Description:
This is a research study to evaluate the safety and effectiveness of tocilizumab in
combination with atezolizumab to treat non-small cell lung cancer.
Title
- Brief Title: Tocilizumab and Atezolizumab in Adults With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Refractory to 1st Line Immune Checkpoint Inhibitor-Based Therapy
- Official Title: A Phase Ib-II Trial of Tocilizumab and Atezolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Refractory to 1st Line Immune Checkpoint Inhibitor-Based Therapy
Clinical Trial IDs
- ORG STUDY ID:
UPCC 16520
- NCT ID:
NCT04691817
Conditions
- Lung Cancer, Nonsmall Cell
Interventions
| Drug | Synonyms | Arms |
|---|
| Atezolizumab | Tecentriq | Atezolizumab and Tocilizumab |
| Tocilizumab | Actemra, RoActemra, RO4877533 | Atezolizumab and Tocilizumab |
Purpose
This is a research study to evaluate the safety and effectiveness of tocilizumab in
combination with atezolizumab to treat non-small cell lung cancer.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Atezolizumab and Tocilizumab | Experimental | Participants receive Atezolizumab 1200mg IV and Tocilizumab 6mg/kg IV (or Tocilizumab 4mg/kg IV) every 21 days | |
Eligibility Criteria
Inclusion Criteria:
- Advanced non-squamous NSCLC (Stage IV or recurrent after initial curative intent
therapy) in adults age 18 or older
- Prior exposure to at least 1 line of therapy
- Exposure to a including checkpoint inhibitor in line of therapy immediately prior to
enrollment on trial
- ECOG PS 0-2
Exclusion Criteria:
- Presence of a driver mutation that is susceptible to targeted therapy
- No greater than CTCAE v5 grade 3 toxicity attributed to prior immunotherapy
- Other active invasive malignancy requiring ongoing therapy
- Evidence of progressing or untreated brain metastases
- Evidence or history of leptomeningeal disease
- Uncontrolled tumor related pain
- History of an autoimmune disease or IPF
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Overall response rate (ORR) |
| Time Frame: | From first dose of protocol treatment until radiologic disease assessment at 12 weeks. |
| Safety Issue: | |
| Description: | Assess the proportion of patients with a radiologic response by RECIST 1.1 at 12 weeks. |
Secondary Outcome Measures
| Measure: | Overall survival (OS) |
| Time Frame: | From first dose of protocol treatment until death due to any cause or last patient contact alive until 3 months after study closure. |
| Safety Issue: | |
| Description: | Estimate the time from first dose of protocol treatment until death due to any cause or last patient contact alive until 3 months after study closure |
| Measure: | Dose Limiting Toxicities of the combination |
| Time Frame: | From first dose of protocol treatment until 49 days post treatment |
| Safety Issue: | |
| Description: | Determine dose limiting toxicities of the combination |
| Measure: | Progression free survival (PFS). |
| Time Frame: | From 1st dose of treatment until 1st radiologic disease progression, unequivocal clinical progression, or death due to any cause censored at the last scheduled disease assessment on study if no progression date registered, assessed up to 24 months. |
| Safety Issue: | |
| Description: | Estimate the time from first dose of protocol treatment until first radiologic disease progression, unequivocal clinical progression, or death due to any cause censored at the last scheduled disease assessment on study if there is no progression date registered. |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Not yet recruiting |
| Lead Sponsor: | Abramson Cancer Center of the University of Pennsylvania |
Last Updated
April 22, 2021
