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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)

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Atezolizumab
Cobimetinib
RO6958688
Docetaxel
CPI-444
Pemetrexed
Carboplatin
Gemcitabine
Linagliptin
Tocilizumab
Ipatasertib
Bevacizumab
Sacituzumab Govitecan
Radiation
Evolocumab
Tiragolumab
XL092
Camonsertib
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • Availability of peripheral blood for next-generation sequencing (NGS) circulating tumor deoxyribonucleic acid (ctDNA) testing.
  • 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) >= 50%

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

Sites / Locations

  • Smilow Cancer Hospital at Yale New Haven
  • Christiana Care Health ServicesRecruiting
  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute
  • Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
  • Columbia University Medical Center; Research Pharmacy, Irving Pavillion, Ip 7-749
  • University Hospitals Case Medical Center; Seidman Cancer CenterRecruiting
  • Cleveland Clinic
  • Sarah Cannon Research Institute
  • Blacktown HospitalRecruiting
  • Peter Mac Callum Cancer Center
  • Centre Georges Francois LeclercRecruiting
  • Centre Léon Bérard
  • Hopital de la TimoneRecruiting
  • Institut Régional du Cancer de MontpellierRecruiting
  • Institut De Cancerologie De L'Ouest; Medical OncologyRecruiting
  • Institut Universitaire du Cancer de Toulouse-Oncopole; PHARMACIERecruiting
  • Rambam Medical Center; OncologyRecruiting
  • Rabin Medical CenterRecruiting
  • Chaim Sheba Medical Center; Oncology DeptRecruiting
  • Chonnam National University Hwasun Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Korea University Guro HospitalRecruiting
  • University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC)
  • Clínica Universidad de NavarraRecruiting
  • Hospital Universitari Vall d'HebronRecruiting
  • Hospital Universitario La PazRecruiting
  • Fundación Jimenez DíazRecruiting
  • Hospital Universitario HM Sanchinarro-CIOCCRecruiting
  • Hospital Regional Universitario de MalagaRecruiting
  • Hospital Clinico Universitario de ValenciaRecruiting
  • National Cheng Kung University Hospital; Gasterointestinal
  • Taipei Veterans General HospitalRecruiting
  • Barts Cancer InstituteRecruiting
  • The Newcastle upon Tyne Hospitals NHS Foundation TrustRecruiting
  • Royal Marsden Hospital; Institute of Cancer ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm 21

Arm Type

Active Comparator

Experimental

Experimental

Active Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Experimental

Experimental

Arm Label

Stage 1: Cohort 1: Atezolizumab

Stage 1: Cohort 1: Atezolizumab + Cobimetinib

Stage 1: Cohort 1: Atezolizumab + RO6958688

Stage 1: Cohort 2: Docetaxel

Stage 1: Cohort 2: Atezolizumab + Cobimetinib

Stage 1: Cohort 2: Atezolizumab + CPI-444

Stage 1: Cohort 2: Atezolizumab + RO6958688

Stage 1: Cohort 2: Atezolizumab + Ipatasertib

Stage 1: Cohort 2: Atezolizumab + Docetaxel

Stage 1: Cohort 2: Atezolizumab + Bevacizumab

Stage 2: Cohort 1: Atezolizumab + Pemetrexed + Carboplatin

Stage 2: Cohort 1: Atezolizumab + Gemcitabine + Carboplatin

Stage 2: Cohort 2: Atezolizumab + RO6958688

Stage 2: Cohort 2: Atezolizumab + Docetaxel

Stage 2: Cohort 2: Atezolizumab + Linagliptin

Stage 1: Cohort 2: Atezolizumab + Sacituzumab Govitecan

Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy

Stage 1: Cohort 2: Atezolizumab + Evolocumab

Stage 1: Cohort 1: Atezolizumab + Tiragolumab

Stage 1: Cohort 1: Atezolizumab + Tiragolumab + XL092 (Zanzalintinib)

Stage 1: Cohort 2: Atezolizumab + Camonsertib

Arm Description

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Participants in the Atezolizumab + Pemetrexed + Carboplatin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + Gemcitabine + Carboplatin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + RO6958688 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

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.

