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Immunotherapy Combination

Immunotherapy Combinations for Non-Small Cell Lung Cancer (Morpheus Lung Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed metastatic, non-squamous or squamous Non-Small Cell Lung Cancer (NSCLC)

Measurable disease (at least one target lesion)

Must not have

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

Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether immunotherapy-based treatment combinations can help patients with metastatic NSCLC. Two groups of patients will be enrolled, depending on whether they have received systemic therapy before. Treatment will be assigned based on eligibility.

Who is the study for?

This trial is for adults with metastatic non-small cell lung cancer. Cohort 1 includes those who haven't had systemic therapy and have high PD-L1 in tumors. Cohort 2 has patients whose disease progressed after platinum-based and PD-L1/PD-1 inhibitor treatments. Participants must be able to perform daily activities with minimal assistance, have a life expectancy of at least 3 months, measurable disease, proper organ function, and agree to use contraception.

What is being tested?

The study tests various immunotherapy combinations on two groups: one untreated for metastatic NSCLC (high tumor PD-L1 expression), the other previously treated but progressed. It assesses effectiveness, safety, and drug behavior in the body over two stages—initial treatment followed by an alternative if needed due to progression or side effects.

What are the potential side effects?

Potential side effects include immune-related reactions affecting organs, infusion responses similar to allergic reactions, fatigue, gastrointestinal issues like nausea or diarrhea, blood abnormalities that can affect clotting or immunity levels increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer is confirmed to be non-small cell type and has spread.

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I have at least one tumor that can be measured.

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My tumor can be easily reached for a biopsy.

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I agree to either not have sex or use birth control, and not donate sperm while on treatment.

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I have not received any systemic therapy for my metastatic NSCLC.

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My tumor shows high PD-L1 levels, with a score of 50% or more.

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My lung cancer has worsened despite treatment.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of certain lung conditions or signs of lung inflammation on a chest scan.

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I frequently need procedures to remove excess fluid from my body.

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I have brain metastases that are untreated or getting worse.

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I have had a condition where cancer spread to the lining of my brain and spinal cord.

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I have active tuberculosis.

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I have or had an autoimmune disease or immune deficiency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

23Treatment groups

Experimental Treatment

Active Control

Group I: Stage 2: Cohort 2: Atezolizumab + RO6958688Experimental Treatment3 Interventions

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

Group II: Stage 2: Cohort 2: Atezolizumab + LinagliptinExperimental Treatment2 Interventions

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

Group III: Stage 2: Cohort 2: Atezolizumab + DocetaxelExperimental Treatment2 Interventions

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.

Group IV: Stage 2: Cohort 1: Atezolizumab + Pemetrexed + CarboplatinExperimental Treatment3 Interventions

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

Group V: Stage 2: Cohort 1: Atezolizumab + Gemcitabine + CarboplatinExperimental Treatment3 Interventions

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

Group VI: Stage 1: Cohort 2: Atezolizumab + Sacituzumab GovitecanExperimental Treatment2 Interventions

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

Group VII: Stage 1: Cohort 2: Atezolizumab + RO6958688Experimental Treatment3 Interventions

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.

Group VIII: Stage 1: Cohort 2: Atezolizumab + IpatasertibExperimental Treatment2 Interventions

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.

Group IX: Stage 1: Cohort 2: Atezolizumab + EvolocumabExperimental Treatment2 Interventions

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

Group X: Stage 1: Cohort 2: Atezolizumab + DocetaxelExperimental Treatment2 Interventions

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.

Group XI: Stage 1: Cohort 2: Atezolizumab + CobimetinibExperimental Treatment2 Interventions

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.

Group XII: Stage 1: Cohort 2: Atezolizumab + CamonsertibExperimental Treatment2 Interventions

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

Group XIII: Stage 1: Cohort 2: Atezolizumab + CPI-444Experimental Treatment2 Interventions

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.

Group XIV: Stage 1: Cohort 2: Atezolizumab + Bevacizumab + TiragolumabExperimental Treatment3 Interventions

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

Group XV: Stage 1: Cohort 2: Atezolizumab + Bevacizumab + RadiotherapyExperimental Treatment3 Interventions

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

Group XVI: Stage 1: Cohort 2: Atezolizumab + Bevacizumab + CamonsertibExperimental Treatment3 Interventions

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

Group XVII: Stage 1: Cohort 2: Atezolizumab + BevacizumabExperimental Treatment2 Interventions

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.

Group XVIII: Stage 1: Cohort 1: Atezolizumab + Tiragolumab + XL092 (Zanzalintinib)Experimental Treatment3 Interventions

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

Group XIX: Stage 1: Cohort 1: Atezolizumab + RO6958688Experimental Treatment3 Interventions

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.

Group XX: Stage 1: Cohort 1: Atezolizumab + CobimetinibExperimental Treatment2 Interventions

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.

Group XXI: Stage 1: Cohort 2: DocetaxelActive Control1 Intervention

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.

Group XXII: Stage 1: Cohort 1: Atezolizumab + TiragolumabActive Control2 Interventions

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

Group XXIII: Stage 1: Cohort 1: AtezolizumabActive Control1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Tocilizumab

2012

Completed Phase 4

~1840

Ipatasertib

2017

Completed Phase 3

~3630