A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer) (Morpheus Lung)

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Non-Small Cell Lung Cancer (Morpheus-Lung)

This study will evaluate the efficacy, safety, and pharmacokinetics of immunotherapy-based treatment combinations in participants with metastatic non-small cell lung cancer (NSCLC).

Two cohorts will be enrolled in parallel in this study: Cohort 1 will consist of participants with tumor PD-L1 expression who have received no prior systemic therapy for metastatic NSCLC, and Cohort 2 will consist of participants who experienced disease progression during or following treatment with a platinum-containing regimen and a PD-L1/PD-1 checkpoint inhibitor, given in combination as one line of therapy or as two separate lines of therapy, regardless of PD-L1 expression. In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). Participants who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment regimen (Stage 2).

Study Overview

• Status: Recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: Atezolizumab; Drug: Cobimetinib; Drug: RO6958688; Drug: Tocilizumab; Drug: Docetaxel; Drug: CPI-444; Drug: Ipatasertib; Drug: Bevacizumab; Drug: Pemetrexed; Drug: Carboplatin; Drug: Gemcitabine; Drug: Linagliptin; Drug: Sacituzumab Govitecan; Other: Radiation; Drug: Evolocumab; Drug: Tiragolumab; Drug: XL092; Drug: Camonsertib

• Study Type: Interventional
• Enrollment (Estimated): 675
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: BO39610 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S. and Canada); Email: global-roche-genentech-trials@gene.com

Study Locations

• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Recruiting
      • Blacktown Hospital
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Completed
      • Peter Mac Callum Cancer Center
• France
  • Bordeaux, France, 33075
    • Recruiting
    • CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre
  • Dijon, France, 21000
    • Recruiting
    • Centre Georges Francois Leclerc
  • Lyon, France, 69008
    • Completed
    • Centre Léon Bérard
  • Marseille, France, 13005
    • Recruiting
    • Hôpital de la Timone
  • Montpellier, France, 34298
    • Recruiting
    • Institut Régional Du Cancer de Montpellier
  • Saint Herblain, France, 44115
    • Recruiting
    • Institut De Cancerologie De L'Ouest; Medical Oncology
  • Toulouse, France, 31100
    • Recruiting
    • Institut Universitaire du Cancer de Toulouse-Oncopole; PHARMACIE
• Israel
  • Haifa, Israel, 3109601
    • Recruiting
    • Rambam Medical Center; Oncology
  • Petach Tikva, Israel, 4922297
    • Recruiting
    • Rabin Medical Center
  • Ramat Gan, Israel, 5262100
    • Recruiting
    • Chaim Sheba Medical Center; Oncology Dept
• Korea, Republic of
  • Jeollanam-do, Korea, Republic of, 58128
    • Completed
    • Chonnam National University Hwasun Hospital
  • Seoul, Korea, Republic of, 08308
    • Recruiting
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 03080
    • Completed
    • Seoul National University Hospital
  • Songpa-gu, Korea, Republic of, 05505
    • Completed
    • University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC)
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari Vall d'Hebron
  • Madrid, Spain, 28040
    • Recruiting
    • Fundacion Jimenez Diaz
  • Madrid, Spain, 280146
    • Recruiting
    • Hospital Universitario La Paz
  • Madrid, Spain, 28050
    • Recruiting
    • Hospital Universitario HM Sanchinarro-CIOCC
  • Malaga, Spain, 29010
    • Recruiting
    • Hospital Regional Universitario de Málaga
  • Valencia, Spain, 46010
    • Recruiting
    • Hospital Clinico Universitario de Valencia
  • Navarra
    • Pamplona, Navarra, Spain, 31620
      • Recruiting
      • Clinica Universidad de Navarra
• Taiwan
  • Tainan City, Taiwan, 704
    • Completed
    • National Cheng Kung University Hospital; Gasterointestinal
  • Taipei City, Taiwan, 11217
    • Recruiting
    • Taipei Veterans General Hospital
• United Kingdom
  • London, United Kingdom, E1 2AT
    • Recruiting
    • Barts Cancer Institute
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Recruiting
    • The Newcastle Upon Tyne Hospitals NHS Foundation Trust
  • Sutton, United Kingdom, SM2 5PT
    • Recruiting
    • Royal Marsden Hospital; Institute of Cancer Research
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Completed
      • Smilow Cancer Hospital at Yale New Haven
  • Delaware
    • Newark, Delaware, United States, 19713
      • Recruiting
      • Christiana Care Health Services
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Withdrawn
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02215
      • Completed
      • Dana-Farber Cancer Institute
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Completed
      • Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
  • New York
    • New York, New York, United States, 10032
      • Completed
      • Columbia University Medical Center; Research Pharmacy, Irving Pavillion, Ip 7-749
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Withdrawn
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Case Medical Center; Seidman Cancer Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Completed
      • SCRI Oncology Partners

