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SKYSCRAPER-02: A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04256421
Collaborator
(none)
490
Enrollment
124
Locations
2
Arms
49.5
Anticipated Duration (Months)
4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with chemotherapy-naive extensive-stage small cell lung cancer (ES-SCLC). Eligible participants will be stratified by Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), LDH (</= upper limit of normal [ULN] vs. > ULN), and presence or history of brain metastasis (yes vs. no) and randomly assigned in a 1:1 ratio to receive one of the following treatment regimens during induction phase:

  • Arm A: Tiragolumab plus atezolizumab plus CE

  • Arm B: Placebo plus atezolizumab plus CE

Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab plus placebo (Arm B).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
490 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab (Anti-Tigit Antibody) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
Actual Study Start Date :
Feb 4, 2020
Anticipated Primary Completion Date :
Sep 6, 2022
Anticipated Study Completion Date :
Mar 21, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tiragolumab + Atezolizumab + CE

Participants will receive atezolizumab on Day 1 of each 21-day cycle followed by tiragolumab on Day 1 of each 21-day cycle. Carboplatin will be administered followed by etoposide on Day 1 for 4 cycles. Participants will also receive etoposide on Days 2 and 3.

Drug: Tiragolumab
Tiragolumab 600 milligrams (mg) administered by IV infusion on Day 1 of each 21-day cycle.
Other Names:
  • MTIG7192A

    • Drug: Atezolizumab
    Atezolizumab 1200 mg administered by IV infusion on Day 1 of each 21-day cycle.
    Other Names:
  • Tecentriq

    • Drug: Carboplatin
    Carboplatin was administered by IV infusion on Day 1 of each 21-day cycle for 4 cycles.

    Drug: Etoposide
    Etoposide 100 mg/m^2 administered by IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles.
    Active Comparator: Placebo + Atezolizumab + CE

    Participants will receive atezolizumab on Day 1 of each 21-day cycle followed by placebo on Day 1 of each 21-day cycle. Carboplatin will be administered followed by etoposide on Day 1 for 4 cycles. Participants will also receive etoposide on Days 2 and 3.

    Drug: Atezolizumab
    Atezolizumab 1200 mg administered by IV infusion on Day 1 of each 21-day cycle.
    Other Names:
  • Tecentriq

    • Drug: Carboplatin
    Carboplatin was administered by IV infusion on Day 1 of each 21-day cycle for 4 cycles.

    Drug: Etoposide
    Etoposide 100 mg/m^2 administered by IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles.

    Drug: Placebo
    Placebo administered by IV infusion on Day 1 of each 21-day cycle.

    Outcome Measures

    Primary Outcome Measures

    1. Investigator-Assessed Progression Free Survival (PFS) in the Primary Analysis Set (PAS) [From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 50 months)]

    2. Overall Survival (OS) in the PAS [From randomization to death from any cause (up to 50 months)]

    Secondary Outcome Measures

    1. PFS in the Full Analysis Set (FAS) [From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 50 months)]

    2. OS in the FAS [From randomization to death from any cause (up to 50 months)]

    3. Investigator-Assessed Confirmed Objective Response Rate (ORR) in the PAS [From randomization up to 50 months]

    4. Investigator-Assessed Confirmed ORR in the FAS [From randomization up to 50 months]

    5. Investigator-Assessed Duration of Response (DOR) in the PAS [From the first occurrence of a documented confirmed objective response to disease progression or death from any cause, whichever occurs first ( up to 50 months)]

    6. Investigator-Assessed DOR in the FAS [From the first occurrence of a documented confirmed objective response to disease progression or death from any cause, whichever occurs first ( up to 50 months)]

    7. Investigator-Assessed PFS Rates at 6 Months and 12 Months in the PAS [6 months, 12 months]

    8. Investigator-Assessed PFS Rates at 6 Months and 12 Months in the FAS [6 months, 12 months]

    9. Overall Survival Rates at 12 Months and 24 Months in the PAS [12 months, 24 months]

    10. Overall Survival Rates at 12 Months and 24 Months in the FAS [12 months, 24 months]

    11. Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score in the PAS [From randomization until the first confirmed clinically meaningful deterioration up to 50 months]

      TTCD using EORTC QLQ-C30 is an initial 10-point decrease in global health status (GHS)/quality of life (QoL) and functioning from baseline that must be held for at least two consecutive assessments or an initial clinically meaningful decrease above baseline followed by death. EORTC QLQ-C30: a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting and pain), GHS and QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) with a recall period of the previous week. Functioning items are scored on a 4-point scale: 1=Not at all to 4=Very much, with higher score indicating worse outcome. Symptom items (GHS and QoL) are scored on a 7-point scale: 1=Very poor to 7=Excellent. Scores will be linearly transformed with a minimum score of 0 and maximum score of 100. Higher score indicates better outcome.

