Carcinoma, Non-Small-Cell LungPhase 1/2Morpheus LungNCT03337698
A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)
A Phase 1/2 study testing Atezolizumab, Cobimetinib and RO6958688 in people with Carcinoma, Non-Small-Cell Lung, run by Hoffmann-La Roche at 29 sites in 7 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Atezolizumab, Cobimetinib and RO6958688
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 29 sitesin 7 countries
- Study dates
- 27 Dec 2017to 25 Nov 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No prior systemic therapy for metastatic NSCLC
- High tumor PD-L1 expression, defined as Tumor Proportion Score (TPS) or TCs >= 50% or TC3
- Disease progression during or following treatment for metastatic or locally advanced, inoperable NSCLC
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
29 sites in 7 countries.
29 sites in 7 countries
Spain7 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Universitario La Paz
Madrid, 280146
Fundación Jimenez Díaz
Madrid, 28040
Hospital Universitario HM Sanchinarro-CIOCC
Madrid, 28050
Hospital Regional Universitario de Malaga
Málaga, 29010
Clínica Universidad de Navarra
Pamplona, Navarre, 31008
Hospital Clinico Universitario de Valencia
Valencia, 46010
France6 sites
Centre Georges Francois Leclerc
Dijon, 21079
Centre Léon Bérard
Lyon, 69008
Hopital de la Timone
Marseille, 13005
Institut Régional du Cancer de Montpellier
Montpellier, 34298
Institut De Cancerologie De L'Ouest
Saint-Herblain, 44115
Institut Universitaire du Cancer de Toulouse-Oncopole
Toulouse, 31100
United States4 sites
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
Las Vegas, Nevada, 89169
SCRI Oncology Partners
Nashville, Tennessee, 37203
Columbia University Medical Center
New York, New York, 10032
South Korea4 sites
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea University Guro Hospital
Seoul, 08308
University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC)
Songpa-gu, 05505
Israel3 sites
Rambam Medical Center
Haifa, 3109601
Rabin Medical Center
Petah Tikva, 4941492
Chaim Sheba Medical Center
Ramat Gan, 52620-00
United Kingdom3 sites
Barts Cancer Institute
London, E1 2AT
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE1 4LP
Royal Marsden Hospital
Sutton, SM2 5PT
Australia2 sites
Blacktown Hospital
Blacktown, New South Wales, 2148
Peter Mac Callum Cancer Center
East Melbourne, Victoria, 3002
About this study
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)
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).
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Atezolizumab, Cobimetinib, RO6958688, Docetaxel, CPI-444
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.
CobimetinibDrug
Cobimetinib is administered orally on Days 1-21 of a 28 day cycle.
RO6958688Drug
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.
DocetaxelDrug
Docetaxel is administered by IV on Day 1 of each 21 day cycle.
CPI-444Drug
CPI-444 is administered orally twice daily on Days 1- 21, of a 21 day cycle.
PemetrexedDrug
Pemetrexed is administered by IV on Day 1 of a 21 day cycle.
CarboplatinDrug
Carboplatin is administered by IV on day 1 of the first 4 or 6 cycles out of a 21 day cycle.
GemcitabineDrug
Gemcitabine is administered by IV on Days 1 and 8 of the first 4 or 6 cycles out of a 21 day cycle.
LinagliptinDrug
Linagliptin is administered orally once daily on Days 1 to 21 out of a 21 day cycle.
TocilizumabDrug
Tocilizumab is administered for the management of cytokine-release syndrome in the RO6958688-containing arms.
IpatasertibDrug
Ipatasertib will be administered orally once a day on Days 1-21 of each 28-day cycle.
BevacizumabDrug
Bevacizumab is administered by IV on Day 1 of each 21-day cycle.
Sacituzumab GovitecanDrug
Sacituzumab Govitecan is administered by IV on Day 1 and 8 of each 21-day cycle.
RadiationOther
Radiotherapy up to 21 days
EvolocumabDrug
Evolocumab is administered subcutaneously at a dose of 140 mg on Days 1 and 15 of each 28-day cycle.
