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

Part of paid clinical trials in Las Vegas, Nevada.

Sponsor
Hoffmann-La Roche
Study ID
NCT03337698
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    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 — DRUG
    Cobimetinib is administered orally on Days 1-21 of a 28 day cycle.
  • RO6958688 — DRUG
    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 — DRUG
    Docetaxel is administered by IV on Day 1 of each 21 day cycle.
  • CPI-444 — DRUG
    CPI-444 is administered orally twice daily on Days 1- 21, of a 21 day cycle.
  • Pemetrexed — DRUG
    Pemetrexed is administered by IV on Day 1 of a 21 day cycle.
  • Carboplatin — DRUG
    Carboplatin is administered by IV on day 1 of the first 4 or 6 cycles out of a 21 day cycle.
  • Gemcitabine — DRUG
    Gemcitabine is administered by IV on Days 1 and 8 of the first 4 or 6 cycles out of a 21 day cycle.
  • Linagliptin — DRUG
    Linagliptin is administered orally once daily on Days 1 to 21 out of a 21 day cycle.
  • Tocilizumab — DRUG
    Tocilizumab is administered for the management of cytokine-release syndrome in the RO6958688-containing arms.
  • Ipatasertib — DRUG
    Ipatasertib will be administered orally once a day on Days 1-21 of each 28-day cycle.
  • Bevacizumab — DRUG
    Bevacizumab is administered by IV on Day 1 of each 21-day cycle.
  • Sacituzumab Govitecan — DRUG
    Sacituzumab Govitecan is administered by IV on Day 1 and 8 of each 21-day cycle.
  • Radiation — OTHER
    Radiotherapy up to 21 days
  • Evolocumab — DRUG
    Evolocumab is administered subcutaneously at a dose of 140 mg on Days 1 and 15 of each 28-day cycle.
  • Tiragolumab — DRUG
    Tiragolumab is administered on Day 1 of each 21 day cycle.
  • XL092 — DRUG
    XL092 is administered orally once a day on Day 1 to Day 21 of a 21 day cycle.
  • Camonsertib — DRUG
    Camonsertib is administered orally on Days 1-3, Days 8-10 of a 21 day cycle.

Study Details

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).

Key Dates

Start date
Dec 27, 2017
Status verified
Apr 2026
Primary completion
Oct 14, 2025
Completion
Nov 25, 2025

Study Design

Enrollment
314 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Active Comparator: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Active Comparator: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Stage 1: Percentage of Participants With Objective Response (OR) as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1) [ Time Frame: Up to 50.4 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
Comprehensive Cancer Centers of Nevada (CCCN) - Central ValleyLas VegasNevada89169-
Columbia University Medical CenterNew YorkNew York10032-
University Hospitals Case Medical CenterClevelandOhio44106-
SCRI Oncology PartnersNashvilleTennessee37203-

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By research site
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley· Las Vegas, NVColumbia University Medical Center· New York, NYUniversity Hospitals Case Medical Center· Cleveland, OHSCRI Oncology Partners· Nashville, TN

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