A Phase 1 interventional study of MV-NIS and Atezolizumab in Recurrent Non-Small Cell Lung Cancer, sponsored by Vyriad, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-21.
Sponsored by Vyriad, Inc. · Phase 1, Interventional, and Treatment
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Among 3,366 studies in Carcinoma, Non-Small-Cell Lung with a site in United States — 519 open to participants now, 892 under way, 142 of them phase 3. Carcinoma, Non-Small-Cell Lung · United States.
Among the 3,366 studies in Carcinoma, Non-Small-Cell Lung with a site in United States, this one is the 2,852nd largest by enrollment of the 2,993 interventional ones that give a count, is one of 153 that started in 2017, is one of 926 in phase 1, and was the 1,780th registered.
7,621 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,836 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →519 of the 3,366 studies in Carcinoma, Non-Small-Cell Lung with a site in United States are open now. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 18+
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Sites in United States
Ages 18+
Indiana University · Sites in United States
Ages 18+
Exelixis · Sites in United States
Ages 18+
University of Chicago · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 1,327 Carcinoma, Non-Small-Cell Lung studies recruiting now, 989 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
3,366 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1,409 · Phase 2 1,590 · Phase 3 382 · Phase 4 13
First in 1990; this study’s year is marked. 153 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 2 is below the median of 62 across 6,020 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 56 across the 2,993 interventional studies, 100 across the 246 observational. Of the 2,297 that completed or were terminated, 1,053 (46%) have results posted.
This tab as a report to print or save as PDF → With an account.
1,735 of 3,366 have an industry lead sponsor. The 10 most frequent:
Vyriad, Inc. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Vyriad, Inc. has 2 studies filed under Carcinoma, Non-Small-Cell Lung — fewer than ten, so there is no comparison to draw.
270 of the studies in Carcinoma, Non-Small-Cell Lung with a site in United States that are under way reach primary completion within a year, 25 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05987956Phase 3Medicine Invention Design, IncPharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms | 2026-11-18 |
| NCT03815643Phase 3EMD Serono Research & Development Institute, Inc.Avelumab Program Rollover Study | 2026-11-24 |
| NCT04585490Phase 3Stanford UniversityAdaptive ctDNA-Based Personalization of Treatment During Consolidation Therapy in NSCLC | 2026-12 |
| NCT03637816Phase 3M.D. Anderson Cancer CenterAnamorelin Hydrochloride in Reducing Anorexia in Patients With Advanced Non-small Cell Lung Cancer | 2026-12-31 |
| NCT05221840Phase 3AstraZenecaA Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer | 2027-01-08 |
Add all 270 to your calendar (.ics) → With an account.
Among the 3,366 studies in Carcinoma, Non-Small-Cell Lung with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This a Phase 1 study designed to determine the maximum tolerated dose (MTD) and toxicity of attenuated Measles virus (MV-NIS) combined with Atezolizumab in patients with recurrent and metastatic NSCLC.
Phase 1, dose escalation study of the combination of intra-tumoral MV-NIS and systemic atezolizumab in patients with recurrent and metastatic NSCLC. After the dose escalation phase of the trial, a dose expansion cohort was planned to further investigate safety, clinical and immune responses at the MTD. A standard 3+3 design was to be used for the dose escalation part of the study. Starting at dose level 1, three patients were to be treated per dose level. MV-NIS was to be administered once intra-tumorally (IT) on Day 1 of treatment in 3 escalating dose cohorts, starting at dose level 1 x 10e8
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MV-NIS will be administered intratumorally as a single dose on day 1. Atezolizumab will be given at day 15 and then every 3 weeks.
Biological: MV-NIS · Biological: Atezolizumab
This is an open label single ascending dose phase I study designed to determine the safety profile and MTD after IT administration of a single dose of MV-NIS in combination with Atezolizumab in patients with metastatic NSCLC
Atezolizumab will be administered every 3 weeks
Maximum Tolerated Dose (MTD) of MV-NIS in Combination With Atezolizumab
To determine the maximum tolerated dose (MTD) of the intra-tumoral administration of an Edmonston strain MV genetically engineered to produce NIS (MV-NIS), in combination with the PD-L1 inhibitor atezolizumab
Time frame: 28 days after MV-NIS administration for each dose cohort
| Milestone | MV-NIS and Atezolizumab |
|---|---|
| Started | 2 |
| Completed | 0 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Investigator decision | 1 |
To determine the maximum tolerated dose (MTD) of the intra-tumoral administration of an Edmonston strain MV genetically engineered to produce NIS (MV-NIS), in combination with the PD-L1 inhibitor atezolizumab
No measurements were reported for this outcome.
Collected over AE data was collected from when the patient was enrolled in the study starting from the day of informed consent until 30 days after the last dose of study drug or the patient withdraws from the study. Event reporting occurred over a total period of 3 months (23August 2017-09Nov2017), the duration of the study.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MV-NIS and Atezolizumab | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Event | MV-NIS and Atezolizumab |
|---|---|
| ChillsInfections and infestations | 2/2 |
| Viral illnessInfections and infestations | 2/2 |
| PruritusSkin and subcutaneous tissue disorders | 2/2 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/2 |
| NausaGastrointestinal disorders | 1/2 |
| HeadacheNervous system disorders | 1/2 |
A maximum of 21 patients were planned for this study, 2 patients were treated prior to the closure of the study. The study was closed for administrative reasons.
| Age, Categorical(Participants) | MV-NIS and Atezolizumab |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | MV-NIS and Atezolizumab |
|---|---|
| Female | 1 |
| Male | 1 |
| Race (NIH/OMB)(Participants) | MV-NIS and Atezolizumab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2017 to primary completion in Jan 2018, 5 months.
Results were first posted in Jul 2023, 5 years 6 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung →
Vyriad, Inc.