Immunotherapy Combinations for Non-Small Cell Lung Cancer (Morpheus Lung Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: Hoffmann-La Roche
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?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).
Eligibility Criteria
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.Inclusion Criteria
My lung cancer is confirmed to be non-small cell type and has spread.
I have at least one tumor that can be measured.
My tumor can be easily reached for a biopsy.
I agree to either not have sex or use birth control, and not donate sperm while on treatment.
I have not received any systemic therapy for my metastatic NSCLC.
My tumor shows high PD-L1 levels, with a score of 50% or more.
My lung cancer has worsened despite treatment.
I am fully active or can carry out light work.
Exclusion Criteria
I have a history of certain lung conditions or signs of lung inflammation on a chest scan.
I frequently need procedures to remove excess fluid from my body.
I have brain metastases that are untreated or getting worse.
I have had a condition where cancer spread to the lining of my brain and spinal cord.
I have active tuberculosis.
I have or had an autoimmune disease or immune deficiency.
Treatment Details
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.
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.
Atezolizumab is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Tecentriq for:
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
🇪🇺 Approved in European Union as Tecentriq for:
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
Find a clinic near you
Research locations nearbySelect from list below to view details:
Columbia University Medical Center; Research Pharmacy, Irving Pavillion, Ip 7-749New York, NY
Comprehensive Cancer Centers of Nevada (CCCN) - Central ValleyLas Vegas, NV
SCRI Oncology PartnersNashville, TN
Christiana Care Health ServicesNewark, DE
More Trial Locations
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Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor