Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Atezolizumab · 1 trial · 1 indication
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...
Atezolizumab is being studied for use in previously treated advanced or metastatic non-small cell lung cancer. It is an investigational therapy in Phase 1 clinical development, evaluated in combination with daratumumab compared with atezolizumab alone in this patient population.
Atezolizumab is a monoclonal antibody, classified as a -mab (antibody) modality. It is being investigated for its role in oncology, specifically in non-small cell lung cancer, where it is studied in combination with daratumumab.
Atezolizumab is being developed by Johnson & Johnson, a company traded under the ticker JNJ. The drug is currently in Phase 1 clinical development for the treatment of non-small cell lung cancer.
Atezolizumab is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied in a completed Phase 1 trial for previously treated advanced or metastatic non-small cell lung cancer.
Atezolizumab has one completed clinical trial, NCT03023423, titled '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.' The trial enrolled 100 participants across the United States, France, Hungary, Poland, and Spain.
No, Atezolizumab is not the same as daratumumab. They are distinct drugs studied in combination in clinical trial NCT03023423, which compares daratumumab plus atezolizumab versus atezolizumab alone in non-small cell lung cancer.