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Recurrent Non-Small Cell Lung CarcinomaPhase 2NCT02823990

TG4010 and Nivolumab in Patients With Lung Cancer

A Phase 2 study testing TG4010 and Nivolumab in people with Recurrent Non-Small Cell Lung Carcinoma and Stage I Non-Small Cell Lung Cancer, run by Megan Daly, MD at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial studies how well TG4010 and nivolumab work in previously treated patients with non-small cell lung cancer. Vaccines that are made from a gene-modified virus, such as TG4010, may help the body build an effective immune response to kill tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TG4010 and Nivolumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
4 sitesUnited States
Study dates
14 Dec 2016to 24 Feb 2021
Phase
Phase 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

  • Histologically confirmed non-squamous NSCLC; patients with adenocarcinoma must have had epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) mutational testing; those with an actionable mutations/rearrangements are excluded
  • Stage IIIB or IV patients must have progressed after a platinum based chemotherapy; a maximum of 3 previous systemic regimens are allowed (one regimen can be a tyrosine kinase inhibitor); patients with stage I-IIIB NSCLC who have progressed within 6 months of a full dose platinum based regimen as adjuvant therapy or with radiotherapy are eligible; patients who received weekly low dose chemotherapy with radiation only are not eligible
  • At least one measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) based on RECIST version 1.1
  • Performance status (PS) 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
  • Minimum life expectancy of 3 months
  • Hemoglobin >= 10.0 g/dL
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  • White blood cells (WBC) >= 3.0 x 10^9/L
  • Neutrophils >= 1.5 x 10^9/L
  • Total lymphocyte count >= 0.5 x 10^9/L
  • Platelet counts >= 100 x 10^9/L
  • Serum alkaline phosphatase =< 3 x upper limit of normal (ULN) in absence of liver or bone metastases and =< 5 x ULN in patients with documented bone or liver metastases
  • Total bilirubin =< 1.5 x ULN
  • Serum transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) =< 2.5 x ULN in the absence of liver metastases and =< 5 x ULN in case of liver metastases
  • Glomerular Filtration Rate >= 60 mL/min (according to Modification of Diet in Renal Disease [MDRD] formula or Cockcroft \& Gault formula)
  • Serum albumin >= 30 g/L
  • Effective contraception during the study period and for 5 months after the last study treatment administration (male and female patient)
  • Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
  • Ability to understand and the willingness to sign a written informed consent

Who cannot join

  • Patients having active central nervous system (CNS) metastases; patients adequately treated and neurologically returned to baseline (except for residual signs of symptoms related to the CNS treated) for at least 2 weeks prior to enrolment are allowed; in addition, patients must be either off corticosteroids or on a stable or decreasing dose of < 10 mg daily prednisone or equivalent
  • Prior exposure to cancer immunotherapy including any immune checkpoint inhibitor and/or cancer vaccines
  • Prior history of other malignancy except:
  • Basal cell carcinoma of skin
  • Cervical intra-epithelial neoplasia
  • Other cancer curatively treated with no evidence of disease for at least 2 years
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  • Patients under chronic treatment with systemic corticosteroids or other immunosuppressive drugs (e.g. cyclosporine) for a period of at least 4 weeks and whose treatment was not stopped 1 week prior to start of the study treatment (day 1 [D1] of cycle 1)
  • Positive serology for human immunodeficiency virus (HIV) or hepatitis C virus (HCV); presence in the serum of the antigen hemoglobin (HBs)
  • Patient with any underlying medical condition that the treating physician considers might be aggravated by treatment or which is not controlled (e.g. elevated troponin or creatinine, uncontrolled diabetes)
  • Patients with major surgery or radiotherapy within 4 weeks prior to the start of the study treatment (i.e. D1 of cycle 1); however, prior surgery or radiation therapy aimed at local palliation or attempted local disease control (except in case of thoracic radiotherapy) is permitted but has to be completed one week before treatment start
  • Pregnant or nursing (lactating) women, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 10 mIU/mL); pregnancy is ruled out by a beta hCG test completed if necessary with an ultrasound
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are:
  • Women whose sexual orientation precludes intercourse with a male partner
  • Women whose partners have been sterilized by vasectomy or other means
  • Using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices [IUDs]; periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable)
  • Patient with an organ allograft
  • Known allergy to eggs, gentamicin, or platinum containing compounds
  • Hypersensitivity to the active substance or to any of the excipients
  • Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment (i.e. D1 of cycle 1)
  • Patient unable or unwilling to comply with the protocol requirements
  • Subject has active, known or suspected autoimmune disease, including systemic lupus erythematodes, Hashimoto thyroiditis, scleroderma, polyarteritis nodosa, or autoimmune hepatitis
  • Subject has any peripheral neuropathy >= National Cancer Institute (NCI) CTCAE grade 2 at enrollment
  • Subject has a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies; any lung disease that may interfere with the detection or management of suspected drug-related pulmonary toxicity
  • History of any of the following cardiovascular conditions within 12 months of enrollment: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery by-pass graft surgery, symptomatic peripheral vascular disease, class III or IV congestive heart failure, as defined by the New York Heart Association
  • Left ventricular ejection fraction (LVEF) less than the lower limit of normal (LLN) as assessed by echocardiography

