A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer (IMforte)

A Phase III, Randomized, Open-Label, Multicenter Study of Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab as Maintenance Therapy in Participants With Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following First-Line Induction Therapy With Carboplatin, Etoposide and Atezolizumab

Study GO43104 is a Phase III, randomized, open-label, multicenter study of lurbinectedin in combination with atezolizumab compared with atezolizumab alone administered as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) after first-line induction therapy with carboplatin, etoposide, and atezolizumab. The study consists of 2 phases: an induction phase and a maintenance phase. Participants need to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria after completion of 4 cycles of carboplatin, etoposide, and atezolizumab induction treatment in order to be considered for eligibility screening for the maintenance phase. Eligible participants will be randomized in a 1:1 ratio to receive either lurbinectedin plus atezolizumab or atezolizumab in the maintenance phase.

Study Overview

• Status: Active, not recruiting
• Conditions: Small-Cell Lung Cancer
• Intervention / Treatment: Drug: Atezolizumab; Drug: Lurbinectedin; Drug: Carboplatin; Drug: Etoposide

• Study Type: Interventional
• Enrollment (Actual): 660
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Anderlecht, Belgium, 1070
    • Institut Jules Bordet
  • Hasselt, Belgium, 3500
    • Jessa Zkh (Campus Virga Jesse)
  • Leuven, Belgium, 3000
    • UZ Leuven Gasthuisberg
  • Mechelen, Belgium, 2800
    • AZ St Maarten Campus Leopoldstr
  • Mont-godinne, Belgium, 5530
    • CHU UCL Mont-Godinne
  • Sint-Niklaas, Belgium, 9100
    • Vitaz
• Germany
  • Bad Berka, Germany, 99437
    • Zentralklinik Bad Berka GmbH
  • Berlin, Germany, 13125
    • Evang. Lungenklinik Berlin Klinik für Pneumologie
  • Berlin, Germany, 14165
    • Helios Klinikum Emil von Behring GmbH
  • Chemnitz, Germany, 09116
    • Klinikum Chemnitz gGmbH
  • Essen, Germany, 45136
    • KEM/Evang. Kliniken Essen Mitte gGmbH
  • Georgsmarienhütte, Germany, 49124
    • Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
  • Großhansdorf, Germany, 22927
    • LungenClinic Großhansdorf GmbH
  • Halle, Germany, 06120
    • Krankenhaus Martha-Maria Halle-Doelau gGmbH
  • Immenhausen, Germany, 34376
    • Fachklinik für Lungenerkrankungen
  • Lübeck, Germany, 23538
    • Universitätsklinikum Schleswig-Holstein
  • München-Gauting, Germany, 82131
    • Asklepios Klinik Gauting
• Greece
  • Athens, Greece, 115 27
    • Sotiria Thoracic Diseases Hospital of Athens
  • Athens, Greece, 11526
    • Errikos Dynan Hospital
  • Larissa, Greece, 411 10
    • University Hospital of Larissa
  • Thessaloniki, Greece, 570 01
    • Diavalkaniko Hospital
  • Thessaloniki, Greece, 546 45
    • Euromedical General Clinic of Thessaloniki
  • Thessaloniki, Greece, 55236
    • Ag. Loukas Hospital
• Hungary
  • Budapest, Hungary, 1121
    • Orszagos Koranyi Pulmonologiai Intezet
  • Pécs, Hungary, 7623
    • Pécsi Tudományegyetem
  • Szolnok, Hungary, 5000
    • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
  • Törökbálint, Hungary, 2045
    • Tudogyogyintezet Torokbalint
• Italy
  • Emilia-Romagna
    • Ravenna, Emilia-Romagna, Italy, 48121
      • AUSL della Romagna
  • Liguria
    • Genoa, Liguria, Italy, 16125
      • ASL 3 Genovese
  • Lombardy
    • Milan, Lombardy, Italy, 20162
      • Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
    • Milan, Lombardy, Italy, 20141
      • Irccs Istituto Europeo di Oncologia (IEO)
  • The Marches
    • Torrette Di Ancona, The Marches, Italy, 60126
      • Azienda Ospedaliero Universitaria Ospedali Riuniti
• Mexico
  • Morelia, Mexico, 58260
    • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
  • Mexico CITY (federal District)
    • Mexico City, Mexico CITY (federal District), Mexico, 03100
      • Health Pharma Professional Research
• Poland
  • Gda?sk, Poland, 80-214
    • Uniwersyteckie Centrum Kliniczne
  • Krakow, Poland, 31-202
    • Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II
  • Olsztyn, Poland, 10-357
    • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
  • Otwock, Poland, 05-400
    • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
  • Poznan, Poland, 60-569
    • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
  • Warsaw, Poland, 02-781
    • Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie
• South Korea
  • Cheongju-si, South Korea, 28644
    • Chungbuk National University Hospital
  • Daegu, South Korea, 702-210
    • Chilgok Kyungpook National University Medical Center
  • Gyeongsangnam-do, South Korea, 51353
    • Samsung Changwon Hospital
  • Gyeongsangnam-do, South Korea, 52727
    • Gyeongsang National University Hospital
  • Seongnam-si, South Korea, 13605
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Ulsan, South Korea, 44033
    • Ulsan University Hosiptal
• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08035
    • Vall d'Hebron Institute of Oncology (VHIO), Barcelona
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Málaga, Spain, 29010
    • Hospital Clinico Universitario Virgen de la Victoria
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • LA Coruna
    • A Coruña, LA Coruna, Spain, 15006
      • Complejo Hospitalario Universitario A Coruña (CHUAC)
• Taiwan
  • Kaohsiung City, Taiwan, 824
    • E-DA Hospital
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital
  • Tainan, Taiwan, 00704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06490
    • Ankara Bilkent City Hospital
  • Ankara, Turkey (Türkiye), 06520
    • Memorial Ankara Hastanesi
  • Ankara, Turkey (Türkiye), 06680
    • Liv Hospital Ankara
  • Ankara, Turkey (Türkiye), 06010
    • Gülhane E?itim Ve Ara?t?rma Hastanesi
  • Bursa, Turkey (Türkiye), 16059
    • Uludag Uni Hospital
  • Denizli, Turkey (Türkiye), 20070
    • Pamukkale University School Of Medicine
  • Diyarbakır, Turkey (Türkiye), 21280
    • Dicle University Faculty of Medicine
  • Edirne, Turkey (Türkiye), 22030
    • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
  • Istanbul, Turkey (Türkiye), 34300
    • Istanbul Uni Cerrahpasa Medical Faculty Hospital
  • Istanbul, Turkey (Türkiye), 34214
    • Ba?c?lar Medipol Mega Üniversite Hastanesi
  • Istanbul, Turkey (Türkiye), 34660
    • Ac?badem Altunizade Hastanesi
  • Izmir, Turkey (Türkiye), 35101
    • Izmir Medical Point Hospital
  • Kadiköy, Turkey (Türkiye), 34722
    • Goztepe Prof.Dr. Suleyman Yalcin City Hospital
  • Samsun, Turkey (Türkiye), 55200
    • Medikal Park Samsun
  • Selçuklu, Turkey (Türkiye), 42080
    • TC Necmettin Erbakan University Meram Medical Faculty Hospital
  • İzmit, Turkey (Türkiye), 31380
    • Kocaeli University Faculty of Medicine
• United Kingdom
  • Blackpool, United Kingdom, FY3 8NR
    • Blackpool Victoria Hospital
  • GB Manchester, United Kingdom, M20 4BX
    • Christie NHS Foundation Trust
  • Hull, United Kingdom, HU16 5JQ
    • Castle Hill Hospital
  • Leeds, United Kingdom, LS9 7TF
    • St James University Hospital
  • Leicester, United Kingdom, LE1 5WW
    • Leicester Royal Infirmary
  • London, United Kingdom, SE1 9RT
    • Guy's Hospital
• United States
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
  • Illinois
    • Peoria, Illinois, United States, 61615
      • Illinois Cancer Care
  • Maine
    • Scarborough, Maine, United States, 04074
      • New England Cancer Specialists
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Cancer & Hematology Centers of Western Michigan
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Mercy Research - St. Louis
  • New York
    • Westbury, New York, United States, 11590
      • Clinical Research Alliance
  • Ohio
    • Columbus, Ohio, United States, 43219
      • The Mark H. Zangmeister Ctr
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Hollings Cancer Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Greco-Hainesworth Centers for Research
    • Germantown, Tennessee, United States, 38138
      • West Clinic
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute / Tennessee Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria for the Induction Phase:

