Recruiting PHASE1 Metastatic Lung Non-Small Cell Carcinoma

New treatment option for Metastatic Lung Non-Small Cell Carcinoma

Official title Vismodegib and Atezolizumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer

ClinicalTrials.gov ID: NCT06616623

What this study is testing

What is Atezolizumab?

Atezolizumab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for metastatic lung non-small cell carcinoma.

Also referred to as MPDL 3280A, MPDL 328OA.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing: This phase Ib trial tests the safety, side effects, and best dose of the combination of vismodegib and atezolizumab in treating patients with non-small cell lung cancer (NSCLC) that has come back after a period of improvement (recurrent) or has spread from where it first started (primary site) to other places in the body (metastatic). Vismodegib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

Age ≥ 18 years
Confirmed recurrent or metastatic non-small cell carcinoma of the lung of any histology without curative options
Measurable disease based on RECIST v1.1
Patients must have received standard of care chemotherapy and/or immunotherapy. No limits to prior lines of therapy. Prior PD-1 and/or PD-L1 directed...
Patients with adenocarcinoma and known actionable mutations with Food and Drug Administration (FDA) approved treatment options must have received all...

You likely can't join if

Active autoimmune disease requiring treatment or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis...
Patients with a history of autoimmune-related hypothyroidism who are stable on thyroid-replacement hormone are eligible for the study
Patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study
Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis...
Rash must cover ≤ 10% of body surface area
Disease is well controlled at baseline and requires only low-potency topical corticosteroids

See the full eligibility criteria

Who can join

Age ≥ 18 years
Confirmed recurrent or metastatic non-small cell carcinoma of the lung of any histology without curative options
Measurable disease based on RECIST v1.1
Patients must have received standard of care chemotherapy and/or immunotherapy. No limits to prior lines of therapy. Prior PD-1 and/or PD-L1 directed therapies are permitted
Patients with adenocarcinoma and known actionable mutations with Food and Drug Administration (FDA) approved treatment options must have received all approved and standard of care treatment options (i.e. osimertinib for...
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Absolute neutrophil count (ANC) ≥ 1,500 /mcL without granulocyte colony-stimulating factor support
Platelet count ≥ 100,000 /uL without transfusion
Hemoglobin ≥ 90 g/L (9 g/dL) patients may be transfused to meet this criterion
Measured or calculated creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 60 mL/min for subject with creatinine levels ≤ 1.5 x institutional upper limit of normal (ULN)
Serum total bilirubin ≤ 1.5 x ULN with the following exception:
Patients with known Gilbert disease: serum bilirubin ≤ 3 x ULN
Direct bilirubin ≤ ULN for people with total bilirubin levels \> 1.5 ULN
Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 x ULN with the following exceptions:
Patients with documented liver metastases: AST and ALT ≤ 5 x ULN
Both values must be in the specified range
Alkaline phosphatase (ALP) ≤ 2.5 x ULN with the following exceptions:
Patients with documented liver or bone metastases: ALP ≤ 5 x ULN
Albumin ≥ 2.5 g/dL
International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy
As long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy
As long as PT or PTT is within therapeutic range of intended use of anticoagulants
Anticipated life expectancy of ≥ 3 months
Willing to comply with study procedures
Female subject of childbearing potential will have a serum pregnancy test at screening. Urine pregnancy tests will be performed at specified subsequent visits. If a urine pregnancy test is positive, it must be confirmed...
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:
Women must remain abstinent or use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for 5 months after the final dose of atezolizumab and 24 months after the final dose of...
A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not...
Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and...
The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation...
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, for 5 months from last atezolizumab dose and 24 months after...
With a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period and, for 5 months from last atezolizumab dose and 24 months after the...
The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation...
Be willing and able to understand and sign the written informed consent document
Availability of a recent formalin-fixed, paraffin-embedded (FFPE) tumor tissue block. A recently obtained archival FFPE tumor tissue block (if an FFPE tissue block cannot be provided, 15 unstained slides (10 minimum)...
Be willing to provide tissue from an on-treatment fine needle aspiration (FNA) or core biopsy of a tumor lesion. people must consent to on-treatment biopsy prior to initiation of clinical trial, however people for whom...
Negative HIV test at screening with the following exception: patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count \> 200/uL, and have an...
Negative total hepatitis B core antibody (HBcAb) test at screening. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at screening
The HCV RNA test must be performed for patients who have a positive HCV antibody test

What rules you out

Active autoimmune disease requiring treatment or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory...
Patients with a history of autoimmune-related hypothyroidism who are stable on thyroid-replacement hormone are eligible for the study
Patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study
Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following...
Rash must cover ≤ 10% of body surface area
Disease is well controlled at baseline and requires only low-potency topical corticosteroids
No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral...
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy at doses \> 10 mg prednisone or equivalent or other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment
Cirrhosis (Child-Pugh B or worse) or cirrhosis with history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis...
Has symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis. people with asymptomatic CNS lesions will be eligible if considered appropriate by the treating physician. people with previously...
Asymptomatic patients with treated CNS lesions are eligible, provided that all of the following criteria are met:
Measurable disease, per RECIST v1.1, must be present outside the CNS
The patient has no history of intracranial hemorrhage or spinal cord hemorrhage
The patient has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection...
The patient has no ongoing requirement for corticosteroids as therapy for CNS disease
If the patient is receiving anti-convulsant therapy, the dose is considered stable
Pregnancy or breastfeeding or intention of becoming pregnant during study treatment or within 5 months for atezolizumab or within 24 months after the final dose of vismodegib.
Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is...
Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render...
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...
Known active tuberculosis (specific testing is only needed if clinically indicated)
Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment...
Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that could...
Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive...
Prior allogeneic stem cell or solid organ transplantation
Live, attenuated vaccines (e.g., FluMist®) are prohibited within 4 weeks prior to initiation of study treatment, during treatment with atezolizumab, and for 5 months after the last dose of atezolizumab
Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study...
History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation
Any patient who experience unacceptable toxicity on prior checkpoint inhibitor therapy:
≥ grade 3 adverse event (AE) related to checkpoint inhibitor
≥ grade 2 immune-related AE associated with checkpoint inhibitor
CNS, ocular or cardiac AE of any grade related to checkpoint inhibitor
NOTE: Patients with a prior endocrine AE are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic

The study team makes the final eligibility decision.

Where it's taking place

Columbus, Ohio, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.