    12. TTCD Assessed Using EORTC QLQ-C30 Score in the FAS [From randomization until the first confirmed clinically meaningful deterioration up to 50 months]

      TTCD using EORTC QLQ-C30 is an initial 10-point decrease in global health status (GHS)/quality of life (QoL) and functioning from baseline that must be held for at least two consecutive assessments or an initial clinically meaningful decrease above baseline followed by death. EORTC QLQ-C30: a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting and pain), GHS and QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) with a recall period of the previous week. Functioning items are scored on a 4-point scale: 1=Not at all to 4=Very much, with higher score indicating worse outcome. Symptom items (GHS and QoL) are scored on a 7-point scale: 1=Very poor to 7=Excellent. Scores will be linearly transformed with a minimum score of 0 and maximum score of 100. Higher score indicates better outcome.

    13. Percentage of Participants With Adverse Events [Up to 50 months]

    14. Minimum Serum Concentration (Cmin) of Tiragolumab [Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at treatment discontinuation (TD) visit (up to 50 months).]

    15. Cmin of Atezolizumab [Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at TD visit (up to 50 months)]

    16. Maximum Serum Concentration (Cmax) of Tiragolumab [Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at TD visit (up to 50 months)]

    17. Cmax of Atezolizumab [Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at TD visit (up to 50 months)]

    18. Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab [Predose on Day 1 of Cycles 1 (each cycle is 21 days), 2, 3, 4, 8,12 and 16 and at TD visit (up to 50 months)]

    19. Percentage of Participants With ADAs to Atezolizumab [Predose on Day 1 of Cycles 1 (each cycle is 21 days), 2, 3, 4, 8,12 and 16 and at TD visit (up to 50 months)]

    20. Change from Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Index-based and Visual Analog Scale Scores [From baseline up to 50 months]

      The EQ-5D-5L is a validated self-report health status questionnaire that is used to calculate a health status utility score for use in health economic analyses. There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a visual analog scale (VAS) that measures health state. A single composite score is calculated based on the responses as an indicator of the participant's health status.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC)

    • No prior systemic treatment for ES-SCLC

    • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

    • Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (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:

    • Symptomatic or actively progressing central nervous system (CNS) metastases

    • Malignancies other than small cell lung cancer (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

    • Active or history of autoimmune disease or immune deficiency

    • 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

    • Positive test result for human immunodeficiency virus (HIV)

    • Active hepatitis B or hepatitis C

    • Severe infection at the time of randomization

    • Treatment with any other investigational agent within 28 days prior to initiation of study treatment

    • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-cytotoxic T lymphocyte-associated protein 4 (anti-CTLA-4), anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies

    • Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug elimination half-lives prior to randomization

