NL-OMON24908
Recruiting
Not Applicable
Ipilimumab plus nivolumab and chemoradiotherapy followed by surgery in patients with resectable and borderline resectable T3-4N0-1 non-small cell lung cancer
VU University Medical Center0 sites29 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- (borderline) resectable non-small cell lung cancer (NSCLC), T3-4N0-1
- Sponsor
- VU University Medical Center
- Enrollment
- 29
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Histologically confirmed NSCLC
- •2\.T3\-4N0\-1 tumors based on size or invasion into the thoracic wall, mediastinum, vertebra or diaphragm
- •3\.Patients who are irresectable upfront, but expected to be resectable after chemoradiotherapy induction, as per multidisciplinary tumor board evaluation
- •4\.Willing and able to provide written informed consent for the trial.
- •5\.Aged above 18 years on day of signing informed consent.
- •6\.Have measurable disease based on RECIST 1\.1\.\*
- •7\.Have a performance status of 0\-1 on the ECOG Performance Scale.
- •8\.Demonstrate adequate organ function.
Exclusion Criteria
- •1\.Known oncogenic drivers such as activating EGFR or BRAF mutations or ALK or ROS1 gene rearrangements
- •2\.Prior surgery and/or radiotherapy on the ipsilateral thorax
- •3\.Patients deemed inoperable
- •4\.Active autoimmune disease.
- •5\.Chronic systemic steroid therapy
- •6\.Additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
- •7\.Evidence of interstitial lung disease or active, non\-infectious pneumonitis.
- •8\.Active infection requiring systemic therapy.
- •9\.A history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- •10\.Active Hepatitis B or C.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Does adding double immunotherapy to the combination of chemotherapy and radiotherapy result in a better anti-tumor efficacy?locally advanced non-small cell lung cancerMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10029519Term: Non-small cell lung cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2019-003454-83-NLAmsterdam UMC, VU University Medical Center29
Completed
Phase 2
Ipilimumab plus Nivolumab and ChemoRadiotherapy followed by Surgery in patients with resectable and borderline resectable T3-4N0-1 NSCLClung cancerlung carcinoma1003866610029107NL-OMON48462Vrije Universiteit Medisch Centrum29
Completed
Phase 2
Nivolumab + Chemoradiation in Stage II-IVB Nasopharyngeal Carcinoma (NPC)Nasopharyngeal CarcinomaNCT03267498Sue Yom40
Withdrawn
Phase 2
Chemo-radio-immunotherapy With Nivolumab and Ipilimumab Treatment in Locally Advanced Cervical Cancer PatientsCervical Cancer ≥ FIGO IIB and or Lymph Node MetastasesNCT05504642Universitätsklinikum Köln
Active, not recruiting
Phase 1
Immunotherapy with initial radiation and influenza vaccine for patients with pancreatic cancer.EUCTR2021-003931-27-DKDepartment of Oncology, Herlev & Gentofte Hospital30