• ECOG PS of 0 or 1
• No prior systemic therapy for ES-SCLC
• 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
• Histologically or cytologically confirmed ES-SCLC
• Adequate hematologic and end-organ function to receive 4 cycles of induction treatment with carboplatin, etoposide and atezolizumab
• Measurable disease, as defined by RECIST v1.1
• Negative HIV test and no evidence of active Hepatitis B or Hepatitis C at screening

Exclusion Criteria for the Induction Phase:

• Presence or history of CNS metastases
• Active or history of autoimmune disease or deficiency
• History of malignancies other than SCLC within 5 years prior to enrollment
• Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, or lurbinectedin or trabectedin
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
• Treatment with investigational therapy within 28 days prior to enrollment

Inclusion Criteria for the Maintenance Phase:

• ECOG PS of 0 or 1
• Ongoing response or stable disease per RECIST 1.1 after 4 cycles of induction therapy
• Toxicities attributed to prior induction anti-cancer therapy or PCI resolved to Grade <=1
• Adequate hematologic and end-organ function

Exclusion Criteria for the Maintenance Phase:

• Presence or history of CNS metastases
• Receiving consolidative chest radiation
• Severe infection within 2 weeks prior to randomization into the maintenance
• Treatment with therapeutic oral or IV antibiotics at the time of randomization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Atezolizumab+Lurbinectedin; Induction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle in combination with lurbinectedin on Day 1 of each 21-day cycle.	Drug: Atezolizumab; Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle for 4 cycles in the induction phase. Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle in the maintenance phase.; Other Names: Tecentriq, RO5541267; Drug: Lurbinectedin; Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 of each 21-day cycle in the maintenance phase.; Other Names: PM01183/JZP712; Drug: Carboplatin; Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.; Drug: Etoposide; Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.
Active Comparator: Arm B: Atezolizumab; Induction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle.	Drug: Atezolizumab; Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle for 4 cycles in the induction phase. Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle in the maintenance phase.; Other Names: Tecentriq, RO5541267; Drug: Carboplatin; Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.; Drug: Etoposide; Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Randomized Phase: Independent Review Facility (IRF) - Assessed Progression Free Survival (PFS)	PFS was defined as the time from randomization to the date of first documented PD as determined by the IRF according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or death, whichever occurs first. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimetres (mm).	Up to 26 months
Randomized Phase: Overall Survival (OS)	OS was defined as the time from randomization to the date of death from any cause.	Up to 26 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Randomized Phase: Investigator-assessed PFS	PFS was defined as the time from randomization to the date of first documented PD as assessed by investigator according to RECIST v1.1 or death, whichever occurs first. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.	Up to 26 months
Randomized Phase: Confirmed Objective Response Rate (ORR) as Determined by the IRF	ORR was defined as the percentage of participants with an objective tumor response of complete response (CR) or partial response (PR) as determined by the IRF using RECIST v.1.1. CR was defined as the disappearance of all target and non-target lesions or any pathological lymph nodes (whether target or non-target) have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. Percentages have been rounded off.	Up to 26 months
Randomized Phase: Confirmed ORR as Determined by the Investigator	ORR was defined as the percentage of participants with an objective tumor response of CR or PR as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD.	Up to 26 months
Randomized Phase: Duration of Response (DOR) as Determined by the IRF	DOR was calculated for participants who had a best confirmed OR of CR/PR. DOR= time from first occurrence of a documented OR until the time of documented PD as determined by IRF assessment using RECIST v1.1 or death from any cause, whichever occurs first. CR=disappearance of all target and non-target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR= at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.	Up to 26 months