Participants in the Atezolizumab + Linagliptin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + Sacituzumab Govitecan arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + Bevacizumab + Radioatherapy arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + Evolocumab arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + Tiragolumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + Tiragolumab + XL092 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + Camonsertib arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Outcomes

Primary Outcome Measures

Percentage of Participants with Objective Response

Secondary Outcome Measures

Progression Free Survival (PFS)
Overall Survival After Randomization
Percentage of Participants Who Are Alive at Month 6 and at Month 12
Duration of Response
Disease Control
Percentage of Participants with Adverse Events

Full Information

First Posted
November 7, 2017
Last Updated
October 13, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT03337698
Brief Title
A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)
Acronym
Morpheus Lung
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
August 30, 2025 (Anticipated)
Study Completion Date
November 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
470 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stage 1: Cohort 1: Atezolizumab
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Stage 1: Cohort 1: Atezolizumab + Cobimetinib
Arm Type
Experimental
Arm Description
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.
Arm Title
Stage 1: Cohort 1: Atezolizumab + RO6958688
Arm Type
Experimental
Arm Description
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.
Arm Title
Stage 1: Cohort 2: Docetaxel
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Stage 1: Cohort 2: Atezolizumab + Cobimetinib
Arm Type
Experimental
Arm Description
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.
Arm Title
Stage 1: Cohort 2: Atezolizumab + CPI-444
Arm Type
Experimental
Arm Description
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.
Arm Title
Stage 1: Cohort 2: Atezolizumab + RO6958688
Arm Type
Experimental
Arm Description
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.
Arm Title
Stage 1: Cohort 2: Atezolizumab + Ipatasertib
Arm Type
Experimental
Arm Description
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.
Arm Title
Stage 1: Cohort 2: Atezolizumab + Docetaxel
Arm Type
Experimental
Arm Description
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.
Arm Title
Stage 1: Cohort 2: Atezolizumab + Bevacizumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Stage 2: Cohort 1: Atezolizumab + Pemetrexed + Carboplatin
Arm Type
Experimental
Arm Description
Participants in the Atezolizumab + Pemetrexed + Carboplatin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Arm Title
Stage 2: Cohort 1: Atezolizumab + Gemcitabine + Carboplatin
Arm Type
Experimental
Arm Description
Participants in the Atezolizumab + Gemcitabine + Carboplatin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Arm Title
Stage 2: Cohort 2: Atezolizumab + RO6958688
Arm Type
Experimental
Arm Description
Participants in the Atezolizumab + RO6958688 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Arm Title
Stage 2: Cohort 2: Atezolizumab + Docetaxel
Arm Type
Experimental
Arm Description
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.
Arm Title
Stage 2: Cohort 2: Atezolizumab + Linagliptin
Arm Type
Experimental
Arm Description
Participants in the Atezolizumab + Linagliptin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Arm Title
Stage 1: Cohort 2: Atezolizumab + Sacituzumab Govitecan
Arm Type
Experimental
Arm Description
Participants in the Atezolizumab + Sacituzumab Govitecan arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Arm Title
Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy
Arm Type
Experimental
Arm Description
Participants in the Atezolizumab + Bevacizumab + Radioatherapy arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Arm Title
Stage 1: Cohort 2: Atezolizumab + Evolocumab
Arm Type
Experimental
Arm Description
Participants in the Atezolizumab + Evolocumab arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit.
Arm Title
Stage 1: Cohort 1: Atezolizumab + Tiragolumab
Arm Type
Active Comparator
Arm Description
Participants in the Atezolizumab + Tiragolumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Arm Title
Stage 1: Cohort 1: Atezolizumab + Tiragolumab + XL092 (Zanzalintinib)
Arm Type
Experimental
Arm Description
Participants in the Atezolizumab + Tiragolumab + XL092 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Arm Title
Stage 1: Cohort 2: Atezolizumab + Camonsertib
Arm Type
Experimental
Arm Description
Participants in the Atezolizumab + Camonsertib arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Intervention Description
Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.
Intervention Type
Drug
Intervention Name(s)
Cobimetinib
Intervention Description
Cobimetinib is administered orally on Days 1-21 of a 28 day cycle.
Intervention Type
Drug
Intervention Name(s)
RO6958688
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Docetaxel is administered by IV on Day 1 of each 21 day cycle.
Intervention Type
Drug
Intervention Name(s)
CPI-444
Intervention Description
CPI-444 is administered orally twice daily on Days 1- 21, of a 21 day cycle.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Pemetrexed is administered by IV on Day 1 of a 21 day cycle.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin is administered by IV on day 1 of the first 4 or 6 cycles out of a 21 day cycle.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine is administered by IV on Days 1 and 8 of the first 4 or 6 cycles out of a 21 day cycle.
