Roche 2015

Trial name or title	A phase III, open‐label, randomized study to investigate the efficacy and safety of MPDL3280a (anti‐PD‐L1 antibody) compared with best supportive care following adjuvant cisplatin‐based chemotherapy in PD‐L1‐selected patients with completely resected stage IB‐IIIA non‐small cell lung cancer
Methods	Interventional RCT, Phrase III
Participants	Number of participants: 1127 (October 2015 to February 2026) Number randomised: Experimental group (Atezolizumab): not specified Control group (Placebo): not specified Number evaluated: Experimental group: not specifid Control group: not specified Diagnosis: patients were stage IB to IIIA NSCLC Inclusion: The eligibility criteria are as follows: ≥ 18 years of age, ECOG performance status of 0 or 1, histological or cytological diagnosis of stage IB (tumours ≥ 4 cm) to IIIA (T2‐3 N0, T1‐3 N1, T1‐3 N2) NSCLC, Patients must have had complete resection of NSCLC 6‐12 weeks (≥ 42 days and ≤ 84 days) prior to enrolment and must be adequately recovered from surgery. Complete mediastinal lymph node dissection (MLND) is required. If mediastinoscopy was not performed preoperatively, mediastinal lymph node systematic sampling will have occurred. Systematic sampling is defined as removal of at least one representative lymph node at specified levels. MLND entails resection of all lymph nodes at those same levels. For a right thoracotomy, sampling or MLND is required at levels 4 and 7 and for a left thoracotomy, levels 5, 6 (or both) and 7. If there is clear documentation in the operative report or in a separately submitted addendum by the surgeon of exploration of the required lymph node areas, the patient will be considered eligible if no lymph nodes are found in those areas. If patients have documented N2 disease in one level, not all levels need to be sampled. Eligibility to receive a cisplatin‐based chemotherapy regimen. Adequate hematologic and end‐organ function, defined by the following laboratory results obtained within 14 days prior to enrolment. Women who are not postmenopausal (≥ 12 months of non‐therapy‐induced amenorrhoea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of cisplatin‐based chemotherapy.
Interventions	Experimental group: Atezolizumab (MPDL3280A) 1200 mg will be administered intravenously (IV) every 3 weeks for 16 cycles Control group: Best supportive care (BSC)
Outcomes	Disease‐free survival, overall survival, adverse events, immunogenicity, pharmacokinetics.
Starting date	October 2015
Contact information	Correspondence for published protocol: global.rochegenentechtrials@roche.com
Notes	Patient recruiting stage