Pembrolizumab Alone versUs pembrolizumab-chemotherapy in first LInE NSCLC (PAULIEN)

Prior treatment

• Patients amenable for local consolidative therapies
• Use of steroids equivalent to >10 mg prednisolon per day prior to start of study or other immunosuppressive medications within 14 days prior. Inhaled or topical steroids, and adrenal replacement steroid >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
• Prior systemic therapy for the NSCLC using chemotherapy or immunotherapy with 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.

Other illness

• Uncontrolled active infections, HIV, active Hepatitis B or C
• Autoimmune diseases and interstitial lung diseases are to be excluded depending on physicians decision
• A known 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.
• Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Other

• Untreated brain metastases
• Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the trial, starting with the screening.

• Histologically confirmed NSCLC, negative for EGFR mutations and ALK fusions, no molecular testing is required in squamous NSCLC
• ECOG Performance Scale 0-2
• Be willing and able to provide written informed consent for the trial
• Be 18 years or older of age on the day of signing informed consent
• Have measurable disease based on RECIST v1.1
• Must provide tissue from a histological tumor biopsy that was not yet irradiated
• High tumor PD-L-1 expression (≥50% TPS)
• High tumor burden (metastases (M1)) and not amenable for local consolidative therapies
• Must have adequate hematologic and organ function