Phase 2
Completed N=99
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
Source: ClinicalTrials.gov NCT03023423 ↗Enrolled (actual)
99
Serious AEs
41.8%
Results posted
Jul 2019
Primary outcomePrimary: Percentage of Participants With Overall Response Rate (ORR) — 13.0; 4.3 Percentage of participants
Summary
The purpose of the study is to compare the overall response rate (ORR) in non-small cell lung cancer (NSCLC) participants treated with daratumumab in combination with atezolizumab versus atezolizumab alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Overall Response Rate (ORR) |
13.0; 4.3 | — |
| SECONDARY Number of Participants With Adverse Events |
7; 42; 44; 8 | — |
| SECONDARY Duration of Response (DoR) |
5.8; 2.9 | — |
| SECONDARY Clinical Benefit Rate |
43.5; 52.2 | — |
| SECONDARY Progression-Free Survival (PFS) |
1.48; 1.68 | — |
| SECONDARY Overall Survival (OS) |
NA; 7.13 | — |
| SECONDARY Daratumumab Serum Concentration |
0.00; 0.00; 417.13; 296.12; 393.95; 278.42 | — |
| SECONDARY Atezolizumab Serum Concentration |
0.00; 0.00; 396.51; 440.00; 0.00; 0.00 | — |
| SECONDARY Number of Participants With Anti-Daratumumab Antibodies |
0; 0 | — |
| SECONDARY Number of Participants With Anti-Atezolizumab Antibodies |
0; 6; 5 | — |
Eligibility Criteria
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 Tumors (RECIST) 1.1
- Tumor cell programmed death-ligand 1 (PD-L1) score of tumor cells (TC)1-3 and immune cell PD-L1 score of tumor-infiltrating immune cells (IC)0-3 as determined by an immunohistochemistry (IHC) assay performed by the central laboratory on tissue obtained after the last line of therapy
- A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta- hCG]) at Screening within 14 days prior to study drug administration
Inclusion Criteria for Crossover:
- Participants must have been randomized to Arm A of the study and had radiographic disease progression according to RECIST 1.1
- Participants must have a mandatory biopsy at the time of disease progression according to RECIST 1.1 prior to crossing over. If not clinically feasible, discussion with Sponsor is required
- The first dose of atezolizumab in the crossover arm should be within 42 days of last dose but no less than 21 days from the last dose prior to crossing over
Exclusion Criteria
- Received any of the following prescribed medications or therapies in the past:
- Anti-cluster of differentiation(CD)38 therapy, including daratumumab
- CD137 agonists, immune checkpoint inhibitors including but not limited to CTLA-4, anti-PD-1, and anti-PD-L1 therapies
- Known to be seropositive for human immunodeficiency virus (HIV)
- Prior allogeneic bone marrow transplantation or solid organ transplant
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Active hepatitis B, defined by a positive test for hepatitis B surface antigen [HBsAg] or prior history of hepatitis B, defined by presence of antibodies to hepatitis B core antigen [anti-HBc], regardless of hepatitis B surface antibody [anti-HBs] status; active hepatitis C or prior history of hepatitis C (anti-HCV positive), except in the setting of a sustained virologic response (SVR), defined as aviremia 12 weeks after completion of antiviral therapy. If hepatitis C virus (HCV) antibodies are detected, an HCV RNA test for viral load by polymerase chain reaction (PCR) should be performed at least 12 weeks after completion of antiviral therapy to rule out active infection
Exclusion Criteria for Crossover:
- Received any subsequent anti-cancer therapies from the time between the last dose of atezolizumab prior to the first administration of study drug after crossing over
- Whole brain radiation within 28 days or other radiotherapy within 14 days prior to first administration of study drug after crossing over
Data sourced from ClinicalTrials.gov (NCT03023423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.