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rocky Mountain Cancer Centers - Lone Tree Lone Tree Colorado United States 80124
    2 MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center) Washington District of Columbia United States 20007
    3 Florida Cancer Specialists; SCRI; Florida Cancer Specialists - Sarasota (Golf St) Fort Myers Florida United States 33901
    4 SCRI Florida Cancer Specialists North; Research Office North Region. Saint Petersburg Florida United States 33705
    5 Northwest Georgia Oncology Centers PC - Marietta Marietta Georgia United States 30060
    6 Illinois Cancer Care Peoria Illinois United States 61615
    7 New England Cancer Specialists Scarborough Maine United States 04074
    8 Weinberg Cancer Institution at Franklin Square Baltimore Maryland United States 21237
    9 Minnesota Oncology Hematology Saint Paul Minnesota United States 55102
    10 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89128
    11 Broome Oncology - Binghamton Binghamton New York United States 13905
    12 Mount Sinai - PRIME; Icahn School of Medicine at Mount Sinai New York New York United States 10029
    13 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    14 SCRI Tennessee Oncology Chattanooga Chattanooga Tennessee United States 37404
    15 SARAH CANNON RESEARCH INST.; Tennessee Oncology, PLLC Nashville Tennessee United States 37203
    16 Texas Oncology Cancer Center Austin Texas United States 78731
    17 Virginia Cancer Specialists Fairfax Virginia United States 22031
    18 Blue Ridge Cancer Care Roanoke Virginia United States 24014
    19 University of Wisconsin School of Medicine and Public Health Madison Wisconsin United States 53792
    20 Chris O'Brien Lifehouse Camperdown New South Wales Australia 2050
    21 Nepean Hospital; Nepean Cancer Care Centre Kingswood New South Wales Australia 2747
    22 Sunshine Coast University Hospital; The Adem Crosby Centre Birtinya Queensland Australia 4575
    23 Lyell McEwin Hospital; Oncology Clinical Trials, Chemotherapy Day Unit Elizabeth Vale South Australia Australia 5112
    24 Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie Innsbruck Austria 6020
    25 SMZ - Baumgartner Hohe, Otto-Wagner-Spital; 2.Interne Lungenabteilung Wien Austria 1140
    26 Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie Wien Austria 1210
    27 AZ St Maarten Campus Leopoldstr Mechelen Belgium 2800
    28 Clinique Ste-Elisabeth Namur Belgium 5000
    29 AZ Delta (Campus Rumbeke) Roeselare Belgium 8800
    30 Vitaz Sint Niklaas Belgium 9100
    31 Hospital Sao Rafael - HSR Salvador BA Brazil 41253-190
    32 Oncocentro Serviços Médicos e Hospitalares Ltda Fortaleza CE Brazil 60130-241
    33 Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia Passo Fundo RS Brazil 99010-260
    34 Hospital Nossa Senhora da Conceicao Porto Alegre RS Brazil 91350-200
    35 Clínica de Oncologia Reichow Blumenau SC Brazil 89010-340
    36 Instituto do Cancer do Estado de Sao Paulo - ICESP Sao Paulo SP Brazil 01246-000
    37 Fakultni nemocnice Olomouc; Pneumologicka klinika Olomouc Czechia 775 20
    38 Vitkovicka Nemocnice Bma, A.S.; Plicni Oddeleni Ostrava Czechia 703 84
    39 Thomayerova nemocnice; Pneumologicka klinika 1.LF UK TN Praha 4 - Krc Czechia 140 59
    40 Helios Klinikum Emil von Behring GmbH Berlin Germany 14165
    41 LungenClinic Großhansdorf GmbH Großhansdorf Germany 22927
    42 Asklepios Klinik Harburg Hamburg Germany 21075
    43 Fachklinik für Lungenerkrankungen Immenhausen Germany 34376
    44 Universitätsklinikum Schleswig-Holstein; Campus Lübeck Lübeck Germany 23538
    45 Asklepios Klinik München-Gauting München-Gauting Germany 82131
    46 General Hospital "G.Papanikolaou"; Pulmonogy Clinic Asvestochori Greece 570 10
    47 Uoa Sotiria Hospital; Oncology Athens Greece 115 27
    48 Metropolitan General Hospital Cholargos Greece 155 62
    49 Univ General Hosp Heraklion; Medical Oncology Heraklion Greece 711 10
    50 Orszagos Koranyi TBC es Pulmonologiai Intezet Budapest Hungary 1121
    51 Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int. Szolnok Hungary 5000
    52 Tudogyogyintezet Torokbalint Torokbalint Hungary 2045
    53 AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico Napoli Campania Italy 80131
    54 AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia Ravenna Emilia-Romagna Italy 48121
    55 IRCCS Istituto Clinico Humanitas; Oncologia Rozzano Lombardia Italy 20089
    56 Azienda Sanitaria Ospedaliera S Luigi Gonzaga Orbassano Piemonte Italy 10043
    57 Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica Bari Puglia Italy 70124
    58 Azienda Ospedaliero-Universitaria "PoliclinicoVittorio Emanuele"- P.O. G. Rodolico; Oncologia Medica Catania Sicilia Italy 95123
    59 Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica Siena Toscana Italy 53100
    60 IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda Padova Veneto Italy 35128
    61 National Cancer Center Hospital East Chiba Japan 277-8577
    62 Kyushu University Hospital Fukuoka Japan 812-8582
    63 Niigata Cancer Center Hospital Niigata Japan 951-8566