Participation Criteria

Eligibility Criteria

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

Description

General Inclusion Criteria

• Eastern Cooperative Oncology Group (ECOG) performance Status of 0 or 1
• Life expectancy greater than or equal to 3 months
• Histologically or cytologically confirmed metastatic, non-squamous or squamous Non-Small Cell Lung Cancer (NSCLC)
• Measurable disease (at least one target lesion)
• Adequate hematologic and end-organ function
• Tumor accessible for biopsy
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating eggs as outlined for each specific treatment arm
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm

Inclusion Criteria for Cohort 1

• No prior systemic therapy for metastatic NSCLC
• High tumor PD-L1 expression, defined as Tumor Proportion Score (TPS) or TCs >= 50% or TC3

Inclusion Criteria for Cohort 2

- Disease progression during or following treatment for metastatic or locally advanced, inoperable NSCLC

Exclusion Criteria

• Prior allogeneic stem cell or solid organ transplantation
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
• Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
• History of leptomeningeal disease
• Active or history of autoimmune disease or immune deficiency
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
• History of malignancy other than NSCLC within 2 years prior to screening
• Active tuberculosis
• Severe infection within 4 weeks prior to initiation of study treatment

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

23

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stage 1: Cohort 1: Atezolizumab; Participants in the Atezolizumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Participants who progressed on treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin or Atezolizumab + Gemcitabine + Carboplatin treatment, provided they meet the eligibility criteria.	Drug: Atezolizumab; Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.
Experimental: Stage 1: Cohort 1: Atezolizumab + Cobimetinib; Participants in the Atezolizumab + Cobimetinib arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit. Participants who progressed on 1L treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin or Atezolizumab + Gemcitabine + Carboplatin treatment, provided they meet the eligibility criteria. Participants who progressed on 2L/3L treatment, may have the option of receiving Atezolizumab + RO6958688, Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.	Drug: Atezolizumab; Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.; Drug: Cobimetinib; Cobimetinib is administered orally on Days 1-21 of a 28 day cycle.
Experimental: Stage 1: Cohort 1: Atezolizumab + RO6958688; Participants in the Atezolizumab + RO6958688 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Participants who progressed on 1L treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin or Atezolizumab + Gemcitabine + Carboplatin treatment, provided they meet the eligibility criteria. Participants who progressed on 2L/3L treatment, may have the option of receiving Atezolizumab + Docetaxel treatment or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.	Drug: Atezolizumab; Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.; Drug: RO6958688; Cycle 1: RO6958688 is administered by IV infusion on Days 1, 8, and 15 of a 21 day cycle at increasing dosage. Subsequent cycles: RO6958688 is administered by IV infusion on Days 1, 8, and 15 of a 21 day cycle.; Drug: Tocilizumab; Tocilizumab is administered for the management of cytokine-release syndrome in the RO6958688-containing arms.
Active Comparator: Stage 1: Cohort 2: Docetaxel; Participants in the Docetaxel arm will receive treatment (cycle length 21 days) until unacceptable toxicity or disease progression. Participants who progressed on treatment may have the option of receiving Atezolizumab + RO6958688 or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.	Drug: Docetaxel; Docetaxel is administered by IV on Day 1 of each 21 day cycle.
Experimental: Stage 1: Cohort 2: Atezolizumab + Cobimetinib; Participants in the Atezolizumab + Cobimetinib arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit. Participants who progressed on treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin, Atezolizumab + Gemcitabine + Carboplatin, Atezolizumab + RO6958688, Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.	Drug: Atezolizumab; Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.; Drug: Cobimetinib; Cobimetinib is administered orally on Days 1-21 of a 28 day cycle.
Experimental: Stage 1: Cohort 2: Atezolizumab + CPI-444; Participants in the Atezolizumab + CPI-444 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Participants who progressed on treatment, may have the option of receiving Atezolizumab + RO6958688, Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.	Drug: Atezolizumab; Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.; Drug: CPI-444; CPI-444 is administered orally twice daily on Days 1- 21, of a 21 day cycle.
Experimental: Stage 1: Cohort 2: Atezolizumab + RO6958688; Participants in the Atezolizumab + RO6958688 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Participants who progressed on treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin, Atezolizumab + Gemcitabine + Carboplatin, Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.	Drug: Atezolizumab; Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.; Drug: RO6958688; Cycle 1: RO6958688 is administered by IV infusion on Days 1, 8, and 15 of a 21 day cycle at increasing dosage. Subsequent cycles: RO6958688 is administered by IV infusion on Days 1, 8, and 15 of a 21 day cycle.; Drug: Tocilizumab; Tocilizumab is administered for the management of cytokine-release syndrome in the RO6958688-containing arms.
Experimental: Stage 1: Cohort 2: Atezolizumab + Ipatasertib; Participants in the Atezolizumab + Ipatasertib arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit. Participants who progressed on treatment, may have the option of receiving Atezolizumab + Docetaxel treatment or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.	Drug: Atezolizumab; Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.; Drug: Ipatasertib; Ipatasertib will be administered orally once a day on Days 1-21 of each 28-day cycle.
Experimental: Stage 1: Cohort 2: Atezolizumab + Docetaxel; Participants in Atezolizumab + Docetaxel arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Participants who progressed on treatment, may have the option of receiving Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.	Drug: Atezolizumab; Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.; Drug: Docetaxel; Docetaxel is administered by IV on Day 1 of each 21 day cycle.
Experimental: Stage 1: Cohort 2: Atezolizumab + Bevacizumab; Participants in Atezolizumab + Bevacizumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Participants who progressed on treatment, may have the option of receiving Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.	Drug: Atezolizumab; Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.; Drug: Bevacizumab; Bevacizumab is administered by IV on Day 1 of each 21-day cycle.
Experimental: Stage 2: Cohort 1: Atezolizumab + Pemetrexed + Carboplatin; Participants in the Atezolizumab + Pemetrexed + Carboplatin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.	Drug: Atezolizumab; Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.; Drug: Pemetrexed; Pemetrexed is administered by IV on Day 1 of a 21 day cycle.; Drug: Carboplatin; Carboplatin is administered by IV on day 1 of the first 4 or 6 cycles out of a 21 day cycle.
Experimental: Stage 2: Cohort 1: Atezolizumab + Gemcitabine + Carboplatin; Participants in the Atezolizumab + Gemcitabine + Carboplatin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.	Drug: Atezolizumab; Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.; Drug: Carboplatin; Carboplatin is administered by IV on day 1 of the first 4 or 6 cycles out of a 21 day cycle.; Drug: Gemcitabine; Gemcitabine is administered by IV on Days 1 and 8 of the first 4 or 6 cycles out of a 21 day cycle.
Experimental: Stage 2: Cohort 2: Atezolizumab + RO6958688; Participants in the Atezolizumab + RO6958688 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.	Drug: Atezolizumab; Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.; Drug: RO6958688; Cycle 1: RO6958688 is administered by IV infusion on Days 1, 8, and 15 of a 21 day cycle at increasing dosage. Subsequent cycles: RO6958688 is administered by IV infusion on Days 1, 8, and 15 of a 21 day cycle.; Drug: Tocilizumab; Tocilizumab is administered for the management of cytokine-release syndrome in the RO6958688-containing arms.
Experimental: Stage 2: Cohort 2: Atezolizumab + Docetaxel; Participants in the Atezolizumab + Docetaxel arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Participants who have received treatment with Atezolizumab + Docetaxel in Stage 1 will not receive this treatment in Stage 2.	Drug: Atezolizumab; Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.; Drug: Docetaxel; Docetaxel is administered by IV on Day 1 of each 21 day cycle.
Experimental: Stage 2: Cohort 2: Atezolizumab + Linagliptin; Participants in the Atezolizumab + Linagliptin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.	Drug: Atezolizumab; Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.; Drug: Linagliptin; Linagliptin is administered orally once daily on Days 1 to 21 out of a 21 day cycle.
