sha256
- cef374abb41e5f47eefb868ce0298f9d3582aa6a88f4a8d45053d52a3cc03562
- payload
- application numbers
- BLA761034
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-e50e72865737d0ac33db
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT02763579
- occurrences
- context exact
- (95% CI: 0.55, 0.83). Figure 5 14.2 Small Cell Lung Cancer IMpower133 The efficacy of TECENTRIQ with carboplatin and etoposide was investigated in IMpower133 (NCT02763579), a randomized (1:1), multicenter, double-blind, placebo-controlled trial in 403 patients with ES-SCLC. IMpower133 enrolled patients with ES-SCLC who had recei
- end
- 26422
- exact text
- NCT02763579
- start
- 26411
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00300.json
- source file sha256
- bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
- source json pointer
- /results/10/clinical_studies/0
- source kind
- fda_spl_label
- source record id
- 4b922b35-c401-4189-a8b2-9f9a820878db
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 5de9b92c1a809fc68061204c0484085f3fd2df30cbe7a2aefcd7758b1dfb8fe0
- spl effective time
- 20260520
- spl set id
- 6fa682c9-a312-4932-9831-f286908660ee
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-f321df959d5be6f91205
- requested nct id
- NCT02763579
- primary nct id
- NCT02763579
- source kind
- nci_explicit_reference_or_link
- source record id
- Source null
- source file sha256
- def8807fa9dced3053a5e17815e0b3a72969a547af852b3a8a8c6960753960cd
- payload sha256
- 914d2637c4f41c228d92e5ba176216c45b4ad8130910633e3af65eb49fb8b31d
- payload
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-f321df959d5be6f91205
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT02763579
- occurrences
- context exact
- odulation and combination chemotherapy):</p> <div class="pdq-content-list"><ol id="_485450"><li><strong>Atezolizumab</strong>. <a href="/clinicaltrials/NCT02763579">IMpower133</a> (NCT02763579), a double-blind, placebo-controlled, randomized, phase III trial, compared four cycles of carboplatin and etoposide with either a
- end
- 121992
- exact text
- NCT02763579
- start
- 121981
- context exact
- motherapy):</p> <div class="pdq-content-list"><ol id="_485450"><li><strong>Atezolizumab</strong>. <a href="/clinicaltrials/NCT02763579">IMpower133</a> (NCT02763579), a double-blind, placebo-controlled, randomized, phase III trial, compared four cycles of carboplatin and etoposide with either atezolizumab (n = 201) or plac
- end
- 122021
- exact text
- NCT02763579
- start
- 122010
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/nci/raw/2cbbafe249fd41eec1.html
- source file sha256
- def8807fa9dced3053a5e17815e0b3a72969a547af852b3a8a8c6960753960cd
- source json pointer
- Source null
- source kind
- nci_explicit_reference_or_link
- source record id
- Source null
- source retrieved at
- 2026-09-09T23:21:59.810322+00:00
- source string basis
- UTF-8_text_with_universal_newline_translation
- source string sha256
- b376c91ad09eb8f2c14d2bbdf7eadfa5634343c1e1f1e7885a272dfdb4eb487c
- source title
- Small Cell Lung Cancer Treatment (PDQ®)–Health Professional Version
- source update dates
- context
- Updated: May 14, 2025
- datetime
- 2025-05-14T12:00:00Z
- display
- May 14, 2025
Preserved source evidence · Not medical advice