    64 Osaka International Cancer Institute Osaka Japan 541-8567
    65 Kindai University Hospital Osaka Japan 589-8511
    66 Saitama Cancer Center Saitama Japan 362-0806
    67 National Hospital Organization Kinki-Chuo Chest Medical Center Sakai-shi Japan 591-8555
    68 Shizuoka Cancer Center Shizuoka Japan 411-8777
    69 National Cancer Center Hospital Tokyo Japan 104-0045
    70 The Cancer Institute Hospital of JFCR Tokyo Japan 135-8550
    71 Wakayama Medical University Hospital Wakayama Japan 641-8510
    72 Chungbuk National University Hospital Cheongju-si Korea, Republic of 28644
    73 National Cancer Center Goyang-si Korea, Republic of 10408
    74 Samsung Changwon Hospital Gyeongsangnam-do Korea, Republic of 51353
    75 Seoul National University Bundang Hospital Seongnam-si Korea, Republic of 13605
    76 Seoul National University Hospital Seoul Korea, Republic of 03080
    77 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722
    78 Asan Medical Center Seoul Korea, Republic of 05505
    79 Samsung Medical Center Seoul Korea, Republic of 06351
    80 Seoul St Mary's Hospital Seoul Korea, Republic of 06591
    81 Ulsan University Hosiptal Ulsan Korea, Republic of 44033
    82 Maastricht University Medical Center Maastricht Netherlands 6229 HX
    83 Erasmus MC Rotterdam Netherlands 3015 GD
    84 Auckland City Hospital; Clinical Oncology Auckland New Zealand 1023
    85 Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny Brzozów Poland 36-200
    86 Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii Gdansk Poland 80-214
    87 Krakowski Szpital Specjalistyczny im.Jana Pawla II Krakow Poland 31-202
    88 Warminsko-Mazurskie Centrum Chorób Płuc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii Olsztyn Poland 10-357
    89 Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii Otwock Poland 05-400
    90 Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu Poznan Poland 60-569
    91 Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers Warszawa Poland 02-781
    92 Principal Military Clinical Hospital n.a. N.N. Burdenko Moscow Moskovskaja Oblast Russian Federation 105229
    93 BLOKHIN CANCER RESEARCH CENTER; CLINICAL ONCOLOGY; Clinical pharmacology and chemotheraphy Moscow Russian Federation
    94 Scientific Research Institute n.a. N.N. Petrov Saint Petersburg Russian Federation 197758
    95 Clinical Center of Serbia; Clinic for Pulmonary Diseases Belgrade Serbia 11000
    96 Clinical Hospital Center ''Bezanijska Kosa''; Department of Pulmology Belgrade Serbia 11080
    97 Institute for Pulmonary Diseases of Vojvodina Sremska Kamenica Serbia 21204
    98 National University Hospital; National University Cancer Institute, Singapore (NCIS) Singapore Singapore 119228
    99 National Cancer Centre; Medical Oncology Singapore Singapore 169610
    100 Vall d´Hebron Institute of Oncology (VHIO), Barcelona Barcelona Spain 08035
    101 Hospital Clinic Barcelona; Servicio de oncologia Barcelona Spain 08036
    102 Fundacion Jimenez Diaz; Servicio de Oncologia Madrid Spain 28040
    103 Hospital Universitario La Paz; Servicio de Oncologia Madrid Spain 28046
    104 Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia Malaga Spain 29010
    105 Hospital Universitario Virgen del Rocio; Servicio de Oncologia Sevilla Spain 41013
    106 Hospital Clínico Universitario de Valencia; Servicio de Oncología Valencia Spain 46010
    107 Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia Zaragoza Spain 50009
    108 CHUV; Departement d'Oncologie Lausanne Switzerland 1011
    109 UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie Zürich Switzerland 8091
    110 National Cheng-Kung University Hospital Tainan Taiwan
    111 Taipei Veterans General Hospital Taipei City Taiwan 11217
    112 Chang-Gung Medical Foundation, Linkou Branch Taoyuan Taiwan 333
    113 National Taiwan University Hospital; Oncology Zhongzheng Dist. Taiwan 10048
    114 Adana Baskent University Hospital; Medical Oncology Adana Turkey 01120
    115 Ankara University Medical Faculty; Medikal Onkoloji Ankara Turkey 06100
    116 Gazi University Medical Faculty Ankara Turkey 06500
    117 Istanbul University Cerrahpaşa-Cerrahpaşa Medical Faculty; Medikal Onkoloji Departmani Istanbul Turkey 34098
    118 Medipol University MF; Oncology Department Istanbul Turkey 34214
    119 İzmir Medical Park; Onkoloji Izmır Turkey 35575
    120 NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital Edinburgh United Kingdom EH4 2XU
    121 Guys and St Thomas Hospital London United Kingdom SE1 9RT
    122 Christie Foundation Trust Manchester United Kingdom M20 4BX
    123 Royal Marsden Hospital (Sutton) Sutton United Kingdom SM2 5PT
    124 Royal Cornwall Hospital Truro United Kingdom TR1 3LQ

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT04256421
    Other Study ID Numbers:
    • GO41767
    • 2019-003301-97
    First Posted:
    Feb 5, 2020
    Last Update Posted:
    Jul 29, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Small Cell Lung Carcinoma
    Carboplatin
    Etoposide
    Atezolizumab

    Study Results

    No Results Posted as of Jul 29, 2022