Study study type PathologyT1T0Patientssample sizesROB Results

mNSCLC - L1 - all population metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) mNSCLC - L1 - all population

versus placebo plus SoC
sintillimab plus SoC
ORIENT-11, 2020
  NCT03607539
RCTmNSCLC - L1 - all populationSintilimab plus pemetrexed plus platineplacebo plus pemetrexed plus platinepatients with confirmed stage IIIB to IV nonsquamous NSCLC who had no previous systemic treatment for advanced and metastatic disease.266 / 131low
conclusif
  • suggested 39 % decrease in deaths (OS)
  • demonstrated 52 % decrease in progression or deaths (PFS) (PE)
versus Standard of Care (SoC)
cemiplimab
EMPOWER lung1 (all population), 2021
  NCT03088540
RCTmNSCLC - L1 - all populationcemiplimabICCpatients with confirmed stage IIIB or IIICor stage IV squamous or non-squamous non-small-celllung cancer356 / 354some concern
conclusif
  • demonstrated 32 % decrease in deaths (OS) (PE)
  • demonstrated 41 % decrease in progression or deaths (PFS) (PE)
  • demonstrated 1.2-fold increase in objective responses (ORR) (PE)
durvalumab alone
MYSTIC (D ; all population), 2020
  NCT02453282
RCTmNSCLC - L1 - all populationdurvalumabplatinum-based doublet chemotherapyfirst-line treatment of patients locally advanced or metastatic NSCLC with PDL1 TC >=25%374 / 372some concern
inconclusive
    no statistically significant result