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Combinatory ImmunoTherapy-1 (Com-IT-1) Irradiation and PD-1 Blockade in Locally Advanced / Advanced NSCLC (COM-IT-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03644823
Recruitment Status : Terminated (slow recruiting)
First Posted : August 23, 2018
Last Update Posted : March 30, 2021
Information provided by (Responsible Party):
Åslaug Helland, Oslo University Hospital

Brief Summary:
In this study, the investigators will investigate toxicity in patients treated with a Programmed cell death protein 1 (PD-1) inhibitor and radiotherapy. Patients with advanced Non-Small Cell Lung Cancer (NSCLC) can be included when treatment with a PD-1 inhibitor is indicated according to national guidelines. Included patients will receive stereotactic radiotherapy to one or two tumour lesion(s) in addition to the PD-1 inhibitor, and toxicity is the primary endpoint.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Atezolizumab Radiation: Radiotherapy Phase 2

Detailed Description:

This phase II study will investigate NSCLC patients (stage III-IV, palliative treated) where treatment with a PD1-inhibitor is indicated according to national guidelines. Patients will be treated with a check-point inhibitor combined with radiotherapy (6 Gy x 3) towards lesions (1-2). Atezolizumab is available and reimbursed in the public health system. The radiotherapy dosing is significantly lower than standard stereotactic radiotherapy, and is in accordance with other studies reported in Such a fractionation will putatively induce immunogenic cell death, while being a safe treatment, not likely to induce significant side effects.

Whereas the primary endpoint in our clinical study will be toxicity, the secondary endpoints include response rates, overall survival, safety and tolerability, quality of life, progression-free survival and duration of response. In addition, exploratory endpoints will include immunological response, tumor evolution and dynamics in the tumor microenvironment during treatment, imaging, and biomarkers of clinical response.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combinatory ImmunoTherapy-1 (Com-IT-1) Irradiation and PD-1 Blockade in Locally Advanced / Advanced NSCLC
Actual Study Start Date : August 15, 2018
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: PDL1-inhibitor and radiotherapy
PDL1-inhibitor (Atezolizumab) and Radiotherapy (6 Gy x 3)
Drug: Atezolizumab
PDL1- inhibitor
Other Name: Tecentriq

Radiation: Radiotherapy
6 Gy x 3

Primary Outcome Measures :
  1. Incidence, nature, and severity of adverse events graded according to NCI CTCAE v4.0 [ Time Frame: 24 months ]
    Adverse events will be graded according to the NCI-CTCAE version 4.0, and registered

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: 24 months ]
    Survival data and responses will be evaluated from tumor assessments per RECIST v1.1, or death from any cause

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

5.1.1 Subject Inclusion Criteria

  • Age >18 years
  • Advanced NSCLC
  • Adequate newly obtained core or excisional biopsy of a recurrent tumor lesion
  • Adequate is defined as a biopsy with at least 5 sections tumour tissue available.
  • Measurable disease according to RECIST criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy > 3 months
  • A tumour lesion suitable for radiotherapy treatment
  • Adequate organ function based on clinical examination and lab values (Hb >9.0, Leucocytes > 2.0, Trc > 100, AST/ALT <3 ULN)
  • Women must not be pregnant or breastfeeding
  • WOCBP should use an adequate highly effective method to avoid pregnancy for 23 weeks
  • For the purpose of this document, a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.

    • Highly effective contraception methods includes methods that can achieve a failure rate of less than 1% per year when used consistently and correctly. Such methods include:
    • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
    • progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
    • intrauterine device (IUD)
    • intrauterine hormone-releasing system ( IUS)
    • bilateral tubal occlusion
    • vasectomised partner
  • sexual abstinence ___________________________________
  • Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for a period of 90 days (duration of sperm turnover) plus the time required for the investigational drug to undergo five half-lives
  • Previously untreated or treated NSCLC pts, where treatment with PD1-inhibitor in indicated according to national guidelines.

Exclusion Criteria:

5.1.2 Subject Exclusion Criteria

  • Disease suitable for curative salvage surgery
  • Treatment with any investigational medicinal product (IMP) that may interfere with the study treatment, within 2 weeks prior to first administration of study drug.
  • Significant cardiac, pulmonary or other medical illness that would limit activity or survival
  • Pregnancy or lactation.
  • Patients with EGFR-mutation or ALK-translocation not treated with tyrosine kinase inhibitor previously
  • Known hypersensitivity to any of the components of the investigational product
  • Patients who test positive for hepatitis B, C or HIV.
  • Known active brain metastases. Patients with stable / treated brain metastases can be included.
  • Diagnosis of immunodeficiency or medical condition requiring high doses (>30 mg prednisolone daily) of systemic steroids or other forms of immunosuppressive therapy
  • Any reason why, in the opinion of the investigator, the patient should not participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03644823

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Oslo University Hospital
Oslo, Norway, 0379
Sponsors and Collaborators
Oslo University Hospital
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Principal Investigator: Åslaug Helland Radium Hospital
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Responsible Party: Åslaug Helland, Professor, Oslo University Hospital Identifier: NCT03644823    
Other Study ID Numbers: COM-IT-1
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Åslaug Helland, Oslo University Hospital:
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents