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Non-small Cell Lung CancerPhase 1NCT02460367

Immunotherapy Combination Study in Advanced Previously Treated Non-Small Cell Lung Cancer

A Phase 1 study testing Docetaxel, Tergenpumatucel-L and Indoximod in people with Non-small Cell Lung Cancer and Progression of Non-small Cell Lung Cancer, run by NewLink Genetics Corporation at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a Phase 1/2 trial using indoximod, an inhibitor of the immune "checkpoint" pathway indoleamine 2,3-dioxygenase (IDO), in combination with Tergenpumatucel-L immunotherapy and Docetaxel to treat subjects with advanced Non-Small Cell Lung Cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Docetaxel, Tergenpumatucel-L and Indoximod
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
2 sitesUnited States
Study dates
Jan 2016to 13 Jan 2021
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Histological/cytological diagnosis of non-small cell lung cancer (NSCLC). Squamous cell (epidermoid), adenocarcinoma, bronchoalveolar carcinoma and large cell anaplastic lung carcinoma histologies are eligible. Mixed histologies of NSCLC (i.e., adenosquamous) are eligible. Mixed NSCLC/small cell lung carcinoma (SCLC), and variant large and small cell lung cancer are NOT eligible for this study.
  • Measurable disease as defined by RECIST 1.1 Criteria.
  • At least one but no more than three prior lines of therapy in the advanced stage are allowed. One prior line of therapy must be platinum doublet chemotherapy.
  • At least 18 years of age.
  • ECOG performance status ≤ 1
  • Normal bone marrow and organ function as defined below:
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  • Marrow: Hemoglobin ≥10.0 gm/dL, absolute granulocyte count (AGC) ≥1,000/mm3 platelets ≥100,000/mm3, absolute lymphocyte count ≥1000/mm3.
  • Hepatic: Serum/plasma total bilirubin ≤1.5 x upper limit of normal (ULN) with the exception of <2.9 mg/dL for patients with Gilbert's disease, ALT (SGPT) and AST (SGOT) ≤2.5 x ULN.
  • Renal: Serum/plasma creatinine (sCr) ≤1.5 x upper limit of normal, or creatinine clearance (Ccr) ≥50 mL/min.
  • Serum/plasma albumin > 3.0 gm/dL
  • Sexually active women of child-bearing potential must agree to use two forms of contraception prior to study entry and for the duration of study participation. A pregnancy test is required prior to study enrollment and monthly while on treatment with indoximod for all women of child- bearing potential. Also men should be discouraged from fathering children while on treatment.
  • Ability to understand and willingness to sign an IRB approved written informed consent document.

Who cannot join

  • More than three lines of prior therapy.
  • Previous use of indoximod or tergenpumatucel-L immunotherapy.
  • A history of other malignancy, unless treated with curative intent, and no evidence of disease for at least 2 years.
  • Current therapy with any other investigational agents.
  • Untreated CNS disease, metastases or carcinomatous meningitis. Patients with CNS metastases must be at least 2 weeks status post prior therapy to the brain and be off all steroids without progressing CNS disease or symptoms.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to indoximod, docetaxel, or other agents used in the study.
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  • Current use of immunosuppressive drugs or use of corticosteroids, except for inhaler, topical corticosteroids, or dexamethasone in the premedication for docetaxel.
  • Other malignancy within three years, unless the probability of recurrence of the prior malignancy is <5%. Patient's curatively treated for squamous cell carcinoma and basal cell carcinoma of the skin and carcinoma in situ of the uterine cervix (CIN) or patients with a history of malignant tumor in the past that have been disease free for at least five years are also eligible for this study.
  • History of organ transplant.
  • Any of the following within 6 months prior to study drug administration:
  • Myocardial infarction
  • Severe/unstable angina
  • Coronary/peripheral artery bypass graft
  • Symptomatic congestive heart failure
  • Cerebrovascular accident or transient ischemic attack
  • Pulmonary embolism
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled ongoing cardiac dysrhythmias of ≥ grade 2, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
  • Known HIV-positivity on combination antiretroviral therapy because of the unknown potential for pharmacokinetic interactions with indoximod, or docetaxel. In addition, these patients are at increased risk of lethal infections when treated with marrow suppressive therapy.
  • Active autoimmune disease requiring systemic therapy. Patients with a history of autoimmune disease must be counselled regarding the unknown potential of exacerbating or reactivating previous or dormant autoimmunity during the consent process.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • Washington University in St. Louis

