The trial is taking place at:
H

Hospital Regional Universitario de Malaga | Hospital Civil - Rheumatology Department

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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)

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Roche

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: XL092
Drug: Ipatasertib
Other: Radiation
Drug: RO6958688
Drug: Evolocumab
Drug: Pemetrexed
Drug: Camonsertib
Drug: Linagliptin
Drug: Cobimetinib
Drug: Sacituzumab Govitecan
Drug: Atezolizumab
Drug: Docetaxel
Drug: Carboplatin
Drug: Tiragolumab
Drug: CPI-444
Drug: Gemcitabine
Drug: Bevacizumab
Drug: Tocilizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT03337698
2017-001267-21 (EudraCT Number)
BO39610

Details and patient eligibility

About

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).

Enrollment

675 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

675 participants in 23 patient groups

Stage 1: Cohort 1: Atezolizumab
Active Comparator group
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.
Treatment:
Drug: Atezolizumab
Stage 1: Cohort 1: Atezolizumab + Cobimetinib
Experimental group
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.
Treatment:
Drug: Atezolizumab
Drug: Cobimetinib
Stage 1: Cohort 1: Atezolizumab + RO6958688
Experimental group
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.
Treatment:
Drug: Tocilizumab
Drug: Atezolizumab
Drug: RO6958688
Stage 1: Cohort 2: Docetaxel
Active Comparator group
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.
Treatment:
Drug: Docetaxel
Stage 1: Cohort 2: Atezolizumab + Cobimetinib
Experimental group
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.
Treatment:
Drug: Atezolizumab
Drug: Cobimetinib
Stage 1: Cohort 2: Atezolizumab + CPI-444
Experimental group
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.
Treatment:
Drug: CPI-444
Drug: Atezolizumab
Stage 1: Cohort 2: Atezolizumab + RO6958688
Experimental group
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.
Treatment:
Drug: Tocilizumab
Drug: Atezolizumab
Drug: RO6958688
Stage 1: Cohort 2: Atezolizumab + Ipatasertib
Experimental group
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.
Treatment:
Drug: Atezolizumab
Drug: Ipatasertib
Stage 1: Cohort 2: Atezolizumab + Docetaxel
Experimental group
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.
Treatment:
Drug: Docetaxel
Drug: Atezolizumab
Stage 1: Cohort 2: Atezolizumab + Bevacizumab
Experimental group
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.
Treatment:
Drug: Bevacizumab
Drug: Atezolizumab
Stage 2: Cohort 1: Atezolizumab + Pemetrexed + Carboplatin
Experimental group
Description:
Participants in the Atezolizumab + Pemetrexed + Carboplatin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Treatment:
Drug: Carboplatin
Drug: Atezolizumab
Drug: Pemetrexed
Stage 2: Cohort 1: Atezolizumab + Gemcitabine + Carboplatin
Experimental group
Description:
Participants in the Atezolizumab + Gemcitabine + Carboplatin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Treatment:
Drug: Gemcitabine
Drug: Carboplatin
Drug: Atezolizumab
Stage 2: Cohort 2: Atezolizumab + RO6958688
Experimental group
Description:
Participants in the Atezolizumab + RO6958688 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Treatment:
Drug: Tocilizumab
Drug: Atezolizumab
Drug: RO6958688
Stage 2: Cohort 2: Atezolizumab + Docetaxel
Experimental group
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.
Treatment:
Drug: Docetaxel
Drug: Atezolizumab
Stage 2: Cohort 2: Atezolizumab + Linagliptin
Experimental group
Description:
Participants in the Atezolizumab + Linagliptin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Treatment:
Drug: Atezolizumab
Drug: Linagliptin
Stage 1: Cohort 2: Atezolizumab + Sacituzumab Govitecan
Experimental group
Description:
Participants in the Atezolizumab + Sacituzumab Govitecan arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Treatment:
Drug: Sacituzumab Govitecan
Drug: Atezolizumab
Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy
Experimental group
Description:
Participants in the Atezolizumab + Bevacizumab + Radioatherapy arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Treatment:
Drug: Bevacizumab
Drug: Atezolizumab
Other: Radiation
Stage 1: Cohort 2: Atezolizumab + Evolocumab
Experimental group
Description:
Participants in the Atezolizumab + Evolocumab arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit.
Treatment:
Drug: Atezolizumab
Drug: Evolocumab
Stage 1: Cohort 1: Atezolizumab + Tiragolumab
Active Comparator group
Description:
Participants in the Atezolizumab + Tiragolumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Treatment:
Drug: Tiragolumab
Drug: Atezolizumab
Stage 1: Cohort 1: Atezolizumab + Tiragolumab + XL092 (Zanzalintinib)
Experimental group
Description:
Participants in the Atezolizumab + Tiragolumab + XL092 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Treatment:
Drug: Tiragolumab
Drug: Atezolizumab
Drug: XL092
Stage 1: Cohort 2: Atezolizumab + Camonsertib
Experimental group
Description:
Participants in the Atezolizumab + Camonsertib arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Treatment:
Drug: Atezolizumab
Drug: Camonsertib
Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Camonsertib
Experimental group
Description:
Participants in the Atezolizumab + Bevacizumab + Comonsertib arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Treatment:
Drug: Bevacizumab
Drug: Atezolizumab
Drug: Camonsertib
Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Tiragolumab
Experimental group
Description:
Participants in the Atezolizumab + Bevacizumab + Tiragolumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Treatment:
Drug: Bevacizumab
Drug: Tiragolumab
Drug: Atezolizumab

Trial contacts and locations

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Central trial contact

Reference Study ID Number: BO39610 https://forpatients.roche.com/

Data sourced from clinicaltrials.gov

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