TiragolumabDrug
Tiragolumab is administered on Day 1 of each 21 day cycle.
XL092Drug
Also called Zanzalintinib
XL092 is administered orally once a day on Day 1 to Day 21 of a 21 day cycle.
CamonsertibDrug
Camonsertib is administered orally on Days 1-3, Days 8-10 of a 21 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1: Cohort 1: Atezolizumab | Active comparator | 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. Receives: Drug: Atezolizumab |
| Stage 1: Cohort 1: Atezolizumab + Cobimetinib | Experimental | 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. Receives: Drug: Atezolizumab; Drug: Cobimetinib |
| Stage 1: Cohort 1: Atezolizumab + RO6958688 | Experimental | 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. Receives: Drug: Atezolizumab; Drug: RO6958688; Drug: Tocilizumab |
| Stage 1: Cohort 2: Docetaxel | Active comparator | 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. Receives: Drug: Docetaxel |
| Stage 1: Cohort 2: Atezolizumab + Cobimetinib | Experimental | 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. Receives: Drug: Atezolizumab; Drug: Cobimetinib |
| Stage 1: Cohort 2: Atezolizumab + CPI-444 | Experimental | 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. Receives: Drug: Atezolizumab; Drug: CPI-444 |
| Stage 1: Cohort 2: Atezolizumab + RO6958688 | Experimental | 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. Receives: Drug: Atezolizumab; Drug: RO6958688; Drug: Tocilizumab |
| Stage 1: Cohort 2: Atezolizumab + Ipatasertib | Experimental | 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. Receives: Drug: Atezolizumab; Drug: Ipatasertib |
| Stage 1: Cohort 2: Atezolizumab + Docetaxel | Experimental | 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. Receives: Drug: Atezolizumab; Drug: Docetaxel |
| Stage 1: Cohort 2: Atezolizumab + Bevacizumab | Experimental | 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. Receives: Drug: Atezolizumab; Drug: Bevacizumab |
| Stage 2: Cohort 1: Atezolizumab + Pemetrexed + Carboplatin | Experimental | Participants in the Atezolizumab + Pemetrexed + Carboplatin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Receives: Drug: Atezolizumab; Drug: Pemetrexed; Drug: Carboplatin |
| Stage 2: Cohort 1: Atezolizumab + Gemcitabine + Carboplatin | Experimental | Participants in the Atezolizumab + Gemcitabine + Carboplatin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Receives: Drug: Atezolizumab; Drug: Carboplatin; Drug: Gemcitabine |
| Stage 2: Cohort 2: Atezolizumab + RO6958688 | Experimental | Participants in the Atezolizumab + RO6958688 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Receives: Drug: Atezolizumab; Drug: RO6958688; Drug: Tocilizumab |
| Stage 2: Cohort 2: Atezolizumab + Docetaxel | Experimental | 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. Receives: Drug: Atezolizumab; Drug: Docetaxel |
| Stage 2: Cohort 2: Atezolizumab + Linagliptin | Experimental | Participants in the Atezolizumab + Linagliptin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Receives: Drug: Atezolizumab; Drug: Linagliptin |
| Stage 1: Cohort 2: Atezolizumab + Sacituzumab Govitecan | Experimental | Participants in the Atezolizumab + Sacituzumab Govitecan arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Receives: Drug: Atezolizumab; Drug: Sacituzumab Govitecan |
| Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy | Experimental | Participants in the Atezolizumab + Bevacizumab + Radioatherapy arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Receives: Drug: Atezolizumab; Drug: Bevacizumab; Other: Radiation |
| Stage 1: Cohort 2: Atezolizumab + Evolocumab | Experimental | Participants in the Atezolizumab + Evolocumab arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit. Receives: Drug: Atezolizumab; Drug: Evolocumab |
| Stage 1: Cohort 1: Atezolizumab + Tiragolumab | Active comparator | Participants in the Atezolizumab + Tiragolumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Receives: Drug: Atezolizumab; Drug: Tiragolumab |
| Stage 1: Cohort 1: Atezolizumab + Tiragolumab + XL092 (Zanzalintinib) | Experimental | Participants in the Atezolizumab + Tiragolumab + XL092 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Receives: Drug: Atezolizumab; Drug: Tiragolumab; Drug: XL092 |
| Stage 1: Cohort 2: Atezolizumab + Camonsertib | Experimental | Participants in the Atezolizumab + Camonsertib arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Receives: Drug: Atezolizumab; Drug: Camonsertib |
| Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Camonsertib | Experimental | Participants in the Atezolizumab + Bevacizumab + Comonsertib arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Receives: Drug: Atezolizumab; Drug: Bevacizumab; Drug: Camonsertib |
| Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Tiragolumab | Experimental | Participants in the Atezolizumab + Bevacizumab + Tiragolumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Receives: Drug: Atezolizumab; Drug: Bevacizumab; Drug: Tiragolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
OR was defined as a complete response (CR) or partial response (PR) on two consecutive occasions, ≥4 weeks apart, during Stage 1 as determined by the investigator using RECIST v.1.1. Objective response rate (ORR) was defined as the percentage of participants with OR. CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. 95% confidence intervals (CI) for rates were constructed using Clopper-Pearson method. Percentages have been rounded off. The participant in the 'Stage 1 Cohort 2 (S1C2): Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.
Measured: Up to 50.4 months
Secondary outcomes (7)
Stage 1: Progression-free Survival (PFS) as Determined by Investigator According to RECIST V1.1
PFS was defined as the time from study treatment initiation to the first occurrence of documented PD, as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. Participants who did not have documented PD or death, PFS was censored at the day of the last tumor assessment. Kaplan-Meier (K-M) method was used to estimate PFS. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.
Measured: From randomization to the first occurrence of PD or death (Up to 48.6 months)
Stage 1: PFS Rate at Month 6
PFS was defined as the time from study treatment initiation to the first occurrence of documented PD, as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. Participants who did not have documented PD or death, PFS was censored at the day of the last tumor assessment. The KM approach was used to estimate the percentage of participants who were event-free for PFS at Month 6. Percentages have been rounded off. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.
Measured: At Month 6
Stage 1: Overall Survival (OS)
OS was defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. K-M method was used to estimate OS. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.
Measured: From randomization to death (Up to 67 months)
Stage 1: OS Rate at Month 6
OS was defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. The Kaplan-Meier approach was used to estimate the percentage of participants who were event-free for OS at Month 6. Percentages have been rounded off. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.
Measured: At Month 6
Stage 1: Duration of Response (DOR), as Determined by Investigator According to RECIST V1.1
DOR was defined as the time from the first occurrence of a documented OR until the time of documented PD or death from any cause, whichever occurred first as per investigator assessment using RECIST v1.1. DOR was calculated for participants who had a best confirmed OR of CR/PR. CR and PR were defined as outlined in the description for ORR outcome measure. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. Participants who did not have documented PD or death, DOR was censored at the day of the last tumor assessment. K-M method was used to estimate DOR. The participant in the 'S1C2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.
Measured: From first occurrence of a documented OR until the time of documented PD or death (Up to 50.4 months)
Stage 1: Percentage of Participants With Disease Control (DC), as Determined by Investigator According to RECIST V1.1
DC was defined as stable disease (SD) for ≥ 12 weeks or a CR or PR, as determined by the investigator according to RECIST v1.1 Disease control rate (DCR) was defined as the percentage of participants with DC. CR was defined as the disappearance of all target \& non-target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. Percentages have been rounded off.
Measured: Up to 50.4 months
Stages 1 and 2: Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAEs = Serious AEs; AESIs = Adverse Events of Special Interest.
Measured: From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start27 Dec 2017
- Primary completion14 Oct 2025
- Study completion25 Nov 2025
Why it stopped: Study was closed early as the sponsor decided not to continue development of certain treatment combinations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337698
- Sponsor's protocol ID
- BO39610
- Other IDs
- 2017-001267-21, 2017
- Acronym
- Morpheus Lung
- Status last verified
- Apr 2026
- First submitted
- 7 Nov 2017
- Last updated
- 12 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03337698
- Acronym / sponsor ID
- Morpheus Lung / BO39610
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was closed early as the sponsor decided not to continue development of certain treatment combinations.
