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

NCT03644823 | Terminated Phase 2

• 1 other identifier: COM-IT-1
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

radiotherapy; PD1-inhibitor

Outcome Measures

Primary Outcomes (1)

• Incidence, nature, and severity of adverse events graded according to NCI CTCAE v4.0

  Adverse events will be graded according to the NCI-CTCAE version 4.0, and registered

  24 months

Secondary Outcomes (1)

• Progression free survival

  24 months

Study Arms (1)

PDL1-inhibitor and radiotherapy

EXPERIMENTAL

PDL1-inhibitor (Atezolizumab) and Radiotherapy (6 Gy x 3)

Drug: Atezolizumab; Radiation: Radiotherapy

Interventions

Atezolizumab DRUG

PDL1- inhibitor

Also known as: Tecentriq

PDL1-inhibitor and radiotherapy

Radiotherapy RADIATION

6 Gy x 3

PDL1-inhibitor and radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, 0379, Norway

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

atezolizumab; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Åslaug Helland

  Radium Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: August 23, 2018
• Study Start: August 15, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)