A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)
NCT ID: NCT03337698
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
314 participants
INTERVENTIONAL
2017-12-27
2025-11-25
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Cobimetinib
Cobimetinib is administered orally on Days 1-21 of a 28 day cycle.
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.
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.
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.
Tocilizumab
Tocilizumab is administered for the management of cytokine-release syndrome in the RO6958688-containing arms.
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.
Docetaxel
Docetaxel is administered by IV on Day 1 of each 21 day cycle.
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.
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.
Cobimetinib
Cobimetinib is administered orally on Days 1-21 of a 28 day cycle.
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.
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.
CPI-444
CPI-444 is administered orally twice daily on Days 1- 21, of a 21 day cycle.
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.
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.
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.
Tocilizumab
Tocilizumab is administered for the management of cytokine-release syndrome in the RO6958688-containing arms.
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.
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.
Ipatasertib
Ipatasertib will be administered orally once a day on Days 1-21 of each 28-day cycle.
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.
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.
Docetaxel
Docetaxel is administered by IV on Day 1 of each 21 day cycle.
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.
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.
Bevacizumab
Bevacizumab is administered by IV on Day 1 of each 21-day cycle.
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.
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.
Pemetrexed
Pemetrexed is administered by IV on Day 1 of a 21 day cycle.
Carboplatin
Carboplatin is administered by IV on day 1 of the first 4 or 6 cycles out of a 21 day cycle.
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.
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.
Carboplatin
Carboplatin is administered by IV on day 1 of the first 4 or 6 cycles out of a 21 day cycle.
Gemcitabine
Gemcitabine is administered by IV on Days 1 and 8 of the first 4 or 6 cycles out of a 21 day cycle.
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.
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.
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.
Tocilizumab
Tocilizumab is administered for the management of cytokine-release syndrome in the RO6958688-containing arms.
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.
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.
Docetaxel
Docetaxel is administered by IV on Day 1 of each 21 day cycle.
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.
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.
Linagliptin
Linagliptin is administered orally once daily on Days 1 to 21 out of a 21 day cycle.
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.
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.
Sacituzumab Govitecan
Sacituzumab Govitecan is administered by IV on Day 1 and 8 of each 21-day cycle.
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.
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.
Bevacizumab
Bevacizumab is administered by IV on Day 1 of each 21-day cycle.
Radiation
Radiotherapy up to 21 days
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.
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.
Evolocumab
Evolocumab is administered subcutaneously at a dose of 140 mg on Days 1 and 15 of each 28-day cycle.
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.
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.
Tiragolumab
Tiragolumab is administered on Day 1 of each 21 day cycle.
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.
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.
Tiragolumab
Tiragolumab is administered on Day 1 of each 21 day cycle.
XL092
XL092 is administered orally once a day on Day 1 to Day 21 of a 21 day cycle.
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.
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.
Camonsertib
Camonsertib is administered orally on Days 1-3, Days 8-10 of a 21 day cycle.
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.
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.
Bevacizumab
Bevacizumab is administered by IV on Day 1 of each 21-day cycle.
Camonsertib
Camonsertib is administered orally on Days 1-3, Days 8-10 of a 21 day cycle.
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.
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.
Bevacizumab
Bevacizumab is administered by IV on Day 1 of each 21-day cycle.
Tiragolumab
Tiragolumab is administered on Day 1 of each 21 day cycle.
Interventions
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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.
Cobimetinib
Cobimetinib is administered orally on Days 1-21 of a 28 day cycle.
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.
Docetaxel
Docetaxel is administered by IV on Day 1 of each 21 day cycle.
CPI-444
CPI-444 is administered orally twice daily on Days 1- 21, of a 21 day cycle.
Pemetrexed
Pemetrexed is administered by IV on Day 1 of a 21 day cycle.
Carboplatin
Carboplatin is administered by IV on day 1 of the first 4 or 6 cycles out of a 21 day cycle.
Gemcitabine
Gemcitabine is administered by IV on Days 1 and 8 of the first 4 or 6 cycles out of a 21 day cycle.
Linagliptin
Linagliptin is administered orally once daily on Days 1 to 21 out of a 21 day cycle.
Tocilizumab
Tocilizumab is administered for the management of cytokine-release syndrome in the RO6958688-containing arms.
Ipatasertib
Ipatasertib will be administered orally once a day on Days 1-21 of each 28-day cycle.
Bevacizumab
Bevacizumab is administered by IV on Day 1 of each 21-day cycle.
Sacituzumab Govitecan
Sacituzumab Govitecan is administered by IV on Day 1 and 8 of each 21-day cycle.
Radiation
Radiotherapy up to 21 days
Evolocumab
Evolocumab is administered subcutaneously at a dose of 140 mg on Days 1 and 15 of each 28-day cycle.
Tiragolumab
Tiragolumab is administered on Day 1 of each 21 day cycle.
XL092
XL092 is administered orally once a day on Day 1 to Day 21 of a 21 day cycle.
Camonsertib
Camonsertib is administered orally on Days 1-3, Days 8-10 of a 21 day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* No prior systemic therapy for metastatic NSCLC
* High tumor PD-L1 expression, defined as Tumor Proportion Score (TPS) or TCs \>= 50% or TC3
\- Disease progression during or following treatment for metastatic or locally advanced, inoperable NSCLC
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
Las Vegas, Nevada, United States
Columbia University Medical Center
New York, New York, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Blacktown Hospital
Blacktown, New South Wales, Australia
Peter Mac Callum Cancer Center
East Melbourne, Victoria, Australia
Centre Georges Francois Leclerc
Dijon, , France
Centre Léon Bérard
Lyon, , France
Hopital de la Timone
Marseille, , France
Institut Régional du Cancer de Montpellier
Montpellier, , France
Institut De Cancerologie De L'Ouest
Saint-Herblain, , France
Institut Universitaire du Cancer de Toulouse-Oncopole
Toulouse, , France
Rambam Medical Center
Haifa, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC)
Songpa-gu, , South Korea
Clínica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Fundación Jimenez Díaz
Madrid, , Spain
Hospital Universitario HM Sanchinarro-CIOCC
Madrid, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Barts Cancer Institute
London, , United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Royal Marsden Hospital
Sutton, , United Kingdom
Countries
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Other Identifiers
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2017-001267-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BO39610
Identifier Type: -
Identifier Source: org_study_id
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