Randomized Phase: DOR as Determined by the Investigator	DOR was calculated for participants who had a best confirmed OR of CR/PR. DOR= time from first occurrence of a documented OR until the time of documented PD as determined by investigator using RECIST v1.1 or death from any cause, whichever occurs first. CR=disappearance of all target and non-target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR= at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.	Up to 26 months
Randomized Phase: Percentage of Participants With PFS as Determined by the IRF at 6 Months and 12 Months	PFS rate at 6 months and 12 months was defined as the percentage of participants who had not experienced PD as determined by the IRF according to RECIST v1.1 or death from any cause at 6 months and 12 months after randomization. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Percentages have been rounded off.	Months 6 and 12
Randomized Phase: Percentage of Participants With PFS Determined by Investigator at 6 Months and 12 Months	PFS rate at 6 months and 12 months was defined as the percentage of participants who had not experienced PD as determined by the investigator according to RECIST v1.1 or death from any cause at 6 months and 12 months after randomization. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Percentages have been rounded off.	Months 6 and 12
Randomized Phase: Percentage of Participants With OS at 12 Months and 24 Months	OS rate at 12 months and 24 months was defined as the percentage of participants who had not experienced death from any cause at 12 months and 24 months after randomization. Percentages have been rounded off.	Months 12 and 24
Randomized Phase: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)	An AE =any unfavorable & unintended sign (including abnormal laboratory values/abnormal clinical test results), symptoms/disease temporally associated with the use of a pharmaceutical product, whether considered related to the pharmaceutical product. SAE=any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above. AESI= drug induced liver injury, suspected transmission of infectious agent via study treatment, hepatitis, systemic lupus erythematosus, hypersensitivity, etc. AESIs may include events not specified in the protocol.	Up to 26 months
Randomized Phase: Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab	For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed at least one positive post-baseline ADA result during the randomized phase, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the baseline titer result.	Up to 26 months
Randomized Phase: Time to Confirmed Deterioration (TTCD) in Physical Functioning (PF) and Global Health Status (GHS) as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQC30)	EORTC QLQ-C30=30 questions assessing 5 aspects of participant functioning(physical,emotional,role,cognitive &social),3 symptom scales,GHS/QoL & 6 single items.PF scale=5 questions about participants PF & daily activities(strenuous activities,long walks,short walks,bed/chair rest & needing help with eating,dressing,washing themselves/using the toilet).PF scale scored on 4-point scale(1=Not at All-4=Very Much).GHS/QoL scored on 7-point scale(1=Very Poor- 7=Excellent).Scores were linearly transformed to a range of 0-100,higher scores=higher response level & better QoL.TTCD for PF & GHS/QoL=time from the date of randomization until first confirmed clinically meaningful deterioration,which is decrease from baseline in PF/GHS score that must be held for at least 2 consecutive assessments/initial decrease above baseline followed by death attributable to cancer progression within 6 weeks of the last deteriorated assessment.Score change≥10-point change in subscale score,considered meaningful.	Up to 26 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Jazz Pharmaceuticals
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

General Publications

• Paz-Ares L, Borghaei H, Liu SV, Peters S, Herbst RS, Stencel K, Majem M, Sendur MAN, Czyzewicz G, Caro RB, Lee KH, Johnson ML, Karadurmus N, Grohe C, Baka S, Csoszi T, Ahn JS, Califano R, Yang TY, Kemal Y, Ballinger M, Cuchelkar V, Graupner V, Lin YC, Chakrabarti D, Bhatt K, Cai G, Iannone R, Reck M; IMforte investigators. Efficacy and safety of first-line maintenance therapy with lurbinectedin plus atezolizumab in extensive-stage small-cell lung cancer (IMforte): a randomised, multicentre, open-label, phase 3 trial. Lancet. 2025 Jun 14;405(10495):2129-2143. doi: 10.1016/S0140-6736(25)01011-6. Epub 2025 Jun 2.

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2021
• Primary Completion (Actual): July 29, 2024
• Study Completion (Estimated): August 13, 2026

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Small Cell Lung Carcinoma; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glucosides; Glycosides; Coordination Complexes; Etoposide; Carboplatin; PM 01183; atezolizumab
• Other Study ID Numbers: GO43104; 2023-503868-16-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No