(borderline) resectable non-small cell lung cancer (NSCLC), T3-4N0-1
Conditions
Interventions
Patients will be discussed in a multidisciplinary tumor board (MDT) to assess the best treatment strategy. Those recommended to undergo CRT followed by surgery, are eligible for study inclusion. CRT w
Sponsors
VU University Medical Center
Eligibility
Inclusion 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
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. 11. Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 12. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways. 13. Patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the pre-screening or screening visit through 23 weeks after the last dose of trial treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the (1) safety of adding IPI/NIVO to CRT induction, and (2) the impact on pathological tumor response. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the impact of adding IPI/NIVO to CRT on disease free and overall survival. | — |
Contacts
Public ContactChris Dickhoff
Aumc
Outcome results
None listed