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase 1b/2 Study of Tergenpumatucel-L (HyperAcute Lung) Immunotherapy in Combination With the IDO Pathway Inhibitor Indoximod and Docetaxel in Patients With Advanced Previously Treated Non-Small Cell Lung Cancer (NSCLS)

This is a Phase 1/2 trial using indoximod, an inhibitor of the immune "checkpoint" pathway indoleamine 2,3-dioxygenase (IDO), in combination with Tergenpumatucel-L immunotherapy and Docetaxel to treat subjects with advanced Non-Small Cell Lung Cancer (NSCLC). From a practical standpoint, a successful tumor immunotherapy will likely require a combination treatment with additional therapeutic interventions that both activate an immune response and remove redundant mechanisms of tolerance maintenance. This clinical trial utilizes the combination of the chemotherapeutic agent, docetaxel, plus two investigational methods of cancer immunotherapy: the first, tergenpumatucel-L, is intended to educate the human immune system to recognize the abnormal components found in lung cancer cells, resulting in an immune response intended to destroy or block the growth of the cancer; and the second, the IDO inhibitor Indoximod, will overcome tumor-induced immune suppression.

The goal of this study is to assess the progression-free survival (PFS) and overall survival (OS) rates in this patient population. This study will provide a foundation for future trials testing indoximod combined with tergenpumatucel-L.

Being tested
Docetaxel, Tergenpumatucel-L, Indoximod
Keywords
Non-small Cell Lung Cancer, Vaccine Therapy, Immunotherapy, Second line therapy, Progressive, Relapsed, IDO, IDO Inhibitor
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    Also called Taxotere®

  • Tergenpumatucel-LBiological

    Also called HyperAcute®-Lung Immunotherapy

  • IndoximodDrug

    Also called D-1MT, 1-methyl-D-tryptophan

Study groups in NCT02460367
Study groupRoleWhat they receive
Phase 1: Dose EscalationExperimentalUp to 18 participants will be enrolled and treated at escalating doses of Indoximod with a fixed dose of tergenpumatucel-L and docetaxel. Treatment may continue until definitive disease progression or significant toxicology.
Receives: Drug: Docetaxel; Biological: Tergenpumatucel-L; Drug: Indoximod

What is being measured

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

  1. Regimen Limiting Toxicity

    Phase 1 component: To identify the regimen limiting toxicity (RLT) for the combination of tergenpumatucel-L and indoximod.

    Measured: Approximately 6 weeks

  2. Progression Free Survival (PFS)

    Measured: Approximately 18 months

Secondary outcomes (4)

  1. Frequency and grade of adverse events of tergenpumatuucel-L, indoximod and docetaxel

    Measured: Approximately 18 months

  2. Objective Response Rate

    To assess preliminary evidence of efficacy of tergenpumatuucel-L, indoximod and docetaxel using RECIST 1.1 measurement criteria.

    Measured: Approximately 18 months

  3. Overall Survival

    Measured: Approximately 30 months

  4. Response rate to subsequent therapy

    Assess evidence of delayed response of tergenpumatuucel-L, indoximod and docetaxel using RECIST 1.1 measurement criteria.

    Measured: up to 36 months

Timeline

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

  1. First posted2 Jun 2015 (estimated)
  2. Study startJan 2016
  3. Primary completion17 Jul 2017
  4. Study completion13 Jan 2021

Why it stopped: Lack of enrollment and changing landscape of standard of care.

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02460367
Sponsor's protocol ID
NLG0401
Other IDs
1504-1393
Status last verified
Apr 2022
First submitted
21 May 2015
Last updated
6 Apr 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Docetaxel, Tergenpumatucel-L and Indoximod in people with Non-small Cell Lung Cancer and Progression of Non-small Cell Lung Cancer, run by NewLink Genetics Corporation at 2 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 12 inclusion and 20 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 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Lack of enrollment and changing landscape of standard of care.). Results are not available in the source record.

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?

Regimen Limiting Toxicity (time frame: Approximately 6 weeks). The study lists 2 primary outcomes in all. 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 NCT02460367.

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 6 Apr 2022.

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Clinical Trial NCT02460367 | AzTrials