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2017 (actual)
- Primary completion
- 14 Oct 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 9 Nov 2017 (actual)
- Results
- Posted 12 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 23
| Arm | Type | Receives |
|---|---|---|
| Stage 1: Cohort 1: Atezolizumab | Active comparator | Drug: AtezolizumabParticipants 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. |
| Stage 1: Cohort 1: Atezolizumab + Cobimetinib | Experimental | Drug: Atezolizumab, Drug: CobimetinibParticipants 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. |
| Stage 1: Cohort 1: Atezolizumab + RO6958688 | Experimental | Drug: Atezolizumab, Drug: RO6958688, Drug: TocilizumabParticipants 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. |
| Stage 1: Cohort 2: Docetaxel | Active comparator | Drug: DocetaxelParticipants 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. |
| Stage 1: Cohort 2: Atezolizumab + Cobimetinib | Experimental | Drug: Atezolizumab, Drug: CobimetinibParticipants 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. |
| Stage 1: Cohort 2: Atezolizumab + CPI-444 | Experimental | Drug: Atezolizumab, Drug: CPI-444Participants 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. |
| Stage 1: Cohort 2: Atezolizumab + RO6958688 | Experimental | Drug: Atezolizumab, Drug: RO6958688, Drug: TocilizumabParticipants 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. |
| Stage 1: Cohort 2: Atezolizumab + Ipatasertib | Experimental | Drug: Atezolizumab, Drug: IpatasertibParticipants 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. |
| Stage 1: Cohort 2: Atezolizumab + Docetaxel | Experimental | Drug: Atezolizumab, Drug: DocetaxelParticipants 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. |
| Stage 1: Cohort 2: Atezolizumab + Bevacizumab | Experimental | Drug: Atezolizumab, Drug: BevacizumabParticipants 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. |
| Stage 2: Cohort 1: Atezolizumab + Pemetrexed + Carboplatin | Experimental | Drug: Atezolizumab, Drug: Pemetrexed, Drug: CarboplatinParticipants in the Atezolizumab + Pemetrexed + Carboplatin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. |
| Stage 2: Cohort 1: Atezolizumab + Gemcitabine + Carboplatin | Experimental | Drug: Atezolizumab, Drug: Carboplatin, Drug: GemcitabineParticipants in the Atezolizumab + Gemcitabine + Carboplatin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. |
| Stage 2: Cohort 2: Atezolizumab + RO6958688 | Experimental | Drug: Atezolizumab, Drug: RO6958688, Drug: TocilizumabParticipants in the Atezolizumab + RO6958688 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. |
| Stage 2: Cohort 2: Atezolizumab + Docetaxel | Experimental | Drug: Atezolizumab, Drug: DocetaxelParticipants 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. |
| Stage 2: Cohort 2: Atezolizumab + Linagliptin | Experimental | Drug: Atezolizumab, Drug: LinagliptinParticipants in the Atezolizumab + Linagliptin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. |
| Stage 1: Cohort 2: Atezolizumab + Sacituzumab Govitecan | Experimental | Drug: Atezolizumab, Drug: Sacituzumab GovitecanParticipants in the Atezolizumab + Sacituzumab Govitecan arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. |
| Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy | Experimental | Drug: Atezolizumab, Drug: Bevacizumab, Other: RadiationParticipants in the Atezolizumab + Bevacizumab + Radioatherapy arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. |
| Stage 1: Cohort 2: Atezolizumab + Evolocumab | Experimental | Drug: Atezolizumab, Drug: EvolocumabParticipants in the Atezolizumab + Evolocumab arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit. |
| Stage 1: Cohort 1: Atezolizumab + Tiragolumab | Active comparator | Drug: Atezolizumab, Drug: TiragolumabParticipants in the Atezolizumab + Tiragolumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. |
