Clinical trial · Interventional
Tocilizumab and Atezolizumab in Adults With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Refractory to 1st Line Immune Checkpoint Inhibitor-Based Therapy
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
NCT04691817CI-TRIAL-00100269recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a research study to evaluate the safety and effectiveness of tocilizumab in combination with atezolizumab to treat non-small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer, Nonsmall Cell | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab | ALIAS |
| Tocilizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Atezolizumab and Tocilizumab
- description
- Participants receive Atezolizumab 1200mg IV and Tocilizumab 6mg/kg IV (or Tocilizumab 4mg/kg IV) every 21 days
- interventionNames
- Drug: Atezolizumab
- Drug: Tocilizumab
Primary outcomes (1)
- measure
- Overall response rate (ORR)
- timeFrame
- From first dose of protocol treatment until radiologic disease assessment at 12 weeks.
- description
- Assess the proportion of patients with a radiologic response by RECIST 1.1 at 12 weeks.
Secondary outcomes (3)
- measure
- Overall survival (OS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.