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Table 1 Inclusion and exclusion criteria for participation in the INCREASE trial

From: Ipilimumab plus nivolumab and chemoradiotherapy followed by surgery in patients with resectable and borderline resectable T3-4N0–1 non-small cell lung cancer: the INCREASE trial

Inclusion criteria Exclusion 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.a
 7. Have a performance status of 0–1 on the ECOG Performance Scale.
 8. Demonstrate adequate organ function.
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.
  1. a RECIST: Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1·1) Eur J Cancer. 2009;45:228–47
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