| Stage 1: Cohort 1: Atezolizumab + Tiragolumab + XL092 (Zanzalintinib) | Experimental | Drug: Atezolizumab, Drug: Tiragolumab, Drug: XL092Participants in the Atezolizumab + Tiragolumab + XL092 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. |
| Stage 1: Cohort 2: Atezolizumab + Camonsertib | Experimental | Drug: Atezolizumab, Drug: CamonsertibParticipants in the Atezolizumab + Camonsertib arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. |
| Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Camonsertib | Experimental | Drug: Atezolizumab, Drug: Bevacizumab, Drug: CamonsertibParticipants in the Atezolizumab + Bevacizumab + Comonsertib arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. |
| Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Tiragolumab | Experimental | Drug: Atezolizumab, Drug: Bevacizumab, Drug: TiragolumabParticipants in the Atezolizumab + Bevacizumab + Tiragolumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- No prior systemic therapy for metastatic NSCLC
- High tumor PD-L1 expression, defined as Tumor Proportion Score (TPS) or TCs >= 50% or TC3
- Disease progression during or following treatment for metastatic or locally advanced, inoperable NSCLC
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtezolizumabAtezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle. | Drug | Stage 1: Cohort 1: Atezolizumab, Stage 1: Cohort 1: Atezolizumab + Cobimetinib, Stage 1: Cohort 1: Atezolizumab + RO6958688, Stage 1: Cohort 1: Atezolizumab + Tiragolumab, Stage 1: Cohort 1: Atezolizumab + Tiragolumab + XL092 (Zanzalintinib), Stage 1: Cohort 2: Atezolizumab + Bevacizumab, Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Camonsertib, Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy, Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Tiragolumab, Stage 1: Cohort 2: Atezolizumab + CPI-444, Stage 1: Cohort 2: Atezolizumab + Camonsertib, Stage 1: Cohort 2: Atezolizumab + Cobimetinib, Stage 1: Cohort 2: Atezolizumab + Docetaxel, Stage 1: Cohort 2: Atezolizumab + Evolocumab, Stage 1: Cohort 2: Atezolizumab + Ipatasertib, Stage 1: Cohort 2: Atezolizumab + RO6958688, Stage 1: Cohort 2: Atezolizumab + Sacituzumab Govitecan, Stage 2: Cohort 1: Atezolizumab + Gemcitabine + Carboplatin, Stage 2: Cohort 1: Atezolizumab + Pemetrexed + Carboplatin, Stage 2: Cohort 2: Atezolizumab + Docetaxel, Stage 2: Cohort 2: Atezolizumab + Linagliptin, Stage 2: Cohort 2: Atezolizumab + RO6958688 |
| CobimetinibCobimetinib is administered orally on Days 1-21 of a 28 day cycle. | Drug | Stage 1: Cohort 1: Atezolizumab + Cobimetinib, Stage 1: Cohort 2: Atezolizumab + Cobimetinib |
| RO6958688Cycle 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. | Drug | Stage 1: Cohort 1: Atezolizumab + RO6958688, Stage 1: Cohort 2: Atezolizumab + RO6958688, Stage 2: Cohort 2: Atezolizumab + RO6958688 |
| DocetaxelDocetaxel is administered by IV on Day 1 of each 21 day cycle. | Drug | Stage 1: Cohort 2: Atezolizumab + Docetaxel, Stage 1: Cohort 2: Docetaxel, Stage 2: Cohort 2: Atezolizumab + Docetaxel |
| CPI-444CPI-444 is administered orally twice daily on Days 1- 21, of a 21 day cycle. | Drug | Stage 1: Cohort 2: Atezolizumab + CPI-444 |
| PemetrexedPemetrexed is administered by IV on Day 1 of a 21 day cycle. | Drug | Stage 2: Cohort 1: Atezolizumab + Pemetrexed + Carboplatin |
| CarboplatinCarboplatin is administered by IV on day 1 of the first 4 or 6 cycles out of a 21 day cycle. | Drug | Stage 2: Cohort 1: Atezolizumab + Gemcitabine + Carboplatin, Stage 2: Cohort 1: Atezolizumab + Pemetrexed + Carboplatin |
| GemcitabineGemcitabine is administered by IV on Days 1 and 8 of the first 4 or 6 cycles out of a 21 day cycle. | Drug | Stage 2: Cohort 1: Atezolizumab + Gemcitabine + Carboplatin |
| LinagliptinLinagliptin is administered orally once daily on Days 1 to 21 out of a 21 day cycle. | Drug | Stage 2: Cohort 2: Atezolizumab + Linagliptin |
| TocilizumabTocilizumab is administered for the management of cytokine-release syndrome in the RO6958688-containing arms. | Drug | Stage 1: Cohort 1: Atezolizumab + RO6958688, Stage 1: Cohort 2: Atezolizumab + RO6958688, Stage 2: Cohort 2: Atezolizumab + RO6958688 |
| IpatasertibIpatasertib will be administered orally once a day on Days 1-21 of each 28-day cycle. | Drug | Stage 1: Cohort 2: Atezolizumab + Ipatasertib |
| BevacizumabBevacizumab is administered by IV on Day 1 of each 21-day cycle. | Drug | Stage 1: Cohort 2: Atezolizumab + Bevacizumab, Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Camonsertib, Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy, Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Tiragolumab |
| Sacituzumab GovitecanSacituzumab Govitecan is administered by IV on Day 1 and 8 of each 21-day cycle. | Drug | Stage 1: Cohort 2: Atezolizumab + Sacituzumab Govitecan |
| RadiationRadiotherapy up to 21 days | Other | Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy |
| EvolocumabEvolocumab is administered subcutaneously at a dose of 140 mg on Days 1 and 15 of each 28-day cycle. | Drug | Stage 1: Cohort 2: Atezolizumab + Evolocumab |
| TiragolumabTiragolumab is administered on Day 1 of each 21 day cycle. | Drug | Stage 1: Cohort 1: Atezolizumab + Tiragolumab, Stage 1: Cohort 1: Atezolizumab + Tiragolumab + XL092 (Zanzalintinib), Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Tiragolumab |
| XL092Also: ZanzalintinibXL092 is administered orally once a day on Day 1 to Day 21 of a 21 day cycle. | Drug | Stage 1: Cohort 1: Atezolizumab + Tiragolumab + XL092 (Zanzalintinib) |
| CamonsertibCamonsertib is administered orally on Days 1-3, Days 8-10 of a 21 day cycle. | Drug | Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Camonsertib, Stage 1: Cohort 2: Atezolizumab + Camonsertib |
Primary outcome
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
OR was defined as a complete response (CR) or partial response (PR) on two consecutive occasions, ≥4 weeks apart, during Stage 1 as determined by the investigator using RECIST v.1.1. Objective response rate (ORR) was defined as the percentage of participants with OR. CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. 95% confidence intervals (CI) for rates were constructed using Clopper-Pearson method. Percentages have been rounded off. The participant in the 'Stage 1 Cohort 2 (S1C2): Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.
7 secondary outcomes
Stage 1: Progression-free Survival (PFS) as Determined by Investigator According to RECIST V1.1
Time frame: From randomization to the first occurrence of PD or death (Up to 48.6 months)
Stage 1: PFS Rate at Month 6
Time frame: At Month 6
Stage 1: Overall Survival (OS)
Time frame: From randomization to death (Up to 67 months)
Stage 1: OS Rate at Month 6
Time frame: At Month 6
Stage 1: Duration of Response (DOR), as Determined by Investigator According to RECIST V1.1
Time frame: From first occurrence of a documented OR until the time of documented PD or death (Up to 50.4 months)
Stage 1: Percentage of Participants With Disease Control (DC), as Determined by Investigator According to RECIST V1.1
Time frame: Up to 50.4 months
Stages 1 and 2: Number of Participants With Adverse Events (AEs)
Time frame: From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
29 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Atezolizumab, Cobimetinib and RO6958688 in people with Carcinoma, Non-Small-Cell Lung, run by Hoffmann-La Roche at 29 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Spain, France, United States, South Korea, Israel and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.