Clinical trial · Interventional
Combinatory ImmunoTherapy-1 (Com-IT-1) Irradiation and PD-1 Blockade in Locally Advanced / Advanced NSCLC
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow recruiting
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PDL1-inhibitor and radiotherapy
- description
- PDL1-inhibitor (Atezolizumab) and Radiotherapy (6 Gy x 3)
- interventionNames
- Drug: Atezolizumab
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Incidence, nature, and severity of adverse events graded according to NCI CTCAE v4.0
- timeFrame
- 24 months
- description
- Adverse events will be graded according to the NCI-CTCAE version 4.0, and registered
Secondary outcomes (1)
- measure
- Progression free survival
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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