Experimental: Stage 1: Cohort 2: Atezolizumab + Sacituzumab Govitecan; Participants in the Atezolizumab + Sacituzumab Govitecan arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.	Drug: Atezolizumab; Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.; Drug: Sacituzumab Govitecan; Sacituzumab Govitecan is administered by IV on Day 1 and 8 of each 21-day cycle.
Experimental: Stage 1: Cohort 2: Atezolizumab + Evolocumab; Participants in the Atezolizumab + Evolocumab arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit.	Drug: Atezolizumab; Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.; Drug: Evolocumab; Evolocumab is administered subcutaneously at a dose of 140 mg on Days 1 and 15 of each 28-day cycle.
Experimental: Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy; Participants in the Atezolizumab + Bevacizumab + Radioatherapy arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.	Drug: Atezolizumab; Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.; Drug: Bevacizumab; Bevacizumab is administered by IV on Day 1 of each 21-day cycle.; Other: Radiation; Radiotherapy up to 21 days
Active Comparator: Stage 1: Cohort 1: Atezolizumab + Tiragolumab; Participants in the Atezolizumab + Tiragolumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.	Drug: Atezolizumab; Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.; Drug: Tiragolumab; Tiragolumab is administered on Day 1 of each 21 day cycle.
Experimental: Stage 1: Cohort 1: Atezolizumab + Tiragolumab + XL092 (Zanzalintinib); Participants in the Atezolizumab + Tiragolumab + XL092 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.	Drug: Atezolizumab; Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.; Drug: Tiragolumab; Tiragolumab is administered on Day 1 of each 21 day cycle.; Drug: XL092; XL092 is administered orally once a day on Day 1 to Day 21 of a 21 day cycle.; Other Names: Zanzalintinib
Experimental: Stage 1: Cohort 2: Atezolizumab + Camonsertib; Participants in the Atezolizumab + Camonsertib arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.	Drug: Atezolizumab; Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.; Drug: Camonsertib; Camonsertib is administered orally on Days 1-3, Days 8-10 of a 21 day cycle.
Experimental: Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Camonsertib; Participants in the Atezolizumab + Bevacizumab + Comonsertib arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.	Drug: Atezolizumab; Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.; Drug: Bevacizumab; Bevacizumab is administered by IV on Day 1 of each 21-day cycle.; Drug: Camonsertib; Camonsertib is administered orally on Days 1-3, Days 8-10 of a 21 day cycle.
Experimental: Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Tiragolumab; Participants in the Atezolizumab + Bevacizumab + Tiragolumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.	Drug: Atezolizumab; Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.; Drug: Bevacizumab; Bevacizumab is administered by IV on Day 1 of each 21-day cycle.; Drug: Tiragolumab; Tiragolumab is administered on Day 1 of each 21 day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants with Objective Response	Every 6 weeks (starting on Day 1, Cycle 1) for the first 48 weeks and then every 6 or 12 weeks thereafter

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Who Are Alive at Month 6 and at Month 12	Month 6, Month 12
Progression Free Survival (PFS)	Randomization to the first occurrence of disease progression or death from any cause (up to approximately 8 years)
Overall Survival After Randomization	Randomization to death from any cause (up to approximately 8 years)
Duration of Response	First occurrence of a documented objective response to disease progression or death (up to approximately 8 years)
Disease Control	Randomization to the first occurrence of disease progression or death from any cause (up to approximately 8 years)
Percentage of Participants with Adverse Events	Baseline through the end of the study (approximately 8 years)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: November 7, 2017
• First Submitted That Met QC Criteria: November 7, 2017
• First Posted (Actual): November 9, 2017

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Protein Kinase Inhibitors; Immune Checkpoint Inhibitors; Serine Proteinase Inhibitors; Incretins; Folic Acid Antagonists; Dipeptidyl-Peptidase IV Inhibitors; Immunoconjugates; PCSK9 Inhibitors; Docetaxel; Carboplatin; Bevacizumab; Linagliptin; Pemetrexed; Atezolizumab; Evolocumab; Gemcitabine; Ipatasertib; Sacituzumab govitecan
• Other Study ID Numbers: BO39610; 2017-001267-21 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here ( https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

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