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

• Status: Terminated
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Treatments: Atezolizumab

Criteria

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