NL-OMON44296
Completed
Not Applicable
Phase 1b study of safety and tolerability in patients treated with stereotactic radiotherapy combined with durvalumab and tremelimumab in stage 4 NSCLC - SBRT + durvalumab + Tremelimumab in NSCLC
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non-small cell lung cancer (NSCLC)
- Sponsor
- niversitair Medisch Centrum Groningen
- Enrollment
- 25
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Written informed consent;
- •\- Histologically confirmed stage IIIB (without curative treatment options) and stage IV NSCLC. Tumor mutation status must be known, analyzed by next generation sequencing for specific mutations;
- •\- A tumour tissue sample (\< 6 month old);
- •\- Any line of previous chemotherapy (but at least 1 line), with washout period of at least 4 weeks;
- •\- At least one unidimensionally measurable lesion according to RECIST1\.1 criteria;
- •\- Age \* 18 years;
- •\- ECOG / WHO performance status of 0 or 1;
- •\- Life expectancy of \*12 weeks;
- •\- Body weight \> 30 kg;
- •\- Adequate normal organ and bone marrow function:
Exclusion Criteria
- •\- Involvement in the planning and/or conduct of the study
- •\- Participation in another clinical study with an investigational product during the last 3 months.
- •\- Concurrent enrolment in another clinical study, unless it is an observational (non\-interventional) clinical study or during the follow\-up period of an interventional study.
- •\- Receipt of the last dose of anti\-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumour embolization, monoclonal antibodies) 1 month prior to the first dose of study drug (wash out period).
- •\- Primary tumor smaller than 3 cm.
- •\- Any unresolved toxicity NCI CTCAE Grade \* 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
- •\- Patients with Grade \* 2 neuropathy will be evaluated on a case\-by\-case basis after consultation with the Study Physician.
- •\- Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the Study Physician.
- •\- Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non\-cancer\-related conditions (eg, hormone replacement therapy) is acceptable.
- •\- Any history of radiotherapy treatment to the chest.
Outcomes
Primary Outcomes
Not specified
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