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • University of California San Diego

    San Diego, California, 92103

  • UCSF Medical Center-Mount Zion

    San Francisco, California, 94115

Other trials in United States

About this study

Official title: Phase II Trial of TG4010 Plus Nivolumab in Previously Treated Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC)

This phase II trial studies how well TG4010 and nivolumab work in previously treated patients with non-small cell lung cancer. Vaccines that are made from a gene-modified virus, such as TG4010, may help the body build an effective immune response to kill tumor cells. Monoclonal antibodies, such as nivolumab, interfere with the ability of tumor cells to grow and spread. Giving TG4010 and nivolumab together may work better in previously treated patients with non-small cell lung cancer.

Read the detailed description

PRIMARY OBJECTIVES:

To evaluate the efficacy of nivolumab plus TG4010 (modified vaccinia virus Ankara [MVA]-human mucin 1 [MUC1]-interleukin-2 [IL2] vaccine) in previously treated patients with stage IV non squamous non-small cell lung cancer (NSCLC) with respect to objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

SECONDARY OBJECTIVES:

Define the safety and toxicity profile of nivolumab plus TG4010 by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.

Determine progression-free survival by RECIST 1.1.

Determine overall survival.

Determine the duration of response and the occurrence of responses over time.

Determine the rate and duration of stable disease.

Determine the disease control rate.

Being tested
TG4010, Nivolumab
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.

  • TG4010Biological

    Also called Modified Vaccinia Ankara Encoding Human MUC-1 Antigen and Interleukin-2 Suspension, MVA-MUC1-IL2, MVA-MUC1-IL2 Vaccine

    Given SC

  • NivolumabBiological

    Also called BMS-936558, MDX-1106, NIVO, ONO-4538

    Given IV

Study groups in NCT02823990
Study groupRoleWhat they receive
Treatment TG4010 + nivolumabExperimentalPatients receive TG4010 SC once per week for courses 1-3 and every 2 weeks for courses thereafter and nivolumab IV over 30 minutes every 2 weeks. Courses repeat every 14 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Receives: Biological: TG4010; Biological: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR Defined as the Proportion of Patients Whose Best Overall Response (BOR) is Either Complete Response (CR) or Partial Response (PR) According to RECIST 1.1

    Number of patients with a best overall response of CR or PR, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: Up to 2 years

Secondary outcomes (6)

  1. Disease Control Rate (DCR) Defined as the Proportion of Patients Whose Best Overal Response is Either CR, PR or SD, Assessed by RECIST 1.1

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI. Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since the treatment started. Disease control rate (DCR) defined as the proportion of patients whose best overall response (BOR) is either CR, PR or SD,

    Measured: Up to 4 years

  2. Duration of Response (DOR) Defined as Patients Whose Best Overall Response is CR or PR (Confirmed Response)

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI; Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Duration of response (DOR) defined as patients whose best overall response is CR or PR (confirmed response)

    Measured: Time from the first documented response (CR or PR) until the event defined as first documented disease progression, assessed for up to 4 years

  3. Number of Participants With Adverse Events Reported Per CTCAE v4.0

    Measured: From the first dose to 100 days after last treatment, approximately up to 2 years.

  4. Overall Survival (OS)

    Measured: Time from enrollment until death from any cause, assessed for up to 4 years

  5. Progression Free Survival (PFS) Defined by RECIST 1.1

    Progression free survival (PFS) defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: Time from enrollment to the date of first documented radiographic tumor progression or death due to any cause, whichever occurs first, assessed for up to 4 years

  6. Stable Disease (SD) Rate Defined as the Proportion of Patients Whose Best Overall Response (BOR) is SD, Assessed by RECIST 1.1

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI; Stable disease (SD) rate defined as the proportion of patients whose best overall response (BOR) is stable disease (SD),

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2016 (estimated)
  2. Study start14 Dec 2016
  3. Primary completion24 Feb 2021
  4. Study completion24 Feb 2021

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02823990
Sponsor's protocol ID
885316
Other IDs
UCDCC#263, UCDCC#263, P30CA093373, NCI-2016-00960
Status last verified
Oct 2025
First submitted
1 Jul 2016
Last updated
10 Nov 2025
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TG4010 and Nivolumab in people with Recurrent Non-Small Cell Lung Carcinoma and Stage I Non-Small Cell Lung Cancer, run by Megan Daly, MD at 4 sites in United States.

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 18 inclusion and 25 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: finished, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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 phase mean?

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 10 Nov 2025). 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?

ORR Defined as the Proportion of Patients Whose Best Overall Response (BOR) is Either Complete Response (CR) or Partial Response (PR) According to RECIST 1.1 (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02823990.

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 10 Nov 2025.

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