Intervention Type
Drug
Intervention Name(s)
Linagliptin
Intervention Description
Linagliptin is administered orally once daily on Days 1 to 21 out of a 21 day cycle.
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Intervention Description
Tocilizumab is administered for the management of cytokine-release syndrome in the RO6958688-containing arms.
Intervention Type
Drug
Intervention Name(s)
Ipatasertib
Intervention Description
Ipatasertib will be administered orally once a day on Days 1-21 of each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
Bevacizumab is administered by IV on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Sacituzumab Govitecan
Intervention Description
Sacituzumab Govitecan is administered by IV on Day 1 and 8 of each 21-day cycle.
Intervention Type
Other
Intervention Name(s)
Radiation
Intervention Description
Radiotherapy up to 21 days
Intervention Type
Drug
Intervention Name(s)
Evolocumab
Intervention Description
Evolocumab is administered subcutaneously at a dose of 140 mg on Days 1 and 15 of each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Tiragolumab
Intervention Description
Tiragolumab is administered on Day 1 of each 21 day cycle.
Intervention Type
Drug
Intervention Name(s)
XL092
Other Intervention Name(s)
Zanzalintinib
Intervention Description
XL092 is administered orally once a day on Day 1 to Day 21 of a 21 day cycle.
Intervention Type
Drug
Intervention Name(s)
Camonsertib
Intervention Description
Camonsertib is administered orally on Days 1-3, Days 8-10 of a 21 day cycle.
Primary Outcome Measure Information:
Title
Percentage of Participants with Objective Response
Time Frame
Every 6 weeks (starting on Day 1, Cycle 1) for the first 48 weeks and then every 6 or 12 weeks thereafter
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Time Frame
Randomization to the first occurrence of disease progression or death from any cause (up to approximately 7 years)
Title
Overall Survival After Randomization
Time Frame
Randomization to death from any cause (up to approximately 7 years)
Title
Percentage of Participants Who Are Alive at Month 6 and at Month 12
Time Frame
Month 6, Month 12
Title
Duration of Response
Time Frame
First occurrence of a documented objective response to disease progression or death (up to approximately 7 years)
Title
Disease Control
Time Frame
Randomization to the first occurrence of disease progression or death from any cause (up to approximately 7 years)
Title
Percentage of Participants with Adverse Events
Time Frame
Baseline through the end of the study (approximately 7 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: BO39610 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. and Canada)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Smilow Cancer Hospital at Yale New Haven
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Completed
Facility Name
Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Withdrawn
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Completed
Facility Name
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Individual Site Status
Completed
Facility Name
Columbia University Medical Center; Research Pharmacy, Irving Pavillion, Ip 7-749
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Completed
Facility Name
University Hospitals Case Medical Center; Seidman Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Withdrawn
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Completed
Facility Name
Blacktown Hospital
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Individual Site Status
Recruiting
Facility Name
Peter Mac Callum Cancer Center
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Completed
Facility Name
Centre Georges Francois Leclerc
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Completed
Facility Name
Hopital de la Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Régional du Cancer de Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Name
Institut De Cancerologie De L'Ouest; Medical Oncology
City
Saint Herblain
ZIP/Postal Code
44115
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Universitaire du Cancer de Toulouse-Oncopole; PHARMACIE
City
Toulouse
ZIP/Postal Code
31100
Country
France
Individual Site Status
Recruiting
Facility Name
Rambam Medical Center; Oncology
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
4922297
Country
Israel
Individual Site Status
Recruiting
Facility Name
Chaim Sheba Medical Center; Oncology Dept
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Chonnam National University Hwasun Hospital
City
Jeollanam-do
ZIP/Postal Code
58128
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC)
City
Songpa-gu
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Clínica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31620
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
280146
Country
Spain
Individual Site Status
Recruiting
Facility Name
Fundación Jimenez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario HM Sanchinarro-CIOCC
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Regional Universitario de Malaga
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital; Gasterointestinal
City
Tainan City
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Completed
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Barts Cancer Institute
City
London
ZIP/Postal Code
E1 2AT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Newcastle upon Tyne Hospitals NHS Foundation Trust
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Marsden Hospital; Institute of Cancer Research
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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