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

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ClinicalTrials.gov Identifier: NCT03644823
Recruitment Status : Terminated (slow recruiting)
First Posted : August 23, 2018
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
Åslaug Helland, Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE February 6, 2018
First Posted Date  ICMJE August 23, 2018
Last Update Posted Date March 30, 2021
Actual Study Start Date  ICMJE August 15, 2018
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2018)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combinatory ImmunoTherapy-1 (Com-IT-1) Irradiation and PD-1 Blockade in Locally Advanced / Advanced NSCLC
Official Title  ICMJE Combinatory ImmunoTherapy-1 (Com-IT-1) Irradiation and PD-1 Blockade in Locally Advanced / Advanced NSCLC
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.
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 ClinicalTrials.gov. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Atezolizumab
    PDL1- inhibitor
    Other Name: Tecentriq
  • Radiation: Radiotherapy
    6 Gy x 3
Study Arms  ICMJE Experimental: PDL1-inhibitor and radiotherapy
PDL1-inhibitor (Atezolizumab) and Radiotherapy (6 Gy x 3)
Interventions:
  • Drug: Atezolizumab
  • Radiation: Radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 25, 2021)
21
Original Estimated Enrollment  ICMJE
 (submitted: August 21, 2018)
30
Actual Study Completion Date  ICMJE December 31, 2020
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03644823
Other Study ID Numbers  ICMJE COM-IT-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Åslaug Helland, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Åslaug Helland Radium Hospital
PRS Account Oslo University Hospital
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP