Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03023423 | A Study of Daratumumab in Combination With Atezolizumab Compared With Atezolizumab Alone in Participants With Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer | PHASE1 | COMPLETED | 100 | — | — | Dec 23, 2016 | Sep 26, 2019 | Nov 20, 2019 | 47 | United States, France +3 |
ORR was defined as the percentage of participants with partial response (PR) or complete response (CR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Criteria for CR: Disappearance of all target lesions; all lymph nodes must be of non-pathological in size (less than \[\<\]10 millimeter \[mm\] short axis; normalization of tumor marker level. Criteria for PR: greater than or equal to (\>=)30 percent (%) decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Overall Response (OR) = CR + PR. The outcome measure (OM) was planned to be reported for participants based on their initial assignment to Randomized Phase: Atezolizumab'.
| Arm | Type | Description |
|---|---|---|
| Treatment Arm A: Atezolizumab | EXPERIMENTAL | Participants in Treatment Arm A will receive Atezolizumab 1,200 milligram (mg) intravenously (IV) on Day 1 of every 21-day cycle. Participants with confirmed disease progression based on RECIST 1.1 may cross over to Arm B and receive daratumumab and atezolizumab, provided crossover eligibility criteria are met. |
| Treatment Arm B: Atezolizumab and Daratumumab | EXPERIMENTAL | Participants will receive daratumumab 16 milligram per kilogram \[mg/kg\] (Safety Run-in and Treatment Arm B) Intravenously (IV) weekly for 3 cycles (Day 1, 8 and 15), and Day 1 of every 21-day cycle thereafter. Atezolizumab will be administered at 1200 mg IV on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter. Participants will continue to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria are met. |
| Name | Type | Description |
|---|---|---|
| Atezolizumab | DRUG | Participants will receive atezolizumab 1200 mg intravenously. |
| Daratumumab | DRUG | Participants will receive daratumumab 16 mg/kg intravenously. |
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) (Stage IIIb or greater) * Measurable disease, as defined by Response Evaluation Criteria in Solid T...